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Chlamydial infection in pregnancy

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Chlamydial infection in pregnancy
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Schmitt, Karla
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Sexually transmitted diseases ( jstor )
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Women ( jstor )
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CHLAMYDIAL INFECTION IN PREGNANCY:
AN ASSOCIATION WITH LOW BIRTH WEIGHT












By

KARLA SCHMITT


A DISSERTATION PRESENTED TO THE GRADUATE SCHOOL
OF THE UNIVERSITY OF FLORIDA IN PARTIAL FULFILLMENT
OF THE REQUIREMENTS FOR THE DEGREE OF
DOCTOR OF PHILOSOPHY

UNIVERSITY OF FLORIDA


1999































Copyright 1999

by

Karla Schmitt






























This study is dedicated to my parents John and Ardelle Schmitt. Their life has long
been an example of hard work, love and commitment to each other, their children and
grand children. They have always provided generous support to the dreams we each have
had and more importantly never doubted our ability to achieve them. They will always
remain a powerful influence and beacon light for the path ahead, and for each of
'"my tomorrows."














ACKNOWLEDGMENTS

I would like to thank my committee chair, Dr. Sharleen Simpson, who for the

duration of several years and from great distances has been a mentor and provided

generous guidance. And each of my committee members, Dr. Charles Mahan, Dr. Donna

Treloar, Dr. Lois Malasanos and Dr. James Stansbury, the contribution of their expertise

and, most notably, their consistent availability for consultation.

I would like to acknowledge with appreciation the following individuals whose

contributions have been significant and without whom this study would not have

happened! The relational database was prepared through the assistance and many hours

contributed by Alwin Chang, Ken Kampert, Melodee Dew and Karen Freeman. Dan

Thompson provided generous time and support to all steps of the statistical analyses. Phil

Moncrief provided willing guidance on my interpretation of the case morbidity system and

syphilis findings. The patient teaching of many colleagues strengthened the scope of

content contained in this work. The extensive assistance ofDeberah Keith provided

organization to my wandering path on countless occasions. Jack Wroten encouraged my

professional growth and achievement through his exemplary leadership, and allowed me

the opportunity to explore a topic of enduring interest.

Finally, I would like to thank my family and friends for their loving support words

of encouragement, tolerance, nourishing meals and many spontaneous acts of kindness.














TABLE OF CONTENTS




Page
ACKNOW LEDGM ENTS.............................................................................................. iv

LIST OF TABLES........................................................................................................ vii

LIST OFFIGURES........................................................................................................ ix

ABSTRACT............................................................................................................. x

CHAPTERS

1 INTRODUCTION ..................................................................................................... 1
Problem Statement ............................................................................................... 1
Purpose of the Study............................................................................................ 4
Research Question ............................................................................................... 4
Definition of Terms.......................................................................................... 5

2 REVIEW OF THE LITERATURE............................................................................ 9
Epidemiology and Prevalence of Chlnamydia trachomatis ...................................... 9
Epidemiology and Prevalence of Low Birth Weight............................................ 25
Biology of Chlamydia trachomatis..................................................................... 27
Developmental Cycle ................................................................................... 30
Pathophysiology and Pathogenesis................................................................ 34
Laboratory Diagnosis of Chlamydial Infections................................................... 38
Confounding Factors and Quality of STD Specimens Submitted for Testing....... 43
Standards on Gen-Probe PACE2C Testing Techniques Within Florida.............. 46
Risk Factors for Low Birth W eight................................................................. 47
Contribution of Psychosocial and Behavioral Factors.................................... 48
Contribution of Physiological and Medical Care Factors............................... 50
Contribution of Sexually Transmitted Diseases............................................. 59

3 M ETHODOLOGY .................................................................................................. 64
Research Design ................................................................................................64
Protection of Human Subjects ............................................................................ 65
Confidentiality...................................................................... ........... ............. 65









Data Sources ...................................................................................................... 66
Birth and fetal death records ......................................................................... 66
Healthy Start prenatal screen ........................................................................ 70
Maternal and infant laboratory test report database ....................................... 73
M aternal and infant case morbidity database ................................................. 78
Congenital syphilis database ................................................. ........... ......... 80
Methodological Issues in the Use of Administrative Databases........................... 81
Definition of Study Variables .............................................................................. 83
M methods ofAnalysis .................................................................. ......................... 94
Development of the relational database ......................................................... 94
Descriptive analyses ................................................................ ..................... 97
Logistic regression ........................................................ ........... .................... 98
Inclusion and Exclusion Criteria ......................................................................... 99
Assumptions............................................... ..................................................... 100
limitations of the Study Design and M ethodology ........................................... 100
Strengths of the Study Design.......................................................................... 103

4 RESULTS............................................................................................................. 104
Results of Linking the Respective Databases .................................................... 104
Descriptive Comparison of the Relational Database and Study Sample............. 110
Descriptive Comparison of the Dependent and Independent Variables .............. 120
Bivariate Analysis ..................................................................................... ....... 122
Descriptive Analyis of 1996 Statewide Gen-Probe PACE2C Results ............... 128
Logistic Regression Results ...................... ........................................... ............. 131
Other STD Related Study Findings of Interest .................................................. 153
Outcome of Research Question ........................................................................ 156

5 DISCUSSION AND RECOM MENDATIONS........................ .............................. 157
Analysis and Discussion of Research Findings .................................................. 158
Implications for Clinical Practice...................................................................... 171
Implications for Public Health Policy................................................................ 174
Implications for Future Research ...................................................................... 179

LIST OF REFERENCES.................................................................................. ........... 182

APPENDIX A
VARIABLE LIST ....................................................... ............................ ......... 213

APPENDIX B
SYNTAX ......................................................................................................... 218

BIOGRAPHICAL SKETCH ......................................................................................... 235














LIST OF TABLES


Table page

1. Comparison of Low Birth Weight Rates: Florida and United
States, 1989- 1997 ...................................................................... 26

2. Historical Milestones in the Recognition and Study of
Chlamydia trachomatis................................................................................. 28

3. List of all Variables Used in Analysis .................................................. 84

4. Total Records Linked to the 1996 Birth and Fetal Death Records ............... 108

5. Study Sample Records Linked to the 1996 Birth and Fetal........................ 109
Death Records

6. Comparison of Select Demographic Variables Between Relational
Database and Study Sample ...................................................................... 112

7. Comparison Between Relational Database and Study Sample of
Select Variables Used in Combination to Create
Independent Indicator Variables for the Logistic Modeling .....................117

8. Comparison Between Relational Database and Study Sample of
Records Identified for Use as the Dependent Indicator Variables...............121

9. Comparison Between Relational Database and Study Sample
of Records Identified for Use as the Independent Indicator Variables....... 123

10. Unadjusted Odds Ratios for Low Birth Weight, Based on Bi-variate
Analysis of Independent Variables in the Study Sample ...................124

11. Unadjusted Odds Ratios for Term Low Birth Weight, Based
on Bi-variate Analysis of Independent Variables in the Study Sample ....... 126












12. Unadjusted Odds Ratios for Pro-Term Low Birth Weight, Based
on Bi-variate Analysis of Independent Variables in
the Study Sample ........................................................................127

13. 1996 Statewide Chlamydia and Gonorrhea Prevalence Estimates based on
Laboratory Test Results ......................................................... 130

14. Adjusted Odds Ratios, Based on Logistic Regression,
for all Variables ........................................................................ 133

15. Adjusted Odds Ratios, Based on Logistic Regression,
without Race Variable .................................................................. 137

16. Adjusted Odds Ratios, Based on Logistic Regression,
for White Race ......................................................................... 140

17. Adjusted Odds Ratios, Based on Logistic Regression,
for Black Race .......................................................................... 143

18. Adjusted Odds Ratios, Based on Logistic Regression,
for Inadequate Weight Gain .......................................................... 147

19. Adjusted Odds Ratios, Based on Logistic Regression,
for Adequate Weight Gain ........................................................... 151

20. Comparison of Sexually Transmitted Disease Findings for
the Study Sample ....................................................................... 155














LIST OF FIGURES



Figure page

1. Chlamydia Rates Per 100,000 Females, Aged 15-44 Years:
Florida and the United States from 1994 1998 ..............................10

2. Chlamydiales Tree ........................................................................ 29

3. The Developmental Cycle of Chlamydiae ............................................. 32

4. Primary Steps in Research Analysis ................................................. 106














Abstract of Dissertation Presented to the Graduate School
ofthe University of Florida in Partial Fulfillment of the
Requirements for the Degree of Doctor of Philosophy

CHLAMYDIAL INFECTION IN PREGNANCY:
AN ASSOCIATION WITH LOW BIRTH WEIGHT


By

Karla Schmitt

December 1999

Chair Sharleen H. Simpson
Major Department: College of Nursing

The purpose of this study was to determine whether infection with Chiamydia

trachomatis during pregnancy was associated with low birth weight. A retrospective

population based study was conducted on a sample of 14,002 records. The records were

extracted from a large relational database constructed from birth and fetal death records,

prenatal risk screening records, sexually transmitted case reports and laboratory test

reports. Extensive independent indicator variables were created to control for potential

interaction between known risk factors and chlamydial infection. Descriptive, bi-variate

and logistic regression analyses were conducted.

Statistically significant associations were observed among women with inadequate

weight gain, chlamydia infection and low birth weight at 95% confidence interval (OR

1.98, p <0.02). A stronger association was observed with pre-termnn low birth weight (OR








2.34, p <0.01). Other risk factors identified as strongly associated with low birth weight in

this population were mother reporting a history of prior poor pregnancy outcome, alcohol

use, smoking, mother having been low birth weight herself

Among women who had adequate weight gain, gonorrhea infection increased the

likelihood ofhaving a pre-term low birth weight infant by more than five times (OR 5.11,

p<0.003). Women of black race and smoking were also significantly associated with low

birth weight in this group.

This study indicates that chlamydia infection in pregnancy is strongly associated

with low birth weight and that along with other sexually transmitted infections is a

significant public health problem that warrants further investigation.














CHAPTER 1
INTRODUCTION




Problem Statement


Chlamydia trachomatis is the most commonly reported sexually transmissible

disease in the United States since 1995. The national rates for Chlamydia trachomatis are

particularly high among women, ranging from fewer than 150 to more than 300 cases per

100,000 female population during recent years (CDC, 1996a, 1997c, 1998a). Among

populations of childbearing women, case report rates vary by age, race, socioeconomic

status, service setting, and area of the country. Young women are most at risk for

infection, with national case report rates during 1997 as high as 2,044 per 100,000 among

females age 15-19 years and higher in Florida at 2,208 per 100,000 among females age

15-19 years (CDC, 1998a; Florida Department of Health, 1997a).

Trends in prevalence rates for chlamydia are not well established because, while

some states have been reporting the disease since the 1980s, others began as recently as

1995. A national survey of 405 facilities indicated that the number of facilities that

provided testing for chlamydia increased, from 160 in 1993 to 288 facilities in 1994, the

year of the survey (Beck-Sague et aL, 1996). In the population from which this study

sample was drawn, the estimated prevalence of chlamydia among pregnant women

during 1995 was 9.1% in those under 14 years old, 8.8% in women aged 15-19 years, and








5.5% in those aged 20-24 years. The rates were lower among women more than 24 years

old (Schmitt, 1996a).

Close to 80% of infected females and more than 65% of infected males are

asymptomatic (Gaydos et aL, 1998; Quinn et aL, 1996; Schmitt, 1996b, 1999). Hence the

potential exists for undetected and untreated infections, or inadequately treated

chlamydial infections to lead to significant morbidity, with an increased risk of

postpartum endometritis, ectopic pregnancy, pelvic inflammatory disease, salpingitis,

preventable infertility, chronic pain syndromes, septic disseminated infection,

spontaneous abortion, pre-term labor, or even death. In the infected neonate chlamydial

infections are associated with pneumonia, otitis media, and conjunctivitis (Batteiger,

Fraiz, Newhall, Katz, & Jones, 1989; Brunham, Holmes, & Embree, 1990; CDC, 1998b;

Berman et aL, 1987; Askienazy-Elbhar, 1996; Genc & Mardh, 1996; Harrison &

Alexander, 1990; National Academy of Sciences, 1996; Gencay et aL, 1995; Datta et aL,

1988). Chlamydia trachomatis has also been associated with adult and childhood

myocarditis and atherosclerosis (Muhlestein et al., 1996; Grayston, Mordhorst, & Wang,

1981). Pathologic synergism has been identified between chlamydia and cervical

dysplasia (Paavonen, Koutsky, & Kiviat, 1990; Yla-Outinen et aL, 1990). Chlamydia has

also been shown to enhance transmission of human immunodeficiency virus infection by

three to four fold (Laga et aL, 1993; Plummer et al., 1991).

During the last decade there has been an increased awareness of chlamydial

infections and reporting of most identified cases of chlamydia (CDC, 1995, 1996b,

1998b). The epidemiology of Chlamydia trachomatis during pregnancy suggests a range

of prevalence from less than 6% to over 20%, depending on the age, clinic setting and








area ofthe country (Allaire, Huddleston, Graves, & Nathan, 1998; Gittens, Nichols, &

Apuzzio, 1994). Recent research suggests that the bacteria invade human host cells

within minutes, cross the placental barrier to invade amniotic cells, and cause

chorioamnionitis (Patton et aL, 1998; Thomas, Jones, Sbara, Cetrulo, & Reisner, 1990).

During the period from 1981 to 1997, the rates of low birth weight (LBW) have

overall decreased from 8.8% to 7.5% nationally (Ventura, Martin, Curtin, & Mathews,

1999). However, since 1988 there has been a creeping upward trend from 6.9 to 7.5 in

1997, the highest since 1973. During this similar period of time in Florida, there has been

an increase from 7.5% in 1980 to 8.1% in 1998 (Office of Vital Statistics, 1996a, 1999).

Not the entire upward tread is attributable to increases in multiple births among older

women secondary to treatment for infertility. Multiple contributing factors have been

identified. Nationally, low birth weight among singleton births rose from 6.03% in 1996

to 6.08% in 1997, or 4% since 1986 (Ventura, Martin, Curtin, & Mathews, 1999). The

group most affected were black women with an increase of 10.3%. Recent analyses of

Duval County, Florida births suggest the following factors may be involved with the

changing rates: 1) increased numbers of multiple deliveries, by 0.36 for 1998 over the

prior year; 2) increased LBW among multiple births, especially twins; 3) LBW among

singleton deliveries has increased; 4) increased numbers ofbirths to women of black

race/ethnicity, up 3% in 1998; and 5) a downward trend for births reported with

macrosomia (Gest, Thompson, & Hopkins, 1999).

Nationally the numbers of women who initiated prenatal care early and received

at least the recommended number of visits increased during the period from 1981 to 1995

(Kogan et al, 1998). Yet the rates of low birth weight have continued to rise slowly. One








possible factor may be the understudied role of sexually transmitted infections in adverse

pregnancy outcomes. A recent study estimates that 4.8% of LBW is attributable to

infection with Chlamydia trachomatis during pregnancy in populations with positive test

results comparable to that observed in statewide samples (Mittendorfet aL, 1994).



Purpose of the Study

This investigator and colleagues conducted a prior pilot study with 2,885 birth

records and Chlamydia trachomatis test results during 1997. The findings from this

Florida study found LBW rates were slightly lower in the sample population than in the

statewide population. Among the women with positive test results for chlamydia during

pregnancy, the LBW rate exceeded that of women with negative test results. Adjusted

LBW odds ratios for chlamydia, smoking, and black race were significant at the 95%

confidence level Odds ratios were 2.17, 2.49, and 2.09 respectively. The adjusted odds

ratios of chlamydia and smoking were highest for term LBW, 2.68 and 2.93, respectively.

Therefore this larger study was designed to further examine potential associations

between Chlamydia trachomatis and birth outcomes among a population-based sample of

pregnant women and adolescents who initiated prenatal care through county health

departments.



Research Question

The following research question was asked in this dissemrtation: What associations)

exists) between low birth weight and Chiamyia trachomatis infection during pregnancy?








Definition of Terms

The following definitions were used in this study.

Asymptomatic refers to an absence of symptoms e.g., discharge from urethra or

vagina, vulvar itching, intermittent pelvic pain, change in menstrual flow or consistency,

burning on urination, or vaginal discharge with an odor. Symptoms are different from

signs that the clinician identifies as indicative of the presence of infectious processes e.g,

"frothy green discharge versus adherent white clumping discharge," painless ulcer

visualized on the surface of the cervix, or palpable mass on the ovary. At times symptoms

may be present but the individual may not recognize them as such due to their frequency

of occurrence, or unawareness of their relevance in regard to their health, e.g., inter-

menstrual spotting.

Chlamydia is the common term used to refer to Chilamydia trachomatis. It is the

most common sexually transmitted infection in the United States, capable of causing

long-term adverse and permanent sequelae.

Chlam a trachmtis is an obligate intracellular parasite that requires a host cell

in order to live and reproduce. In the context of this study those serovars that cause

genital and congenital infections are the reference. Several other serovars are the cause of

lymphogranuloma venereum or "LGV."

DNA hybridization is a laboratory technique used to increase the likelihood of

detecting genetic material specific to chlamydia and gonorrhea present in the test

specimen. This technique is used for Gen-Probe PACE2 testing and was employed by

the laboratories participating in this study.









EIA, enzyme immunoassay, is one of the earlier non-culture tests for chlamydia.

This method detects chlamydial antigens measured by enzyme-linked immunoassay with

polyclonal or monoclonal antibodies.

Fetal growth restriction or retardation is defined as a birth weight and height

below the 10& percentile for a specific gestational age. Another term that is often used

interchangeably is "small for gestational age."

Gonorrhea is the common term used to refer to Neisseria gonorrhoeae, a gram-

negative intracellular diplococcus, predominantly sexually transmitted, and capable of

causing long-term adverse sequelae when untreated.

Inadequate specimen indicates a Gen-Probe test specimen that does not contain

enough cellular material to test for the presence of Chlamydia trachmatis or Neisseria

gonorrhoeae.

Indeterminate is a term used to report specimens that do not fall distinctly within

the parameters used to measure relative light units on Gen-Probe testing equipment. This

may indicate a specimen that is a false negative, a false positive, or a specimen that had

inadequate quantity on which to complete the confirmatory test.

Late syphilis is a term used to refer to the period of syphilis infection that

continues after the cessation of clinical manifestations and symptoms, associated with

primary and secondary syphilis infection. The organism, T. Pallidun, is still present,

primarily in the spleen and lymph nodes. Early latent syphilis spans the period of the first

year of infection. Late latent begins one year after infection, and may last a life time. As

during primary and secondary syphilis, a pregnant woman with latent syphilis can








transmit the infection to the fetus in utero. Tertiary syphilis may occur at anytime during

latency and congenital transmission at this stage is rare.

LCR is a brand name for ligase chain reaction, which is based on polymerase

chain reaction, a DNA amplification technology.

Low birth weight (LBW) is the term used to indicate a live born infant whose

weight is less than 2,500 grams.

Pooling is the term used to indicate a testing methodology where a portion of

multiple specimens are combined in a single vial and all are tested simultaneously. If

negative, all are reported out as negative. If the pooled result is positive, then each

specimen must be fixurther tested individually to identify the positive specimen. In

populations with low prevalence, pooling is a cost saving procedure that conserves

reagents. h is not useful in populations with high prevalence of infection.

Pre-term low birth weight (PTLBW) is the term used to indicate a live born infant

whose weight is less than 2,500 grams and less than 37 weeks gestation.

Sensitivity of a test as used in this study, is the probability of the Gen-Probe test

to report a positive test in an individual truly infected with Chlamydia trachomatis or

Neisseria gonorrhoeae.

Serology is the term used to indicate a laboratory test technique using blood

serum for testing. This is also commonly used to indicate a syphilis blood test.

Serovars of ChlwnMydia species appear to be associated with different levels of

immune response and virulence in the human host.








Specificity of a test as used in this study is the probability of the Gen-Probe test to

report a negative test in an individual truly not infected with Chiamydia trachomatis or

Neisseria gonorrhoeae.

STD or STI refers to sexually transmitted diseases or infections. In the past this

group of infections was known as "venereal diseases." These are the "commonly" known

STDs and other STDs less well known to clinicians and the public as sexually

transmittable. The commonly known STDs include syphilis, gonorrhea, trichomonas,

chlamydia, and HIV. Cytomegalovirus, hepatitis B and C, group B Streptococcus, and

bacterial vaginosis are among those infections less well recognized as sexually

transmitted. Those infections for which common and reliable testing is available are

routinely reported to state health agencies as required by law. For other less frequently

reported infections, there are generally no reasonably priced and sensitive tests available

for use by clinicians to assist in diagnosis. As a consequence, reporting is dependent upon

clinician recognition of syndromes and diagnosis.

Term low birth weight (TLBW) is the term used to indicate a live born infant

whose weight is less than 2,500 grams and 37 or more weeks gestation.

Unsatisfactory specimen indicates a Gen-Probe test specimen that contains

excessive amount of blood, mucous, or other material that interferes with the testing

procedure and is reported as an unsatisfactory specimen.

Very low birth weight (VLBW) is the term used to indicate a live born infant

whose weight is less than 1,500 grams and less than 37 weeks gestation.














CHAPTER 2
REVIEW OF THE LITERATURE



The specific aim of this chapter is to review the literature relevant to the research

question. This chapter will consist of eight sections. The epidemiology, biology, and

pathogenesis of Chlamydia trachomatis will be reviewed. The epidemiology of low birth

weight and common risk factors for low birth weight will be covered in other sections.

Finally laboratory diagnosis of chlamydial infections, confounding factors related to

specimen collection, testing standards for the specific test used in this study, and the

sensitivity and specificity of tests available for the detection of Chamydia trachomatis will

be discussed.



Epidemiology and Prevalence of Chlamv/a trachomatis


"Infection in the female reproductive tract (especially in the cervix) can cause

premature rupture of membranes and induce premature labor [and] this is responsible for

many preventable infant deaths," 1950 quote attributable to L C. Knox and J. K. Homer

(McGregor & French, 1997).

Chlamyia trachomatis has led the list of nationally reportable diseases since 1995.

Chlamydia and other sexually transmitted diseases such as gonorrhea, AIDS, primary and

secondary syphilis, and hepatitis B accounted for 87% of the top ten most frequently








reported diseases in 1995 (CDC, 1996b). National reporting for chlamydial infections

dates to 1995 (with the exception of the state of New York, as only New York City

reports, and of Georgia, where only cases diagnosed in women are reportable). The

estimated incidence of chlamydia cases is 4 million annually in the United States, mostly

among adolescents and young adults (National Academy of Sciences, 1996). In Florida

during 1996, Chamydia tracmatis accounted for 52.6% of all sexually transmitted

disease case reports, with 81.3% from females and with 78% from women of reproductive


--- 15-34 US -- 15-44 FIl -- 15-44 US


-- 15-34 F
"s 1 -----1


6W 4 A- -- e-"
W at l, -





| 200-
0
19941 19951 1996 1997 1998
Year
'US data 1994 1995 not available.
Contat from: Florida Departmmt of Health, 1999; CDC, 1998a, 1999a.

Figure 1. Chlamydia Rates per 100,000 Females, aged 15-44 Years: Florida and the
United States, 1994- 1998.

age of 15-44 years. The distribution is markedly more notable among the youngest of

women with about 44% of cases reported from those between the ages of 15 and 19

years. Figure 1 compares the rate of reported cases per 100,000 female population aged

15-34 years and 15-44 years in Florida to the United States.








Widespread screening activities among different populations and clinic settings

have demonstrated rates of infection from 3% to 25%. The positive rates in 1997 among

women 15-24 years of age, screened in family planning clinics nationally ranged from less

than 4% to greater than 11% (CDC, 199T7b). A national population based survey of 1,144

participants aged 12 to 39 years, of whom 54% were female, demonstrated a 10%

chlamydial infection from urine specimens (Mertz et aL, 1998). The specimens were

collected from persons not seeking medical care and contacted in their households as part

of the study to estimate the prevalence of various diseases and conditions in a non-

institutionalized United States population. Brodine et aL (1998) using ligase chain reaction

(LCR) urine technology reported positive rates of 2.7% among female naval personnel

assigned to an anchored ship, compared to 6.9% among those living on the naval base

located on shore. The average ages for these two groups were 25 and 27 years

respectively. Rates drop off significantly in age groups over 24 years, while serologic

evidence rises to about 50% of the population by age 30 years (Stamm, 1988)

Screening for chlamydia conducted in adolescents demonstrates the highest

positivity in the younger ages. Burstein et aL (1998) reported 24.1 % among adolescents

on initial visit and 13.9% on repeat visits. The investigators prospectively examined 3,202

sexually active females, following them for 33 months. Both urine and cervical specimens

were tested by PCR. Rates in female military recruits were also high. Gaydos et aL (1998)

using urine LCR reported chlamydial infection was 9.2% to 12.2% among 17-year-old

recruits, with rates higher for those from five of the southeastern states, Florida not

included. Screening conducted using EIA among U.S. Job Corps females aged 16-24

years during 1990-1994, shows 14.5% for Florida applicants (Shakarishvii, 1995).








Authors reporting on a prospective cohort study among urban adolescents reported initial

chlamydial infection rates of 23.2% and 20.8% at follow-up (Oh et aL, 1996). The study

conducted in the southeastern United States used the tissue-culture method. Specimens

collected for culture ofNeisseria gonorrhoeae were found to be positive for 11.6% of the

study group at their initial examination and again for 17.1 % at the follow-up screening

12-24 months later. This is not an uncommon finding to observe dual infection with

chlamydia and gonorrhea among a certain proportion of any population studied. From 20-

30% of those infected with gonorrhea are co-infected with chlamydia in other studies

(Hook & Hansfield, 1999; CDC, 1998b).

In Florida, during the first half of 1999 the rate ofpositivity for females in family

planning, STD, and prenatal clinics participating in the infertility prevention project was

4.45%, 10.82%, and 6.42% respectively. (Baden, 1999). The positivity for different

groups of young women tested was 5.44% (15-19) and 3.79% (20-24) for young women

in family planning clinics, 12.88% (15-19) and 12.09% (20-24) for young women in STD

clinics, and 9.21% (15-19) and 5.21% (20-24) for young women in prenatal clinics. These

rates are similar to those observed during 1996 and 1998 among these same populations

(Schmitt, 1996b, 1999).

Chamnydia trachomatis is primarily an asymptomatic infection and disease process

known to contribute to widespread community transmission among unsuspecting sexual

partners. Improved testing technologies in recent years have helped elucidate that the

previously believed disparity between asymptomatic infection in males and females does

not really exist. Males and females both have very high rates of chlamydial infections.

Among female populations screened in Florida as many as 80-85% and among males 70-








75% are asymptomatic when infected (Schmitt, 1999). Nationally, the reported

asymptomatic rate ranges from 50-75% (Cates & Wasserheit, 1991). Following exposure

and infection, symptoms may begin within 1 to 2 weeks. Females generally present with

cervicitis however urethritis is also common. Asymptomatic infection of the rectum or

urethra may accompany symptomatic infection of the cervix up to 50% of the time (Cates

& Wassesheit, 1991; Stamm, 1999). Many women will have only mild symptoms of

vaginal discharge, spotting, lower abdominal pain, or dysuria. Infection may also present

as salpingitis, endometritis, peritonitis, Bartholinitis, perihepatitis, pharyngitis, and reactive

arthritis. Adults, like infants, can present with conjunctivitis and cases ofmyocarditis have

been reported (Stamm & Holmes, 1990; Freund, 1992; Bergstrom & Llbombo, 1995;

Berman et at, 1987; Grayston, Mordhorst, & Wang, 1981; Kessler, Pierer, Stuenzaer,

Auer-Grumbach, Hafler, & Marth, 1994).

The natural history of the infection in a nonpregnant woman is one initially of

cervicitis, with ascent to cause salpingitis, sometimes having first caused endometritis en

route. Without treatment, one-fourth to one-half of women with chlamydia will go on to

develop pelvic inflammatory disease (PID), involving inflammation of the endometrium,

fallopian tube(s), and potential involvement of the peritoneunm. Rates of identification of

Chlamydia trachomatis by culture, antigen, or serology in cases of salpingitis and PID

range from 5 to 55% depending on the clinic setting, geographic site, type technology and

country (Cates & Brunham, 1999; Schachter, 1999a). The leading hypothesis for PID

pathogenesis is that endometrial and Chlamydia trachomatis and Neisseria gmonorrhoeae

initiate tubal infection. Then secondary groups of anaerobic and aerobic bacteria may

invade to contribute to the inflammatory disease process (Cates, Rolfs, & Aral, 1990;








Martens, Young, Uribe, Buttram, & Faro, 1993). Reported recovery from women

examined by laparoscopy has ranged from 10% to 80%, with secondary bacteria

recovered much less frequently. More often in clinically milder or "silent PID," chlamydia

is recovered or there is immunologic evidence of recent infection with Chlam)dia

trachomatis (Patton et al., 1994). Tubal scarring and development of tubal infertility

follow the acute or silent PID. This same scarring can set the stage for later life

threatening ectopic pregnancy events. Moore and Cates (1990) suggest that infertility may

follow either acute or clinically detected PID and silent salpingitis. They and others

provide ample evidence to suggest that the majority of tubal factor infertility follows

events of silent salpingitis, in women who report no history of PID but demonstrate

serologic evidence of prior chlamydial infection (Cates & Wasseirheit, 1991; Patton et al,

1989; Westrom, 1975, 1994; WHO, 1995). In contrast the Wolner-Hanssen (1995) in-

depth study using laproscopy and questionnaires suggests that 'silent' PID is secondary to

the failure of the medical community to elicit more complete information from a patient

regarding their menstrual history, abdominal pain, and episodes of infection. The author

does not suggest that chlamydia is not associated with PID, merely that the silent or

atypical status of the PID experienced by women is likely overstated and a result of failure

to elicit complete medical histories.

Studies conducted among pregnant women have identified rates of less than 6% to

close to 33% infected depending on the age, clinic setting, and area of residence. Allaire

and others found a rate of 14.8% among a high-risk indigent obstetric population using

both rNA hybridization and enzyme immunoassay (1998). Nearly 21% prevealce was

reported by researchers who studied an adolescent pregnant group using immunoassay








(Gittens, Nichols & Apuzzio, 1994). In that same study 25% had more than one sexually

transmitted infection. Cohen and colleagues (1990) reported 5.75% prevalence using

direct antigen methods. Another group of researchers who cultured vaginal lavage

specimens after premature rupture of the membranes found 14% positive for chlamydia

(Harger et al, 1991). Nearly 22% prevalence based on culture was reported for initial

prenatal visits among urban lower socioeconomic women (Ryan, Abdella, McNeeley,

Baselski, & Drummond, 1990). Using two antigen detection systems researchers reported

that specimens collected from pregnant women had higher rates of inclusions than those

collected from nonpregnant women. However the difference was not statistically

significant (p < 0.096) in this study conducted with a population whose prevalence was

9.1% among nonpregnant women and 12% among pregnant women (Smith et aL, 1987).

The natural history of the infection in a pregnant woman is less well understood.

There are inconsistent reports and evidence of disease progression from initial chlamydial

infections. Among pregnant women infected with Chlamydia trachomatis, fetal loss has

rarely been reported, premature delivery is experienced by 10-30%, and perinatal infection

by 40-70% (Jones, 1999). There is evidence to support a progression from cervicitis with

ascent to cause intrauterine infection. Greater than 11% of infants born to women with

cervical infection were found to have antichlamydial antibodies in their cord serum (Fejgin

et aL, 1997). Harger and colleagues (1991) reported a different finding ofno chlamydia

positive cultures from amniotic fluid in their study of sub clinical chorioamnionitis among

asymptomatic afebrile women in pre-term labor with intact membranes. Among patients

with premature rupture of membranes in another study, the presence of chlamydial

infection neither increased the incidence of chorioamnionitis nor decreased the latent








period from rupture of membranes to delivery (Ismail, Pridjian, Hibbard, Harth, &

Moawad, 1992). Chlamydia was identified by amniocentesis from a case of induced labor

secondary to suspected chorioanmionitis (Thomas, Jones, Sbarra, Cetrulo, & Reisner,

1990). The cervical specimen was culture positive for Chlamydia trachomatis, CaMndidia

albicans, U urealyticwnum, and group B streptococci. Chlamydial elementary bodies were

identified by fluorescent stain in both amniotic fluid and placental tissue specimens

suggesting that only these organisms ascended from the lower genital tract to cause

infection in the amniotic fluid and fetal membranes.

Stillbirth or neonatal death was reported ten times more often among chlamydia

positive women in a study matched with controls for age, marital status, socioeconomic

conditions, pregnancy order, and race (Martin et al., 1982). This pregnant population had

a cervical infection rate of 6.7%. Gencay et aL reported a stillbirth at 36 weeks gestation

with chlamydia DNA positive placental tissue and histologic evidence of Chlamydia

trachomatis (1995). Thorp and colleagues reported a fetal death at 34 weeks with

histologically confirmed Chlamydia trachomatis pneumonia on autopsy (1989). Fetal loss

perhaps may be more accurately estimated from animal models. Mice models suggest

19.2% intrauterine fetal demise among those chlamydia positive (Oshiro, 1994).

Postpartum endometritis will follow approximately one-third of cases of cervical

infection during pregnancy with development of symptoms at 48 hours after delivery

(Schachter, 1999). As reported by Watts and Brunham (1999), Wager and fellow

researchers in 1980 found 22% of pregnant women with cervical infection during

pregnancy developed late postpartum endometritis (1999). Paavonen et al (1985)

suggested nonpregnancy related chlamydial endometritis is characterized by plasma cell








infiltration of the endometrium. This raises the possibility "that such infections are

associated with failure of implantation or early pregnancy loss due to spontaneous

abortion." However, Sozio and Ness (1998) do not support a relationship between acute

chlamydial infection and the subsequent development of spontaneous abortion.

Bell and others (1994) examined the perinatal transmission in relationship to mode

of delivery. With the use of both culture and serology, they concluded that chlamydia may

be transmitted more often than is suggested by other reports. The transmission rate to the

infant was 60% among infected women delivering vaginally (75 of 125 infants). Those

women who delivered by caesarian section were not significantly less likely to be infected

than those delivered by the vaginal route with cephalic presentation, however the numbers

studied were small (10 infants delivered by caesarian section). Two often infants (20%)

delivered by caesarian section were later found to be infected in the conjunctiva or

nasopharynx. Cord blood was tested for IgM antibody to Chlamydia trachomatis for 26

ofthe infants included in the study. In all cases the cord serology was negative; a positive

IgM which would have indicated prior intrauterine infection.

As with other adverse outcomes of pregnancy, the causal link between known

infection with Chlamywdia trachomatis and LBW has not been conclusively established.

Recent studies have shown an increased risk of low birth weight and premature rupture of

the membranes linked to recent chlamydial infection while others failed to identify any

associations. Gencay et aL (1995) reported that gestational age was longer among IgG

and IgM sero-negative infants. They also found less chorioamnionitis and atelectasis and

pneumothorax among the sero-negative group. In another study designed to examine the

effect of treatment on pregnancy outcome, low birth weight was reported in 19.6% of








those infants with infection who were not treated as compared with 11.0% that were

treated (Ryan, Abdela, McNeeley, Baselski, & Drummond, 1990). This finding was highly

significant, at 95% CI, p<0.0001. Others found an odds ratio of 1.5 for low birth weight

associated with chlamydia positivity (Gravett et al, 1986). Harrison et al (1983) identified

the presence of IgM antibodies among infants born with low birth weight in a population

with 8% prevalence on culture. Martius et at, (1988) reported an even higher odds ratio

of 3.9 for chlamydia positive pregnancies to be associated with premature rupture of

membranes or pre-term labor.

Investigators of the Johns Hopkins Study of Cervicitis and Adverse Pregnancy

Outcome reported an odds ratio of 2.4 for intrauterine growth retardation in a population

with 15.5% positivity (1989). In contrast, Germain and colleagues (1994) found no

association when cultures were taken at 23-26 weeks. Cohen, Veffille, and Calkins (1990)

identified a non-significant reduction in low birth weight and small-for-gestational-age

infants among another treated group when compared to non-treated controls. Hardy et al

(1984) only found association for chlamydial infection and low birth weight if co-infected

with Trichonnas vaginalis. One unique aspect of this study however was the destruction

of the chlamydial McCoy culture cells by the protozoa. This aspect may have confounded

the findings of a lack of an association between low birth weight and chlamydia infection.

In 1991, Much and Yeh observed a significant difference in the incidence of low birth

weight between two groups when one was treated with erythromycin, p 0.05. Clearly

additional data is needed to help clarify the relationship between chlamydial infections

during pregnancy and adverse outcomes.








The difficulty even in the existence of either epidemiologic or statistically

significant evidence for a relationship between chlamydial infection and adverse pregnancy

outcomes is that neither type of study has provided enough information about the

sequence of events. Therefore it is difficult to demonstrate a direct cause and effect

relationship between chlamydial infections and adverse pregnancy outcomes. Additionally,

the variable signs, symptoms, test types, definitions of variables, timing of the specimen

collection during the pregnancy, and inclusion or exclusion of specimen collection to test

for other STDs reduces the value of prospective cohort studies conducted to explore the

associations between Chlamydia trachomatis and pregnancy outcomes.

In the United States Chlamydia trachomatis is primarily a sexually acquired genital

infection. However the infection is also a serious congenitally acquired infection. Risk of

any chlamydial infection among infants born to infected women is estimated at 50% to

75%. Between 35% to 50% of infants born to infected mothers will go on to develop

conjunctivitis and 8% to 22% will develop pneumonia (Harrison & Alexander, 1990;

Crombleholmhne, 1991). "Initial perinatal infection involves mucous membranes of the eye,

oropharynx, urogenital tract, and the rectum" (page 57, CDC, 1998b). The typical course

is inclusion conjunctivitis first noted at 5 to 12 days of age. If left untreated conjunctivitis

may result in corneal scarring and vascularization. It may also be aysmptomatic and self-

limited (Schulz, Schulte, & Berman, 1992).

Among infants born to infected mothers, 20% to 50% wll develop conjunctivitis

and 10% to 20% will develop pneumonia and chlamydial respiratory disease syndrome,

with increased sensitization of the infant to further chlamydial infections (Datta et aL,

1988; Schachter et al., 1986). Schachter et al (1986) reported sub-clinical rectal and








vaginal infections in 14% of infants at risk ,secondary to exposure during birth to maternal

infection. Of interest is the variable temporal delay between sites for identification of

positive isolates. All conjunctival infections were detected in less than three weeks.

Nasopharyngeal infection was detected sporadically during the first three months, often in

the later period with pneumonia. Neonatal rectal isolates overall were detected after two

months.

Datta and colleagues (1988) suggested that appreciable infant morbidity might be

associated with higher rates of chlamydial prevalence in pregnant women. In their cohort

study they compared morbidity in chlamydia exposed infants to non-exposed infants.

Among the exposed infants, 37% developed opthalmia neonatorum, and 12% pneumonia

(with one fatality). The reported rates of sequelae among those neonates exposed to

Chlamydia trachomatis ranged from 12% to 80% for ocular infection, and pneumonia, as

compared to 0% to 60% in the non-exposed group of infants. This study was a sub-sample

of a parallel study comparing the efficacy oftetracycline ointment and silver nitrate

solution for postnatal ocular prophylaxis, (Laga et aL, 1988). Inadequate treatment

response was reported to each of the ocular prophylaxis for both conjunctival

complications and pneumonia, extending the morbidity effect. Overall, the incidence of

opthalmia neonatorum was reduced by 77% with the use of tetracycline ointment and 68%

with the use of silver nitrate solution. Pnuemonia remained the major complication among

infants with perinatally acquired chlamydia. The occurrence of both chlamydia pneumonia

and opthahnia neonatorum was not prevented by ocular prophylaxis (CDC, 1998b).

The epidemiology of opthalmia would suggest that there is a disparate relationship

between the prevalence of chlamydia in the community and the recognition ofnewborn








cases, due to the uncommonly low reporting levels. Authors of one recent survey study

found that providers only reported 42% of gonorrhea, 56% of chlamydia and 58% of

primary and secondary syphilis diagnoses (Hammett, Kaufinan, Faulkner, Hoagin, &

Battaglia, 1996). Between the years 1994 and 1997 the total number of reported

chlamydia opthalmia cases for the United States ranged from 152 to 262, while for the

same period 48 to 1,560 cases of gonorrhea opthalmia were reported (CDC, 1995, 1996b,

1997b, 1998a). These reported cases inversely reflect the level of reported gonorrhea

nationally in women of reproductive age.

Additionally, one is reminded of the inefficacy of drugs currently used for ocular

prophylaxis of chlamydia opthalmia at the time of delivery (CDC, 1998b). Drugs currently

recommended for ocular prophylaxis include 1 percent silver nitrate, 1 percent tetracycline

ointment and 0.5 percent erythromycin (Gutman, 1999; Schachter et al., 1986). While

efficacy of these drugs is high for prevention of gonoccocal opthamhnia, their efficacy for

preventing chalmydia opthalmia is unacceptable. In short, there is no "gold standard" at

present for efficacious and comprehensive ocular prophylaxis. Hammerschlag (1999)

summarizes the numerous studies and concludes that the information is inconclusive. He

notes that none of the drugs studied for ocular prophylaxis is reported to be universally

efficacious. He ultimately recommends that effective screening and treatment during

pregnancy remains the most effective method of control

Diagnostic and political considerations further complicate the situation. Nearly all

cases of opthalmia are diagnosed after discharge from the hospital Such cases are often

sub-acute and diagnosis requires appropriately collected specimens that contain

conjunctival cells, not exudate alone, and the use of sensitive and specific tests. Many








clinicians would prefer not to suggest to parents) that a newborn infant be tested for a

sexually transmitted disease. Accordingly many will empirically treat infants exhibiting

suggestive symptoms with antibiotic ointments, without collecting a specimen.

Consequently there are no positive test results reported to authorities. No comprehensive

review of all causes ofneonatal opthaimia and pneumonia has been conducted nationally

or in Florida in recent years. In one study conducted in Florida the authors identified a

higher association between gonorrheal opthalmia with hospitals using eyrthromycin for

ocular prophylaxis (Desenclos, Garrity, Scaggs, & Wroten, 1992).

Infants may also present with pneumonia, following intra-partum exposure to

Chlamyndia trachomatis (Stamm & Holmes, 1990; Freund, 1992). Chlamydial pneumonia

is a far more serious disease sequelae in this country than is conjunctivitis. Often infants

may continue to have reduced pulmonary capacity well into childhood. This is

demonstrated by abnormal pulmonary function tests and obstructive lung disease as

identified in the study by Weiss et al., 1986 (as cited in Hammerschlag, 1999). Between 8

to 22% of infants born to infected mothers will develop pneumonia (Harrison &

Alexander, 1990; Crombleholme, 1991). Chlamydial pneumonia presents with a repetitive

staccato cough accompanied by tachypnea. Hyperinflation and diffuse infiltrates are noted

on chest x-ray. Fever and wheezing are uncommon. Reliable diagnosis is a more invasive

affair than testing for ocular infection, with tracheal aspirates and tissue culture more

sensitive and specific than nasopharygeal specimens for non-culture testing. Effective

treatment often requires a second course of the recommended antibiotic therapy, due to

only 80% efficacy of the recommended eyrthromycin (CDC, 1998a).








There are less common reports of adult conjunctival infection. Conjunctivitis of

adults results from hand-to-eye self inoculation or partner inoculation during sexual

contact. Worldwide conjunctival Chlamydia trachomatis is primarily an endemic disease,

spread person-to-person or through unsanitary conditions. Affecting several hundred

million persons the disease process is both hyperendemic and holoendemic resulting in

blindness for millions of people. In holoendemic areas young children acquire the

infection, primarily from infected individuals or unsanitary conditions, with many infected

by two years of age. In these communities the rates of blindness are the highest following

a process of chronic follicular keratoconjunctivitis that results in corneal damage and

scarring of the eyelid. Many infected persons in hyperendemic areas sustain less permanent

damage, however blindness or badly scarred conjunctiva are not uncommon (Schachter,

1999a; Schachter, 1999b). Lymnphogranuloma venereum (LGV) is another manifestation

of chlamydial infections, caused by serovars LI, L2, L3 and L4 and affecting lymphatic

tissues. After a process of inflammation there is formation of abscess, fibrosis, and

obstruction of lymphatic pathways and disfigurement.

Only recently, literature has begun to identify cervical cancer as a sexually acquired

condition. Primarily these associations are based on studies examining the role of human

papilloma virus. A few studies have suggested that Chkmwydia trachomatis may contribute

a more direct effect to the development of cervical dysplasia rather than act only as a

synergistic bystander (Paavonen, Koutsky, & Kiviat, 1990; Lindner, Geerling, Nettum,

Miller, & Atman; Yla-Outinen, Lehtinen, Romppanen, Luoto, Rantala, & Paavonen,

1990). Recently Paavonen (1999 as cited by Jancin, 1999) reported that Chlamydia

trachomatis was significantly associated with invasive squamous cell cervical carcinoma.








This association was significant after adjustment and in the presence of IgG antibodies to

the serovars G (OR 6.6), D (OR 3.1), I (OR 4.4) and E (OR 2.3).

Other researchers have identified that cervical epithelial changes are significantly

associated with several reproductive tract infections Singh and colleagues (1995)

examined a population of women attending a maternal health center in New Delhi, India.

A specimen was collected for a Pap smear. Other specimens were collected to screen for

chlamydia, gonorrhea, trichomoniasis, bacterial vaginosis, herpes simplex virus, genital

warts, HIV, syphilis, and candidiasis. If indicated, the woman also received a colposcopic-

directed biopsy for any atypical lesions. After controlling for interaction the adjusted odds

ratio for an association with inflammatory epithelial changes and chlamydia was 21.3, 13.5

for human papillomavirus, and 22.6 for bacterial vaginosis. They observed a significant

additive effect: two infections increased the magnitude of inflammatory changes by

adjusted OR 31.4 and three infections by 72.6 fold. Young age was mildly protective and

parity greater than one increased the risk by OR 1.7

Today in an age of fatal STDs like HIV the rate of chlamydial infection in a

community is epidemiologically significant. A growing body of research provides evidence

that the population attributable risk from chlamydial infections is a predictor of increased

HIV transmission rates among young women and their partners (Laga et aL, 1993;

Plummer et aL, 1991). These researchers studied prostitutes prospectively and reported

adjusted odds ratios associating chlamydia with HIV-1 sero-conversion ranging from 3.2 -

5.7 with a median of OR 4.5. Laga and colleagues also calculated a population attributable

risk in their study population of 22% for increased HIV transmission in the presence of








cervical chlamydia. This was more than five time the attriutable risk from genital ulcer

disease in this group.

In summary Chiamydia trachomatis is associated with a profound scope of disease

manifestation in the reproductive age woman. These processes range from mildly annoying

symptoms to life threatening events. When pregnant women are infected with this bacteria

the sequelae may range from spontaneous abortion, premature rupture of membranes, pre-

term labor to vertical transmission that results in low birth weight, stillbirth, and infantile

pulmonary infections that may cause lifelong damage to the infant's respiratory system.

The fill impact of this sexually transmitted infection remains to be establishedL


Epidemiology and Prevalence of Low Birth Weight

The Florida Office of Vital Statistics reported the rate of low birth weight was

8.5% in 1970 and dropped to 7.5% in 1980 (Office of Vital Statistics, 1996a). Between

the years from 1985 to 1995 the LBW rate hovered between 7.4% and 7.8%. From 1996

there has been a gradual upward shift to 8.1% total LBW for 1998, with an incrementally

upward change also for very low birth weight (VLBW) over the same period (Office of

Vital Statistics, 1999). The observations about rates in Florida mirror the gradual upward

shift in percentage of low birth weight reported nationally. However the national rates for

1998 are not yet available for comparison. Overall the percent of VLBW and total low

birth weight is higher in Florida than for the United States over the period of time

presented in Table 1 below.

Nationally the percentage of low birth weight for singletons among Hispanic

women has changed very little since 1989 at 5.35% to 1997 at 5.43.% The rate among








non-Hispanic black women has declined slightly during this same period from 12.22% to

11.46%. Among white non-Hispanic women, there has been more fluctuation with an

overall trend that has been a slightly upward from 4.60% in 1989 to 4.95% in 1997

(Ventura, Martin, Curtin, & Mathews, 1999), The rate of low birth weight among

adolescents 15 to 19 years old in Florida during 1996 was 1.9% for very low birth weight

and 9.9% for low birth weight. These numbers are comparable to national rates for low

birth weight at 9.5%.

Table 1. Comparison of Percent of Low Birth Weight: Florida and the United States,
1988-1998.


Florida United States

Very Low Low Birth Very Low Low Birth
Birth Weight Weight <2,500 Birth Weight Weight
<1,500 Grams Grams <1,500 Grams <2,500 Grams

1988 1.4 7.7 1.2 6.9
1989 1.5 7.7 1.3 7.0
1990 1.5 7.4 1.3 7.0
1991 1.4 7.4 1.3 7.1
1992 1.5 7.4 1.3 7.1
1993 1.4 7.5 1.3 7.2
1994 1.5 7.8 1.3 7.3
1995 1.5 7.7 1.4 7.3
1996 1.5 7.9 1.4 7.4
1997 1.5 8.0 1.4 7.5
1998 1.6 8.1 -

Content adapted from Office of Vital Statistics, 1996a, 1999; Ventura, Martin, Curtin, &
Mathews, 1998.


The societal impact from low birth weight infants is enormous in terms of medical

health care costs and other long-term adverse outcomes. The average cost for the first

year of a low birth weight infants medical care has been estimated to exceed $28,058 (this








estimate is from the Office of Technology Assessment, an 1988 estimate adjusted for 1998

dollars by Department of Health, Office of Health Planning and Evaluation.) Recent

analysis on Florida birth records for 1985 to 1990 suggest a significant association

between low birth weight of 1,500 and 2,499 grams and physical impairment (OR 4.35),

profoundly mentally handicapped (OR 4.75), educable mentally handicapped (OR 2.62),

and academic problems (OR 1.26) (Resnick et aL, 1999). Low birth weight infants are at

increased risk ofneonatal and infant morbidity and mortality; nearly 70% of all infant

mortality, nearly one third of all handicapping conditions (Patient Outcomes Research

Team, 1998).


Biology of Chlamydia trachomatis

Chlamydia trachomatis is an intriguing pathogenic bacteria with a long history of

human contact and a distinctly unique growth cycle. Pathology associated with the

bacteria was first described in Egyptian papyri (Schachter, 1999a). Most likely it predates

humankind as a species by billions ofyears. Halberstaedter and Prowazek first stained

conjunctival scrapings from orangutans infected with human trachomatous matter and

demonstrated the presence of inclusions in 1907. In 1914 Lindner isolated inclusions from

the conjunctival of infants, the genital tracts of their mothers, and the urethras of their

fathers (Schachter, 1999a). T'ang and associates contributed the first isolation of

Chlamydia trachomatis from persons infected with LGV during the 1950s (as cited in

Schachter, 1999a). In 1959 Jones, Collier and Smith recovered the bacteria from the

cervix of a woman whose infant had opthalmhnia neonatorum (as cited in Schachter, 1999a).

Other historical milestones are summarized in Table 2 below.








Table 2. Historical Milestones in the Recognition and Study of Chamydia trachwmatis.


B.C.

18e century

1907



1911


e.1930


1941

1950s


1959



1964


1965



1966


1980s

1990s


Egyptian papyri contain description of trachoma.

John Hunter first described Lymphogranuloma Venereum (LGV).

Halberstaedter and Prowazek stained conjunctival scrapings from
Orangutans infected with human trachomatous matter and demonstrated
the presence of inclusions.

Lindner isolated inclusions from the conjunctival of infants, the genital
tracts of their mothers, and the urethras of their fathers.

Chlamydia trachomatis isolated from persons diagnosed with LGV by
Macchiavello. Isolate unfortunately lost before confirmed by others.

Respiratory infection in infants first reported by Botsztejn.

Chlamydia trachomatis isolated from persons diagnosed with LGV by
T'ang and associates and later confirmed by other researchers.

The first isolate of Chlamydia trachomatis from the genital tract (non-
LGV) by Jones, Collier and Smith. Obtained from the cervix of a woman
whose infant had opthalmia neonatorum.

Chlamydia trachomatis recovered from male urethras, in association
with epidemiologic studies of conjunctivitis.

Gordon and Quan developed the first clinically useful laboratory
procedure for diagnosis with a tissue culture isolation technique of
intracytoplasmic inclusions that allowed for results in 48-72 hours.

Dunlap and associates demonstrated that up to one third of men with
nongonococcal urethritis had carriage of Chtamydia trachomatis.

Affordable and sensitive non-culture tests become widespread.

Highly sensitive and specific amplified testing available.


Content adapted from Schachter, 1999b; Hanerschlag, 1999; Chemesky, 1999.











Order: Chamydiales


Family: Chlamydiaceae


Genus: Chlamydiales


Species:
___________________________________________I


I
Psifta affects cats, birds,
humans, and hoofed animals.
Includes the following human
serovars: D85711, D85712,
Cal-10, and human
m Pneumonititis.


Pecorum: affects cattle,
sheep and koala bears.


I
Phneumonmwae. affects equines and
humans. Includes N16 the only
equine serovar and the following
human serovars; PI-Parola,
S562B, 10L207, TW183.



TrFchomtis: affects humans and other
mammals. Includes the following
serovars that effect humans unless
indicated in parenthesis.


I MoPn (mouse),
SS45, R22 (pig),
Lymphogranuloma SFPD (hamster)
V2aereum

L1,L2,L2s L3


Urognia
I
B, D, Da, D,
Dv,E,F,G,H,I,
J, Ja, K


Content adapted from Tanner, Harris, & Pace, 1999; Schachter, 1999a; Stamm, 1999;
Morre et alt, 1998.

Figure 2. Chlamydiales Tree.


Trachoma
I
A,B, Ba, C








Two of four species in the genus Chlamydia, Chlamydia trachomatis and

Chlamydia pneumomae, prefer humans as their natural host. Please refer to Figure 2. The

other two species are C. psittaci and C. percorum that prefer birds and lower mammals

respectively. However there is cross-over between human, bird and mammalian strains.

Twenty-three serovars and perhaps eleven variants for Chlamydia trachomatis have been

isolated from human specimen by scientists (Schachter, 1999a; Morre et aL, 1998; Tanner,

Harris, & Pace, 1999; Stamm, 1999).


Developmental Cycle

Due to the unique developmental cycle, chlamydiae merited their own order

Chlamydiales, and a single family, Chlamydiaceae. In their unique growth cycle the

bacteria alternate between two morphologic forms. The elementary body (EB) is adapted

to the extracellular environment, while the reticulate body (RB) is specialized for

intracellular growth processes within the host. The metabolically inactive EB is the

infectious form and the RB the metabolically active or replicating form. There are distinct

steps in the chlamydiae developmental cycle. The first step is attachment of the elementary

body (the infectious particle) to the host cell. Second is entry into the cell. The reticulate

particle then undergoes morphologic changes, with intracellular replication and growth.

Further morphologic changes of the reticulate particle to elementary bodies, is followed in

the final step with release ofthe infectious particles (Schatcher, 1999a; Schatcher, 1995).

The steps are illustrated in Figure 3 below.

Wyrick (1998) provides a concise summary of the current body of information on the cell

biology of the chlamydiae gleaned from the scientific community in recent years. The EB








is metabolically inactive and resistant to most environmental challenges, but capable of

rapid attachment to the host ceil This attachment is generally held to be aided by some

mechanism that triggered adhesion with the assistance of the major outer membrane

protein, and generally was held to have occurred within an hour of infection. Newer

scientific knowledge suggests adhesion may instead be a parasite-specified phagocytosis,

receptor-mediated endocytosis in clarthrin-coated pits, pinocytosis in non-coated pits,

chlamydial heat shock protein70 interaction with ATP hydrolysis or movement assisted by

host microvilli (Raulston, Davis, Paul, & Wyrick, 1998; Patton, Cummings, Cosgrove,

Yvonne & Kuo, 1998; Wentworth, Judson, & Gilchrist, 1991). Most noteworthy is the

sheer speed with which the EB can enter the host. Electron microscope observation of the

'in vivo" uptake process has recently demonstrated that the EB are assisted by the

epithelial cell's mnicrovilli and that internalization is complete within five minutes, and has

reached the Golgi apparatus within ten minutes post infection (Patton et al, 1998). This

group of researchers suggests that the rapid uptake reflects the bacteria's need to reach

the host energy source, as it is incapable ofproducing energy on its own. Once inside the

host cell, a vacuole is formed to envelop the EB, where the EB remain throughout the

growth cycle. After a rapid initial fluctuation in pH, a triggered release oftyrosine

phosphoylation of the epithelial proteins follows and rearrangement of the chlamydiae's

cytoskeleton occurs. There is then an accumulation of F-actin and clathrin which it is

believed, aids to redistribute the EB to the peri-nuclear region of the host cell and the

resultant highly permeable vacuole formation (Wyrick, 1998; Schatcher, 1999a; Schatcher,

1995). The vacuole becomes what microbiologists term the "chlamydial inclusion body."

At this point the chlamydiae "prime" their host for obligate intracelhDular














Release at 48-72 hours of
as many as 100-1,000
elementary bodies.
1. Rupture
2. Fission
3. Disimagration




3.









Reorga14zat
18-24 hours


Initial host cell


t^


Host invasion at 5 minutes,


ion at
of


reticulate bodies to
elementary bodies;
some continue
binary fusion; one
can also observe
intermediate
forms.


Loss of rigid cytoskeleton
and formation into the
permeable inclusion body
with rapid relocation to
close proximity of Golgi
apparatus at 10 minutes.


Binary fusion of N
reticulate body at 8-
18 hours.


Maturation of elementary
body to reticulate body at
4-8 hours.


Content adapted from Schachter, 1999a, Wyrick, 1998; Schachter, 1995; Wentwrth, Judson & Gilchrist,
1991; Patton, Cummings, Cosgrove, Yvonne, & Kuo, 1998; Martin, 1990, Neeper, Patton, & Kuo, 1990,
Fedorko & Smith, 1991; Beatty, Morrison, & Byme, 1994.

Figure 3. The Developmental Cycle of Chlamydiae.


S.








growth and trigger maturation of the EB into RB. An obligate parasite, chamydiae utilize

the host cell's glycogen, metabolites and ATP in all steps of the developmental cycle. The

RB is somewhat larger and richer in RNA than the elementary body. The cycle then

progresses to binary fusion of the RB lasting from 20 to 24 hours. During this time

another unique activity can be observed: the fusion of multiple inclusions within the host

cel to create a single inclusion. After a period of reorganization, triggers that are unclear

cause many of the RB to mature into a new group of the smaller EBs in preparation of

extracellular exodus. Some RB will continue to divide. At this stage one can also observe

intermediate forms (IB) of the bacteria as well (Moulder, J. W., 1974, as cited in

Schachter, 1999a). Forty eight to seventy two hours after attachment to the host cell the

mature EB is ready for release to infect other epithelial cells. By this time the EBs will

occupy the entire cytoplasm of the host cell (Neeper, Patton, & Kuo, 1990). A single

inclusion body may release from 100 to more than 1,000 elementary bodies at maturity

(Martin, 1990). This release appears to occur in three modes, a volcanic like eruption,

fusion with plasma cell membrane, and a gradual disintegration of the cytoplasm, allowing

lateral invasion to near by cells. In short, scientists remain challenged by the study of the

chlamydiae's developmental cycle with more questions raised than answered in recent

years!

When protected by the vacuole, chlamydiae are able to resist the usual hostile

onslaughts of the host cell The intracelhilar form of Chamydia trachomatis is protected

from phagolysosomal fusion, by mechanisms not fully understood. The bacteria is sensitive

to iron limitations and shows enhanced uptake of some proteins, e.g., hsp60. The parasite

appears able to accept whatever phospholipids available in the host eukayotic cel. The








extracellular form of Chlamnydia trachomatis is inhibited by penicillins, but is not killed. In

this form it is sensitive to temperature, freezing, and dessication. Unlike C. psittaci that

can live for months in contaminated cat litter, C. trachomatis will die at 56C after 30

minutes. C trachomatis is also sensitive to common household disinfectants (Wyrick,

1998; Schachter, 1995; McCalarty & Hatch, 1998).


Pathophysiology and Pathogenesis

The clinical syndromes associated with Chlamydia trachomatis infection are well

recognized in the public health community. The pathogenesis of any of the infections

attributable to Chiamyda trachomatis is not well understood. Of the twenty-three

identified serovars, nine are predominant in the genital tract and in infantile pneumonia: D,

E, F, G, H, I, J, and K, with D, E, and F found most frequently worldwide. One, B, has

been identified in both ocular and genital sites (please refer to Figure 2.). Numerous

serovars and variants have only been identified in the last few years (Stephens et aL, 1998;

Stammi, 1999). Serovars in the C complex grouping (A, C, H, I, J, K) have been identified

as more likely to be associated with symptomatic rectal infection among homosexual

males (Boisvert, Koutsky, Suchland, & Stammn, 1999). It has been hypothesized that

severity of disease may be linked to the serovar. Some studies have supported this;

however, serovar F has often been identified in both less asymptomatic or less

inflammatory infection as well as in women with upper genital tract infection.

Squamocohnmnar epithelial cells are the primary target for non-LGV infections and

macrophages for LGV serovars. Initially, focal inflammation with infiltration of

polymorphonuclear neutrophils occurs. Mononuclear cell infiltration follows. Abundant








immune response occurs that includes circulating antibodies and cell-mediated responses

with both CD-4 and CD-8 T-helper cells. The CD-4 t-cells potentiate the immune

response. It appears resolution of the infection is supported by CD-8 cells (Brunham,

1999).

Three models predominate among the numerous models for pathogenesis under

consideration (Peeling & Brunham, 1996; Chlamydia Genome Project, 1999). There is a

considerable body of work to support consideration of delayed-type hypersensitivity

(Beatty, Morrison, & Bymrne, 1994; Rank, Sanders, & Patton, 1995 Schachter, 1999a). In

this model, re-infection with the same or different serovars leads to inflammation and

scarring of the affected mucous membrane. It is possible that the delayed-type

hypersensitivity (DTH) model may also result from reactivation of latent infection,

possibly triggered by altered levels of steroid hormones. Exogenous progesterone is used

in mouse model studies to enhance uptake of chlamydiae, and one study in ewes suggested

reactivation of latent chlamydial infection after either estrus or progesterone treatment

(Patton & Lichtenwalner, 1998). Others mention that both estrogen and progesterone

enhance the growth, survival, and ascent of Chlamydia trachmatis in female animal

models (Krettek, Ark, Chaisilwattana & Monit 1993). While it is unwise to assume

findings from animal studies are directly applicable to human pathogenesis of chlamydiae,

the role of steroids in DTH merits further investigation.

That latent infection can persist has been a controversial topic among researchers.

Some have provided compelling evidence that suggest persistence of a single strain over a

period of two to five years (Dean, Suchland, & Stamm, 1998). This group of researchers

used serial ompi genotyping on recurrent culture-positive specimens and ligase chain








reaction assays on selected intervening culture-negative specimens. In recent years other

researchers have used either culture or DNA amplification to examine persistent infection

concluding that persistence of infection is not supported (National Chlamydia Committee,

1999a). Hopefully, more conclusive evidence will be forthcoming in the future from

researchers.

A suggested alternate model is one of an inflammatory response mediated by

human heat-shock proteins and chlamydial heat-shock protein-60 or -70. Chlamydiae

evoke persistent host cell production of these pro-inflammatory cytokines. Strong

serologic levels of chsp-60 in severe pathology were observed by some groups and

reduced serologic response in other groups with milder pathology (Rasmussen et aL,

1997; Morrison, Lyng, & Caldwell, 1989; Patton et al, 1994). Witkin and colleagues

(1997) suggested that this same model may contribute to the reduced success with in vitro

fertilization and embroyo transfer observed among women with high levels of cervical IgA

antibodies to Chlamydia trachomatis. Other researchers question if the chlamydial heat

shock proteins are causally involved in chlamydial immunopathogenesis or merely markers

of persistent infection (Peeling & Brunham, 1996).

The third model for pathogenesis of Chlamydia trachomats is one of, genetic

susceptibility (Brunham, 1999; Peeling & Brunham, 1996). In this model the data

examined supported individual differences in immune responses. Those individuals with

weak cell-mediated and strong antibody response were susceptible to re-infection, slower

to resolve, and demonstrated more inflammation and disease. In contrast, those individuals

with a strong cell-mediated immune response and lower antibody response were less

susceptible to both the infection and disease. While the numerous models continue to be








investigated, the actual mechanism ofpathogenesis in humans has yet to be proven. There

is, however, mounting evidence that the bacteria can and do invade epithelial host cells at

different levels of the female reproductive tract, and at different times during the

reproductive cycle, e.g., pregnant and non-pregnant states. The role of persistent

chlamydial infection is also unclear in the process ofpathogenesis. Beatty and colleagues

(1994) reviewed the conflicting evidence for persistent infection and concluded that

further work following 'infected" culture negative persons should be conducted. Byrnme

(1996) also discussed the work to date on persistence and suggested that certain features

associated with in vivo growth of chlamydiae would further support some form of

persistent infection. These include the presence of abnormally large intracellular forms of

the organism, chlamydial nucleic acid in absence of culturable forms, immunologic

evidence of heightened reactivity to stress response proteins, and continuous presence of

chlamydial antigen. Bragina, Gomberg and Orlova (1998) reported morphological changes

in chlamydial bodies in persons with reported latent chlamydial infection. Others have

recently reported in vitro persistence of chlamydial antigens, and chlamydial particles while

studying antibiotic efficacy (Dreses-Werringloer, Jurgens, Zeidler, & Kohler, 1998).

Neeper, Patton, and Kuo (1990) provide cinematographic in vitro observation of

Chlamydia trachomatis growth cycles in primary cultures of human amniotic cells. Of

significant note, given the difficulty of culturing this bacteriumnn, were the sustained cycles

of infection that occurred, until all amnion epithelial cells in the monolayer had been

infected and destroyed. While in this study the amniotic epithelial cells were isolated from

the in vivo placental structure, the chlamydiae were capable of damaging the placental








tissues. The study does not conclusively demonstrate how the chlamydiae could actually

cross the intact membrane.

Neuer et al (1996) have suggested that the development of heat shock proteins

during mouse embryogenesis is a plausible explanation for differentiated expression of

heat shock proteins in early pregnancy using first-trimester decidua and failure of the

embryo to implant or survive. Gencay et at (1996) isolated Chlamydia trachmatis from

placental tissue. Intra-amniotic chlamydial infection can persist in the absence of clinical

symptoms, in the presence of intact membranes, and following apparent eradication of

chlamydiae (Askienazy-Elbhar, 1996; Morrison, 1996; Ghaem-Maghami, Hay, & Lewis,

1996; Koehler et al, 1996; Gencay et aL, 1997; Neeper, Patton & Kuo, 1990; Brunham,

Holmes, & Embree, 1990; Cmningham, 1995).


Laboratory Diagnosis ofChlamydial Infections

According to Lennette (1995) there are three approaches to laboratory diagnosis

of infections: 1) direct detection of the organism, 2) cultivation of the organism in a

suitable host and 3) use of serology to obtain evidence of recent infection. Direct

microscopic examination of the live organism that causes the infection, direct fluorescent

antibody technique, and detection of nucleic acids through hybridization or amplification

are acceptable technologies for direct detection of the organism. An example of

microscopic examination for a sexually transmitted disease pathogen is darkfield

microscopy of freshly collected specimens from moist or dry lesions and lymph nodes for

Treponemapallmidwn subspecies pallidum or Direct Fluorecent Antibody (DFA-TP)

technique for body fluids or lesion exudate (Larsoun, Hunter, & McGrew, 1991). Other








direct visualization examples include gram stain for Neisseria gonorrhoeae and saline or

potassium hydroxide microscopy for bacteria vaginosis and candidiasis (Lowe & Saxe,

1999). Many commercial enzyme inmnmoassay tests for chlamydial and gonorrheal

antigens, and direct fluorescent antibody for visualization of chlamydia elementary bodies

have been available since the 1980s for wide spread screening programs. (Chemesky,

1999; Ehret & Judson, 1991; Fedorko & Smith, 1991). These tests have a sensitivity of

50% to 75% and specificity of 95% to 100% (Pate, Dixon, Hardy, Crosby, & Hook,

1998).

Highly sensitive nucleic acid amplification technology has become available more

recently. This method utilizes either target amplification, probe-amplification, or signal

amplification to detect minute numbers of organisms in a specimen. These tests are vastly

superior overall to culture or any other technology now available with sensitivity ranges of

95% to 100% and 99% to 100% specificity, (Kacena et aL, 1998; Everett, Honmung, &

Anderson, 1999; Quinn et aL, 1996b). Two other studies with LCRL show a similar range

of sensitivity. One conducted in France including women ofboth high (STD clinic) and

low risk (prenatal clinic) for chlamydial infection found an overall sensitivity of 95.2% and

specificity of 99.6% (de Barbeyrac, Rodriquez, Dutilh, le Roux, & Bebear, 1995). The

second study conducted in Florida among subjects from obstetric and gynecological clinics

reported the sensitivity as 97.6% and the specificity of 100% (Davis, Riley, Peters, &

Rand, 1998).

Pooling of chlamydia specimens will reduce the sensitivity slightly from 100% to

98.4%, but not for gonorrhea specimens as reported by researchers (Kacena et al.,1999;

Kacena, Quinn, Hartman, Quinn, & Gaydos, 1999). Pooling can provide even with minor








decreases in sensitivity a significant cost savings of 37% to 46% with pooled sensitivity of

92.8% in pools of four urines and 97.9% in pools of 8 urines (Krepel et aL, 1999). Gaydos

and colleagues (1998) reported lower sensitivity (88.6%) using amplified testing on urine

specimens. Unfortunately, amplified tests remain much more costly than other direct

detection methods. Direct detection offers the advantage of rapid results when compared

to cultivation in culture mediums. Other advantages are generally affordable cost and high

volume capabilities, important considerations for any public health screening program. The

disadvantage of the direct detection approach is variable sensitivity and specificity between

testing technologies and manufactured products, as well as variable sensitivity and

specificity among groups with different prevalence, a phenomenon common to all

screening tests.

Cultivation of the organism in a suitable host is the standard by which all other

detection methods are compared, especially for medical-legal documentation. This is true

for Chlamydia trachomatis, even though cell culture is reported to range from 50% to

90% sensitive (Fedorko & Smith, 1991; Newhall et al., 1999). The range of sensitivity is a

function of prevalence in the population, laboratory expertise, quality of specimen

collection and most often, of specimen transportation. Specimens collected to identify

Chlamydia trachomatis must be inoculated onto cycloheximide-treated McCoy cells. The

specimens should be refrigerated and processed within 48 hours of collection; if the

interval will be longer then the specimens should be frozen at 60 C (Schachter, 1995).

These parameters and the bacteria's sensitivity to heat exposure often adversely effect the

viability of organisms for cell culture during the transportation interval These factors








combined with the cost of culture, have contributed to the widespread popularity of the

direct detection methods commercially available since the 1980's.

Numerous forms of serologic tests have been useful for the detection of sexually

transmitted infections. However, only T. pallidum, C. trachomatis, human

immunodeficiency virus (HIV), hepatitis B virus (HBV), and herpes simplex virus (HSV)

have an adequate immune response in current infection for serologic testing (Chernesky,

1999; Chemesky et al, 1998). With these responses there is also significant variability,

reducing the reliability of this technique for laboratory diagnosis and restricting its

application to specific situations. In the case of Chlamydia trachomatis the antibody

response elicited during infection may be long lived, therefore serology for identification

of lower tract syndromes has not been successful (Black, 1997, 1998). Serology is useful

in diagnosis of infant chlamydial pneumonia and HIV, HBV, and HSV. Serology has been

invaluable in the epidenmiologic study of chlamydial infections in different populations

(Numazaki, 1998; Gencay et aL, 1995; Harrison et aL, 1983; Numazaldki & Chliba, 1996;

Numazaki, Kusaka, & Chiba, 1996; Fejgin et at, 1997; Cohen, Tenenbaum, Michaeli,

Beyth, & Sarov, 1990). First used as a screening test in diagnosis of non-lesion syphilis

before World War 1, serology has proven to be very effective in the control of this STD

(Brandt, 1985; Pynchon, 1964). However, even with positive serology for T pallidum in

an individual for whom a darkfield examination or direct antibody test is not available,

confirmation should be sought with the use of a treponemal test technique to identify false

positives (Chemrnesky, 1999; CDC, 1998b).

In populations with low to moderate prevalence, as observed in the study sample,

the sensitivity of the non-culture tests range from 50% to 96% and the specificity from 93








to 99% (Dinh & Martens, 1993; Stamm, 1999; Newhall et al, 1999). The direct detection,

non-culture test employed to diagnose Chlamydia trachomatis genital infections, Gen-

Probe PACE2C, was used in this study. The test manufacturer's published chlamydia

sensitivity ranges from 92.5% among those with a high (17.8%) positivity rate to 94.3%

among those with a low (4.1%) positivity rate (Gen-Probe Incorporated, 1994a).

Early studies conducted on persons who sought care in Florida county health

departments and elsewhere report a sensitivity of 96.4% for the Gen-Probe PACE2C

combination assay among asymptomatic and symptomatic females and males. The

prevalence ranged from 6.6% to 9.3% for chlamydia and from 6.6% to 56.5% for

gonorrhea, with a combined specificity in this same group of 98.0% (Hale, Melton,

Pawlowicz, Halstead & Wright, 1995; Hale, Melton, Lewis, & Willis, 1993; Schwebke &

Zajackowski, 1996). This technology may be less sensitive with male urethral specimens.

Kluytmans et aL (1991) reported a sensitivity of 70% among a male population with a

culture prevalence of 13.2%. In this same group the female sensitivity was 92.7% and

prevalence 8.6%.

More recent studies conducted with Gen-Probe PACE2C compared with DNA

amplification tests and other non-culture tests suggest that earlier studies may have over

estimated the sensitivity of this nucleic acid hybridization test (Newhail et aL, 1999; Wylie,

1998). Wylie et aL(1998) reported a prevalence of 10.4% and sensitivity of 79.3% among

a population offemales residing in Manitoba Canada. Newhall et al. (1999) found a

prevalence of 3.9% and sensitivity of 75.3% and 75.3% respectively, among populations

of family planning patients from Washington and Oregon.








Gen-Probe PACE2C employs the principle of nucleic acid hybridization method.

The concept behind this technology is based on the re-pairing of specific nucleotide bases

that compose the ribonucleic acid (Foorghani & Erdman, 1995). The double-stranded

target ribosomal ribomnucleic acid (rRNA) of the chlamydia or gonorrhea organisms is

dissociated and re-paired with a chemiluminescent single strand probe which can be read

by the testing equipment. This process is based on a biological in vivo amplification of

rRNA. Many more copies of rRNA (5,000 to 10,000) exist in an individual cell as

compared to a single deoxynucleic acid (DNA) strand. This is a different testing

methodology from DNA amplification utilized in PCR, LCR, TMA, and SDA testing. As

with DNA amplification, rRNA hybridization increases the likelihood that the chlamydia or

gonorrhea organisms will be identified in the specimen as compared to some other

technologies, however the sensitivity does not approach that of amplification.


Confounding Factors and Quality of STD Specimens Submitted for Testing.

Specimens submitted for chlamydia, or other STD testing, may be adversely

affected by any number of clinician-controlled behaviors, laboratory management,

transportation interval, and patient-related issues. Among the many variables controlled by

the level of clinician skills and knowledge are: choice of collection implements, the

presence of excessive blood, mucous, pus or exudate, exfoliated cells, vaginal secretions,

debris, fibers, and lubricants included with the specimenss.

Other factors confounding specimen quality are the availability of supplies in the

clinic, types of instruments and implements as well as their consistent supply. This issue is

one faced by all providers, public health as well as private (Pachciarz et al, 1992; Steiner,








1989). For example, unavailability of'large drum' swabs reduce the ease with which a

clinician can adequately and efficiently clean the cervix of excess exudate or blood. In one

study the use of the cytobrush to collect chlamydial specimens improved the rate of

adequate endocervical specimens but not the sensitivity of the enzyme-linked

immunosorbent assay used (Kellog, Seiple, Klinedinst, & Levisky, 1992). In contrast,

Moncada and colleagues (1989) observed improved sensitivity for both direct flourescent-

antibody and enzyme-linked immunosorbent assays with use of the cytobrush. Another

group of researchers who compared swab type and storage temperature reported that

calcium alginate swabs were toxic to Chlamnydia trachomatis and herpes simplex virus and

that cotton on wood appeared to be inhibitory to chlamydiae (Mahony & Chemesky,

1985). The authors also cite others who reported that wooden shafts were toxic to

Ureaplasma urealyticum and Neisseria gonorrhoeae (Mardh & Zeberg, 1981 as cited in

Mahony & Chemesky, 1985). Their concluding recommendation was to use cotton, rayon

or dacron tips on aluminum or plastic shafts to increase the viability of specimens for

culture.

Training and skills of those sampling the cervix is variable and may affect the

quality of the specimen collected. The timing and force with which a swab is rotated

within the cervical os may dictate the likelihood of retrieval of adequate numbers of

columnar cells, and adversely impact on a positive finding for direct detection tests with

lower sensitivity. Because Chlamydiae are obligate intracellular parasites, one must collect

the appropriate host cells, columnar epithelial cells located in the cervical os, or at the

transition zone. Additionally, the clinician needs to apply adequate pressure and vigorous

swabbing to obtain the infected cells (Schachter, 1990).








Contact of the specimen collection swab with the vaginal mucosa on exit from the

vagina may introduce confounding inhibitors that interfere with testing equipment and

create false readings with DNA amplified technologies. Other inhibitors associated with

reduced sensitivity in DNA amplification testing include excessive cervical mucous, talc

from latex gloves, and residual urine remaining after DNA purification (National

Chlamydia Committee, 1999b).

Patient related variables such as age, recent coitus, and topical medications,

lubricants, or spermicides are also potential confounding factors that may adversely affect

the quality of the specimen submitted for testing (Bauman, 1993; U.S. Department of

Health and Human Services, 1989).

After collection, the actual management of the specimen can adversely affect the

quality and the findings. If the recommended temperature is not maintained while in

storage prior to transport or during transport the specimen can deteriorate significantly.

For example, failure to maintain chlamydial specimens for culture under refrigeration or

freezing will reduce viability of the bacteria and the likelihood of a positive culture result

and failure to incubate gonorrhea culture specimens at the correct temperature and period

of time will reduce their vigor. Submission of small amounts of blood with specimens does

not interfere with hybridization test performance; however, grossly bloody specimens may

interfere with assay performance (Gen-Probe Incorporated, 1994a). Vaginal secretions

and excessive mucopus have been found to interfere with different screening tests and

assay performance, including Gen-Probe (Cehim et al, 1994).








Standards on Gen-Probe PACE2C Testing Techniques Within Florida

Testing standards in the Office of Laboratory Services require that all female

specimens are first screened with the PACE2C System, a combination chlamydial and

gonococcal nucleic acid hybridization technique. The combination assay allows rapid dual

screening for the presence of either Chlamydia trachwmatis or Neisseria gonorrhea.

While this first assay does not distinguish between which organisms are present, it is a

cost-effective labor reducing approach in populations with lower prevalence, e.g., prenatal

clinics compared to STD clinics (Hale, Melton, Pawlowicz, Halstead, & Wright, 1995).

All specimens screening positive for the presence of an infection are then re-tested using

both the PACE2 Chiamydia and PACE2 Gonorrhea assays. Additionally, all high negative

specimens and low positive specimens are re-screened (Farthing, Brumback, Morris, &

Wright, 1995). This involves a two step process. The first is a repeat ofthe PACE2 assay

utilizing the chemiluminescent labeled DNA probe specific first for chlamydia, followed by

that for gonorrhea. Next the specimen is tested using the Probe Competition Assay (PCA)

with reagents that winl compete for the target binding sites to form stable DNA-RNA

hybrids. A reduction in the signal generated will indicate the specimen contains Chkamydia

trachomatis or Neisseria gonorrhea rRNA contingent on the assay used (Gen-Probe

Incorporated, 1994a). The PCA fimnctions as a confirmatory test for questionable results as

well as a percentage of all positive findings, an appropriate standard when misdiagnosis of

either sexually transmitted infection could lead to psychological anguish or legal

ramifications for the patient and/or their partner. Those specimens that originally tested as

high negative or low positives but on retesting tested positive or negative respectively, are








reported as 'indeterminate" accompanied by the recommendation that the clinician obtain

a follow-up specimen for re-testing if the patient has not already been treated for infection.

Test results are calculated based on the difference between the response in relative

light units (RLU) recorded from the specimen and the mean of the negative reference

readings (Gen-Probe Incorporated, 1994a). Before testing each day, equipment is re-

calibrated and cut-off ranges for RLU reading are set.

Related urogenital organisms may be present concomitantly with either chlamydia

or gonorrhea. Among these are Chlamydia psittaci, Ureplasma ureatlyticum, Gardenella

vaginalis, and Candida albicans. Analytical specificity of Gen-Probe indicates these

organisms do not cross-react with Chlamydia trachomatis or Neiserria gonorrheae

probes during testing (Gen-Probe Incorporated, 1994b).


Risk Factors for Low Birth Weight

Many variables have been reported in the volumes of literature on risk factors

associated with LBW. Investigators have studied the associations between birth outcomes

and malnutrition, smoking, reduced or absent social support, employment, violence, work,

stress, poverty, age and education, high and chronic stress, low-socioeconomic status,

utilization of and access to prenatal care, member of minority ethnic or racial group, drug

and alcohol use and infectious diseases. Much of this work has been focused on

identification of markers for pre-term birth or low birth weight. Less is known about the

role ofpsychosocial factors and the comparison of these variables for term low birth

weight and pre-term outcomes. Some key findings on a number of the potential

independent variables are summarized below.








Contribution of psycho-social and behavioral factors. Psychosocial stress was

examined prospectively by researchers to identify any associations with LBW in a low-

income urban population (Orr, James, Miller, & Barakat, 1996). The researchers used

logistic regression with low, moderate, and high stress dichotomous dependent variables

controlling for exposure to different stressors. The independent stressors included among

others were chronic financial or marital problems, death, divorce, housing, and

employment. Scores were not associated with demographic variables such as race, marital

status or educational level For all women, exposure to stressors was closely associated

with other clinical and behavioral risks for LBW. There were some different and some

similar associations with low birth weight for blacks and whites. Significant for black

women were smoking, hypertension, hospitalization during pregnancy, low pre-pregnancy

weight, prior pre-term birth, and exposure to stressors. Significant for white women were

smoking, drug use, hypertension, hospitalization during pregnancy, and prior pre-term

birth.

In contrast, another group of researchers reported finding no association between

psychological distress and birth weight for gestational age (Heddegaard, Henikson,

Sabroe, & Secher, 1996). This prospective population-based study collected measures of

psychological distress at the 16e and the 30e week of pregnancy by questionnaires among

Danish women with singleton pregnancies. Dunkel-Schetter (1998) reviewed numerous

studies conducted with colleagues to highlight their findings and possible mechanisms that

may contribute to interactive processes between pre-term delivery, anxiety, stress, and

stress hormones.








Copper and colleagues (1996) examined stress through measurement of anxiety,

self-esteem, mastery, depression, and stress. They reported that stress was associated with

PTL, SGA, and LBW after adjustment for maternal behavioral and demographic

characteristics. Among black women, this was even more significantly associated. Other

researchers identified maternal residence in public housing, poverty, and feelings of

helplessness with significant decreases in mean birth weight (Shiono et aL, 1997).

The role of maternal employment on LBW and gestation is also conflicting.

However two studies conducted with women in other countries suggest that intrauterine

growth restriction and PTL may be affected by moderate to heavy physical work effort

(Spinillo et at, 1996; Launer, Viar, Kestler, & Onis, 1990).

Smoking during pregnancy has been found to be significantly associated with

LBW, TLBW, and PTLBW. Increased risks ranges from OR 2.1 to OR 2.8 and appear to

be dose related (Cnattingius & Haglund, 1997; Olsen, 1992; Sexton & Hebel, 1984). One

Swedish study examined data for births from 1983 to 1992 and reported a 'true' decrease

in smoking during pregnancy and reduction in the attributable risk for SGA infants

(Cnattingius & Hagluhmd, 1997). The highest odds ratio, 2.8, was observed each year

among women smoking more than ten cigarettes per day.

Another area of study related to smoking and potential LBW is the differences

between race and ethnic groups and tobacco use. Among those women who quit smoking

sometime during their pregnancy, more women were of white race/ethnicity (12.7%)

compared to 4.3% of Hispanic race/ethnicity (Ruggiero & Groot, 1998). Among those

women identified as never having smoked the percent was inversely related 41.5% for

women of white race/ethnicity and 81.6% of Hispanic race/etmhnicity. Ahijevych and








Gillespie (1997) studied nicotine dependence among black and white women and reported

differences in plasma cotinine to cigarette ratios. Black women scored higher on plasma

cotinine levels; cotinine per cigarette ratio and carbon monoxide boost suggest ethnic

differences in nicotine metabolism. They also refer to information from other studies that

indicated black women sustained "greater lunhmg damage and less lung function recovery

following cessation than their white counterparts." These potential effects of smoking

among black women may potentiate the adverse impact on pregnancy and birth weight and

merit additional study to better understand the relationship of this risk factor.

Contribution of physiological and medical care factors. Weight gain has been

associated with fetal growth and consequent birth weight ranges (Abrams & Laros, 1986;

Seidman, Ever-Hadani, & Gale, 1989). Schieve, CogswelL and Scanlon (1999) examined

associations between weight gain per week of pregnancy and net weight gain per week of

pregnancy in a low-income urban population. Their findings suggest an association

between both low and high weight gain and PTL. They concluded that women with a

weekly weight gain at or near the Institute of Medicine guidelines for their respective body

mass index had the lowest risk of pre-term delivery. Abrams and Parker (1990) who

examined only term pregnancy outcomes reported that a wider range of maternal weight

gain than recommended in earlier published guidelines, was associated with good

outcomes. They also found no significance between maternal weight gain and SGA

infants.

Lumey (1998) examined the effects of under nutrition in pregnancy among infants

born during 1944-1946 in the Netherlands and hypothesized that potential biological

compensatory mechanisms increase placental growth in conditions of under nutrition. The








placental weight was compared to birth weight, and the average national maternal food

ration during the war years was used to estimate under nutrition. Among infants exposed

to the risk factor in the third trimester, mean birthweight decreased. No change in birth

weight was observed among infants exposed in the first trimester, but there was an

increase in placental weight and index to the birth weight. The author also references other

studies that have reported an increase in placental index in the presence of anemia and

maternal smoking. Another study that examined Women Infant and Children (WIC)

program enrollment identified a small but significant protective odds ratio for small for

gestational age the longer that a women was enrolled in the program (Ahluiwalia, Hogan,

Grummer-Strawn, Colville, & Peterson, 1998).

Hickey, Cliver, Goldenberg, McNeal, and Hoffman (1997) examined risk factors

that might contribute to low prenatal weight gain. They studied non-obese low-income

women and controlled for socio-demographic lifestyle and reproductive characteristics.

Three characteristics were associated with significant odds of low prenatal weight gain

among women of black race: a mistimed or unwanted pregnancy (OR 2.0), more than one

preschool child at home (OR 2.0), and not using her own car for errands (OR 2.1).

Among women of white race only, working more than 40 hours per week was associated

with low prenatal weight gain (OR 9.1).

Many different measures have appeared in the literature to define and assess the

adequacy of prenatal care. Adequacy of care or utilization is then examined along with

other variables for its association with LBW. Overall most of these measures recommend

initiation into care during the first trimester and then some pro-set number of visits with

consideration for length of gestation (Alexander & Kotelchuck, 1996). These measures








overall do not measure content, capture gaps in visits, or adequately consider high-risk

pregnancy visit schedules (Stringer, 1998). The inadequacy ofthe different indices to

accurately quantify adequacy is highlighted in the numerous studies that have compared

the different measures to the same sample population. Alexander and Kotelchuck applied

five measures to data files containing 169,082 singleton births. The proportion of cases

assigned to each utilization category (adequate, inadequate, etc.) ranged from 34% to

58% for adequate care, 9% to 20% for inadequate care, and 7% to 27% for intensive

utilization.

The Kessner index was applied in a North Carolina study that compared infant

birth weight for women receiving their care at the health departments or from other

providers who accepted Medicaid (Buescher, Smith, Holliday, & Levine, 1987). Medicaid

women who received care from other providers were at twice the risk of having a LBW

infant compared to those who received their care at the health department. Augustyn and

Maiman (1994) utilized the 1988 Institute of Medicine indices to examine psychological

and sociological barriers to prenatal care from the reported literature. Another research

group examined the national changing pattern of prenatal care utilization with four of the

published indices (Kogan, Martin, Alexander, Kotelchuck, Ventura, & Frigoletto, 1998).

Markedly different trends were produced with the different indices. Virtually no change in

utilization for adequate or intensive care was reported using the IOM index, while an

increasing trend was noted for more adequate and intensive prenatal care utilization was

reported with the R-GINDEX and APNCU index. Differing patterns of utilization and

trimester of entry for by teenagers ranged from 2.9% to 16.3% and 12.6%respectively.








Marked differences were also noted for utilization with multiple gestations as reported by

the different indices ranging from a -13% to 23%.

Perloff and Jaffee (1997) compared two measures to examine the utilization of

prenatal care in New York City. The most interesting finding they reported was the

marked differences in sample characteristics that the two indices produced. The magnitude

of risk for inadequate care among blacks, teens, those women not completing high school,

and unmarried women is significantly increased with the use of the APNCUI indices.

Kogan, Alexander, Kotelchuck and Nagey (1994) looked at the content of prenatal

care and its association with LBW. They utilized the Kessner Index to measure adequacy

of prenatal care utilization and controlled for other risk factors such as age, education,

employment status, smoking, etc, and examined interaction terms in their logistic

regression models. Women in this study who did not report receiving all types of advice

recommended by the Expert Panel on the Content of Prenatal Care were more likely to

have a LBW infant (OR 1.38). The authors found no differences between women who

reported that they received all the recommended initial prenatal care procedures, and those

who reported not to have received all prenatal care procedures With the discrepancies

observed in the above reviews of the different indices the risk associated between LBW

and '"inadequate care" in this and other studies must be interpreted with caution.

Very young age appears to be associated in some studies with LBW and also late

initiation into prenatal care. Higher rates of LBW have also been observed for women

over forty. For adolescents aged 15-19 the rate of LBW in 1997 nationally was 13.6%,

and for women over forty, the rate was 10%, while the overall rate was 7.5% (Ventura,

Martin, Curtin, & Mathews, 1998). Among all women nationally, the percent that entered








prenatal care in the first trimester was 82.5% while only 68.1% ofwomen aged 15-19

entered care in the first trimester.

Adolescents are two times as likely to deliver a LBW infant than are adults

(Ventura, Martin, Curtin, & Mathews, 1998). According to Helerstedt, Pirie and

Alexander (1995) parity of the adolescent may also contribute to this observed difference.

They reported a difference in LBW rates between primapara (6.5%) and multipara (7.6%)

adolescent mothers in their study of adolescent parity and infant mortality. Roth and

colleagues (1998) reviewed the literature on young maternal age and the incidence of

LBW infants. They noted that the published studies have examined this association from

numerous perspectives. One association is young gynecological age, and possible

restricted blood supply to the cervix, that in turn may predispose the young female to

infections that contribute to preterm delivery. A second theory put forth is nutritional

competition for nutrients between the mother and developing fetus. A third theory

suggests that combined psychosocial behaviors and conditions like concealment, and

accompanying reduced food intake, delayed entry into prenatal care and poverty are the

real risk factors, not age. The authors also cite work done by Geronimus to explore the

role of race in adolescent LBW rates and noted that the ratio of black LBW to white LBW

for 15-19 year olds was 1.8. Geronimus (as cited in Roth, 1998) theorized that it is a

lifetime of exposure to racial stress that contributes to the development of "hypetension, a

precipitating factor" in pre-term labor and delivery, resulting in LBW.

Swedish researchers examined the births of younger and older women and

reported that birth to young women was a social problem, not associated with LBW. The

adolescent rate of LBW at 5.4% was better than the overall for women between the ages









of 35 and 49 whose rates were from 9.6% to 8.9% (Hemminki & Gissler, 1996). Their

findings in a different population are consistent with much of the epidemiologic data in this

country and suggest that the resulting social stigmata and subsequent increased risk for

lifetime poverty are greater risk factors for the adolescent compared to the older women

for whom the low birth weight event is a greater risk. Lee and colleagues (1988) examined

birth records from Illinois for the years between 1980 and 1984. After controlling for race,

education, parity, prenatal care, and marital status they concluded that the adjusted risk for

low birth weight at term is lowest among teens and increases with advancing maternal age.

Childbearing at an older age in this country is associated with higher rates of low

birth weight. For 1996, 8.1% ofbirths to women aged 35-39 were less than 2,500 grams,

9.5% to women aged 40-44 years, and 14.9% to women 45-49 years of age (Ventura,

Martin, Curtin, & Mathews, 1998). The rate for women of black race/ethnicity is even

more pronounced at advanced childbearing ages: 16% for women 35-39 years, 18.4% for

women aged 40-44, and 18.2% for those 45-49 years. Lee (1988, as cited by Committee

on Unintended Pregnancy, 1995) suggests that this association may be linked to biologic

aging of maternal tissues and systems, or the accumulative effects of diseases e.g.,

hypertension, diabetes.

The epidemiology ofLBW and the literature suggests that black race/ethnicity is

disparately associated with LBW, as well as PTLBW and PROM. Vrji and Cottington

(1991) observed that black women experienced a significant risk for PTL, (adjusted OR

1.56). Others reported an odds ratio of 2.1 for PTL among both black and HiEspanic

women (Berkowitz, Blackmore-Prince, Lapinski, & Savitz, 1998). Collins and David

(1990) examined race and the differential effect of income, education, marital status, and








age on LBW. The risk of LBW remained twice that of white women across all age groups,

education, or income strata.

Others have reported that black race/ethnicity is not a risk for LBW when the

mother is foreign born and in fact is protective when compared with black United States

born counterparts. Cabral and colleagues (1990) observed that foreign-bomrn black women

were more likely to be older, married, better educated, have better pre-pregnancy weight

for height ratios and adequate prenatal care. Their reported adjusted odds ratio for having

a low birth weight infant was 0.81; however, the confidence interval included 1.0 negating

the association. Others also suggested that there is a protective effect from foreign birth

status with an odds ratio of 0.88 and 0.77 among Caribbean and African-born black

women, with the confidence intervals all below 1.0 (Fang, Madhavan, & Alderman, 1999).

Collins and David (1993) examined biracial infants to determine the role of black

to white disparity in birthweight. When all variables were entered into logistic regression

to control for income, education, marital status, etc, the adjusted odds ratio of LBW for

biracial infants born to black mothers and white fathers was 1.4 compared to the biracial

infants born to white mothers and black fathers. Biracial infants born to black women also

had an increased likelihood of prematurity and SGA, OR 1.6 and 1.7 respectively.

Rural residence has been suggested by some as an adverse situation for access into

prenatal care and needed services, with subsequent poor outcomes. Researchers in the

northwest examined linked birth records and hospital discharge abstracts stratified by

insurance source to examine the effects of poor local access on the risk of having a 'non-

normal' infant (Nesbitt, Larson, Rosenblatt, & Hart, 1997). They reported women with

poor access expereinced an increased risk of delivering a non-normal neonate (LBW,








PTLBW and increased associated costs). They also noted that women with private

insurance were more likely to have higher costs and longer stays overall

In contrast, Larson, Hart and Rosenblatt (1997) found no association with

residence in a non-metropolitan area for LBW or VLBW. They did observe an adverse

effect for neonatal mortality and post-neonatal mortality. However, on logistic regression

non-metropolitan residence was not associated with either LBW or neonatal mortality.

Alexy, Nichols, Heverly, and Garzon (1997) reported that rural or urban residence did not

predict LBW. They found race, weight gain, number of total prenatal care visits, and

adequacy of diet resulted in stronger associations to predict LBW. 0' Campo and

colleagues (1997) conducted muti-level modeling to examine macro (census tract) and

individual risk factors. They noted all individual level risk factors for LBW had a different

effect dependent on the neighborhood of residence. They suggested that housing, crime

and unemployment modify the relationship of urban or rural residence to LBW.

Researchers examined the inter-pregnancy intervals (IPI) of small for gestational

age (SGA) and pre-term births among a North Carolina population of blacks and whites

(Shultz, Amrndt, Olshan, Martin, & Royce, 1998). Three categories of IPI were created: 0-

3 months, 4-12 months, and 13-24 months. Those with IPI of greater than 24 months

were excluded, due to the possibility of sub-fecundity and potential increased risk for low

birth weight. Race specific logistic models were used and population attributable risks

calculated. Evaluation of single month intervals indicated that the odds ratio for SGA

infants was elevated for each until 10-12 months, and decreased with increasing IPI. There

was no consistent pattern for pre-term birth associations using the single month

incremental analysis. Overall they found a moderate association (OR 1.6) between SGA









and IPI of 0-3 months. No significant association was observed for the IPI of 4 to 24

months.

Prior LBW events and prior pre-term deliveries have been reported as significantly

associated with an increased risk for subsequent LBW and PTL events. The birth record

and the Healthy Start prenatal screen both contain fields to capture information related to

prior poor birth outcomes. Hulsey and others (1998) reported a 2.8 times increased risk

for a subsequent pregnancy with PTL, following an initial pre-term delivery. The authors

calculated a population attributable risk that attributes 22.5% of second pre-term

deliveries to having had one previously. Black women experienced an overall greater rate

of pro-term deliveries, but if a white woman delivered prematurely on the first pregnancy

she was at a 4.5 times increased risk compared to black women with 2.5 increased risk.

Another risk for poor outcomes may be the role of the father. One study, reported

that among women who changed partners after their first delivery before 34 weeks, a 33%

reduction in the risk of a subsequent early pre-term delivery was observed compared with

those who did not change partners (Li, 1999). Among women who had initially delivered

at gestation over 36 weeks, changing partners increased their risks of a subsequent pre-

term by 16%. Among women between 34 and 36 weeks no effect was observed with the

changing of partners. The weight of the father may also contribute to increased risk of low

birth weight delivery for his partner. Klebanoffand others (1998) studied the offspring of

an historic Danish cohort combining data from birth registries, military records and

midwifery records. They found a significant association between paternal birth weight and

the subsequent birth weight of their offspring, independent of the maternal birth weight.

Other researchers have demonstrated an association between a woman's birth weight and








the development ofpre-eclampsia during their own pregnancies as teenagers or young

adults (limnnes, Marshall, Byers, & Calonge, 1999).

Contribution of sexually transmitted infections. Dunkel-Schetter (1998) has

suggested the possibility that stress increases risky sexual behavior during pregnancy, with

reduced prenatal care utilization for the detection of infection. However, she offers no

evidence to support this concept. Other literature reports ample associations between intra

and inter-uterine infection, low birth weight, spontaneous pre-term labor/delivery and the

more commonly known sexually transmitted infections like gonorrhea, syphilis, herpes,

trichomonas, and more recently, chlamydia and human immunodeficiency virus. Less

commonly known are other diseases often associated with sexually active women, but

whose modes of transmission are even less well understood than the historical STDs.

These include group B Streptococcus, hepatitis B and C, cytomegalovirus, and the many

organisms associated with bacterial vaginosis. The more well known adverse pregnancy

events associated with STDs include stillbirth, perinatal death, and mental retardation,

attributable to early syphilis, herpes, cystomegalovirus, and group B Streptococcus,

(Goldenberg, Andrews, Yuan, Mackay, & St, Louis, 1999).

Eschenbach (1998) suggests that any amniotic infection is a fetal infection, and

consequently may have a role in causality of pre-term delivery before 28 weeks. Other

recent studies with chlamydia that have examined pathogenesis of the fetal, and maternal

tissues would support such a hypothesis and deserve more consideration.

Not much research has been conducted to examine the direct association between

low birth weight and each sexually transmitted infection while controlling for other

confounding variables. Researchers have prospectively evaluated the role of Trichomonas








vaginalis in low birth weight in a large multi-center study among an ethnically diverse

population (Cotch et al., 1991, 1997). They reported at a 95% confidence interval that

pregnant women infected with the protozoan were significantly more likely to deliver a

low birth weight infant, and to have a pre-term birth weight infant (OR 1.3, and 1.4, p <

.01). Also, infection with Trichomonas vaginalis accounted for a disproportionate share

of low birth weight deliveries among blacks as compared to whites or HIispanics in this

study. Earlier studies found no association between the pathogen and low birth weight

(Mason & Brown, 1980; Ross & Middlekoop, 1983, as cited in Wolner-Hanssen, 1999).

Trichomonas vaginalis is more likely to be found in the squamous epithelium, but

evidence has been reported of infection in desquamated cells from human amniotic

membranes (Wolner-Hanssen, 1999).

Syphilis was the earliest recognized maternal sexually transmitted infection to be

associated with adverse outcomes. One study published in 1917 and another in 1951

identified a transmission rate during pregnancy of 60% to 70% (Schultz, Schulte, &

Berman, 1992). While sexual transmission is believed to cease after four years of infection,

the possibility of transmission of the spirochete to the fetus by blood-borne transplacental

infection is more enduring as demonstrated with a 25% risk of fetal infection during early

and 12% during late syphilis (Ingraham, 1951, as cited in Radolf, Sanchez, Schulz, &

Murphy, 1999). Many studies have identified the strong association between stillbirth and

spontaneous abortionthe most common sequelae, that occurs most often in the 2wd and

early 3"' trimesters (Radolf Sanchez, Schulz, & Murphy, 1999). No literature is available

that suggest an association between syphilis and low birth weight while controlling for

other confounding variables.








Herpes simplex virus is not associated with low birth weight, and generally is

believed to be transmitted intra-partum (Stagno & Whitley, 1999). It is associated with

pre-term labor and spontaneous abortion and both primary and recurrent infection can

cause fetal infection in utero. The sequelae that can accompany infection range from skin

vesicles, blindness, disseminated infection, and long term neurological impairment and

most often are lethal The authors ofthe NIAID Collaborative Antiviral Study (as cited in

Stagno & Whitley, 1999) reported in their data that 33% of those with disseminated

infection, 23% of those with central nervous system infection, and 24% of those with skin,

eye or mouth infection were delivered before 36 weeks.

Intra pregnancy infection with Neisseria gonorrhoeae has been studied by several

groups as reported in Gutman (1999) and Morse and Beck-Saque (1999). The rates for

premature delivery were between 13% and 67%; however, no mention is made in CGutman

of the infants' birth weights or association with term low birth weight, or small for

gestational age infants. Other adverse outcomes reported, include spontaneous abortion,

perinatal death, perinatal distress, stillbirth, chorioamnionitis, premature rupture of the

membranes, skin and joint lesions, and meningoencephalitis (Watts & Brunhamni, 1999).

The reported association of gonorrhea with pre-maturity has been conflicting. Amstey

(1976, as cited in Gutman, 1999) reported the rates of poor outcomes in his study were

the same, regardless of treatment during pregnancy. Amstey's high rates ofpre-maturity

were not found by Charles et al (1970 as cited in Watts & Brunham, 1999). One serious

sequelae is an association between pregnancy and disseminated gonoccocal infection, a

condition that usually requires hospitalization to adequately treat.








Bacterial vaginosis has been identified in a significant number of studies as strongly

associated with pre-term low birth weight. The Vaginal Infections and Prematurity Study

Group reported an odds ratio of 1.4 for bacteria vaginosis and preterm delivery of a low

birth weight infant (Hiflier et al, 1995). The Patient Outcomes Research Team (1998)

reported that bacterial vaginosis in women of black race/ethnicity accounts for 40% of

excess pre-term births. They also demonstrated that antibiotic treatment for bacterial

vaginosis in pregnancy reduced pre-term deliveries. Eschenbach (1999) and Hilier and

Holmes (1999) provide comprehensive reviews of bacterial vaginosis. The authors note

the strong associations between this infection and adverse pregnancy outcomes, and the

positive impact (albeit conflicting impact) that treatment during pregnancy has in reducing

incidence of prematurity. Eschenbach also provides a discussion on the potential

association between fetal and maternal immune response in the presence of infection with

bacterial vaginosis.

The actual impact on low birth weight from bacterial vaginosis is probably

underestimated since this condition is roughly twice as common as other reportable STDs

and also asymptomatic. However, a recently completed national muti-centered study

failed to provide the needed evidence that treatment for bacterial vaginosis during

pregnancy reduces the likelihood ofprematurity or low birth weight (Hifflier, 1998). Two

other areas of concern with bacterial vaginosis (BV) are the non-sexual acquisition of the

syndrome and the role of BV in HIV acquisition. Black women are three times more likely

to have BV regardless of the number of sexual partners, and in the absence of sexual

partners. In contrast white women are more likely to develop or acquire the condition with

increasing number of partners (Hilier, 1998). Numerous studies suggest that BV enhance






63

the acquisition of HIV infection during and after pregnancy with adjusted odds ratios of

1.5 to 3.7 (Hillier, 1999).

Nair and others (1993) reported that HIV vertical transmission was increased with

the presence of clinical chorioaminionitis, any sexually transmitted infection during

pregnancy, and associated with LBW (p < .05). Those infants born before 35 weeks were

significantly smaller than infants non-infected with HIV.














CHAPTER 3
METHODOLOGY



In this chapter the research design, protection of human subjects, confidentiality,

data sources, development of the relational database, methodological issues in the use of

administrative databases, definition of study variables, data analysis, limitations, and

assumptions are addressed.


Research Design



This was a retrospective epidemiological study of a population-based sample of

pregnant women and adolescents who initiated prenatal care through county health

departments. A relational study database was constructed from linked data files. The files

were extracted from numerous administrative databases. The records of infants born

during 1996 and their mothers were linked to laboratory tests, disease reports, and

prenatal screening information through the use of probabilistic matching algorithms.

Descriptive analysis of al files and the extracted study file was conducted. Logistic

regression analysis was conducted to further explore the association between infection

with Chlanydia trachomatis and low birth weight. The data sources, process of matching

records, and analysis that was conducted are described in detail below.








Protection of Human Subjects


"Thiswas a retrospective epidemnriologic analysis of existing data. The University of

Florida, Health Center Institutional Review Board, and the Florida Department of Health,

Review Council for Human Subjects, both approved the study protocol The request to

waive documentation of informed consent was approved by both groups. No direct

contact was made with subjects. No treatment or care was provided or altered for the

subjects included in this study. Since this study retrospectively examined existing

information, no individual informed consents were deemed necessary by either review

body. The reporting ofbirths and fetal deaths and ofpositive tests diagnostic of the

sexually transmitted infections studied and morbidity information is required by law;

Chapters 382 and 384, Florida Statutes. The original consents to examine the data sets as

outlined in the study protocol were obtained from the respective administrative data

managers charged with the confidential maintenance of each data systems that contained

the morbidity or vital records. Oversight review for the study was provided by Department

of Health Review Council for Human Subjects.


Confidentiality

During the entire duration of the research period, the confidentiality of all data

systems was maintained in compliance with confidential security management protocols of

the Florida Department of Health. The study data set was stored on a server with access

limited to the investigator and four other departmental staff who assisted with the data

extraction process. The final study data set constructed through the matching process was

password protected and accessible only to the investigator. The researcher was assisted by








departmental staffto extract existing data from multiple data systems maintained for

tracking of client clinic services, recording of client laboratory services, and billing. The

matching of data files was conducted by departmental staff in the routine course of

activities conducted to examine quality of care, evaluate health programs, and manage

data systems. All data systems variables were matched with identifiers of the subject

intact. All hard copy information and computer files were stored for the duration of the

study according to protocol During analysis, the accumulated data were examined,

aggregated, and formatted into a structure useful for analysis without the use of client

identifiers.


Data Sources

Variables for the study data set were extracted from six administrative databases.

These databases were 1) 1996 birth records; 2) 1996 fetal death records; 3) Healthy Start

prenatal screen; 4) Maternal and infant laboratory test results; 5) Maternal and infant case

morbidity; and 6) Congenital syphilis records. Each are described below and information is

provided about the software, hardware, and flow of the data from point of collection to

final repose in the data system from which it was extracted for this study.

Birth and fetal death records. The birth and fetal death records were the first two

databases from which study data was extracted. The first statewide vital statistics law for

Florida was enacted in 1899, establishing a system for physicians to report births and

deaths (Porter, 1901). On January 1, 1917 the first comprehensive registration system

based on the national "Model Vital Statistics Act" became effective in Florida, after earlier

passage in 1915 by the State Legislature (Feamrside, 1916). The base study Sfie, the birth








record file, is an extraction from this vital statistics database. The fetal death records were

also extracted from the vital statistics database. Some of the information regarding birth

and death records is similar, and some aspects are dissimilar. The following discussion will

note where they are similar and where they are different.

The registration of births and fetal deaths is both a local and state function of 67

local registration districts corresponding to the jurisdictional area of the county health

department. (Office of Vital Statistics, 1996b). The county health department director or

administrator serves as local registrar for that county. It is his/her responsibility to oversee

the timely and complete registration of births and deaths occurring in their district. Once a

birth or death event is accepted for registration, the local registrar maintains a copy of the

vital record and forwards the original to the state office.

The information contained in the vital birth and death record is obtained from the

following sources: mother, father, relatives or persons who have knowledge of the facts,

physicians, midwives, fimeral directors, and hospital records. A standard form is used to

record and register the information required by the vital statistics law, Chapter 382,

Florida Statutes. The registration form in use during 1996 reflects the national model birth

record (Office of Vital Statistics, 1996b). The Florida birth registration form supports

collection of all recommended data from the model birth record, with the notable

exception of parental occupation. The hospital administrator (or if the birth is non-

institutional, the birth attendant) is required to file within five days after the birth a

complete and accurate birth certificate with the local registrar. The certificate must be

signed by at least one parent, attesting to the accuracy of the information, and either the

hospital administrator or designee, or birth attendant for non-institutional births. Chapter








64V-1 of the Florida Administrative Code provides clear direction on the preparation of

the certificate regarding paternity, maternity, birth attendance, the child's name and

surname, and residency. Local registrars provide regular training to hospital medical

records staff and the clerical staff responsible for completing the birth certificate (Office of

Vital Statistics, 1996b; R. Shepard, personal communications, June 30, 1999). The birth

record segments reflect the handbook directions and training provided to collect the

information from the numerous sources. The first segment has the legal demographic

information. This detail should be collected from the mother, father or other person with

"knowledge of the facts." The second segment contains the medical and health history

information. The medical history detail should be collected from the medical records, with

both delivery and prenatal supplied to the hospital (or birth attendant, or center). The

details about the condition of the neonate should be collected from the neonatal unit

records, e.g., abnormal conditions of the newborn, anesthetic complications, etc.

Clear directions and regularly conducted training sessions do not necessarily

translate into accurate completion of birth certificates (Sammet, personal communications,

June 30, 1999). During the data entry process at the state registrar's office, a staff member

telephones county health departments for clarification if they are unable to decipher data

on the birth certificate. Routine quality assurance reports are completed monthly to

identify outliers in data field. Habitual problems like late reporting, or high error rates in a

particular data fields are generally identified and addressed at the local registrar's level

though consultation with the hospital administrators. Persistent problems and unusual

outliers in the data are addressed by visits to the hospital from the local registrar or from








state registrar's quality assurance office staff (R Shepard, personal commmications, June

30,1999).

Florida Statute section 382.002(7) requires that fetal death certificates record "the

death of a product of conception prior to the complete expulsion or extraction from its

mother, if the twentieth week of gestation has been reached." The statute further provides

that every fetal death must be registered within five days after the delivery occurred, and

prior burial, disposition, or removal from the state (Office of Vital Statistics, 1996b). The

funimeral director, direct-disposer, or physician/midwife who attended the delivery and is

responsible for registering the record, completes the registration record. The certificate of

fetal death is to be signed by the physician in attendance. The midwife may sign as actually

having attended the delivery but not as to the cause of death. The hospital administrator is

responsible for providing the medical details to the funeral director in charge of the

burial/disposition arrangements. The data entry and quality assurance for the fetal death

registration is the same as for the birth certificate.

The data entry for both files is conducted on personal computers. The two files are

supported by proprietary software and maintained and stored on a mainframe computer

system housed in the Department of Children and Families. Hard copies of the data are

regularly microfilmed. The two files, the birth record and the fetal death record were

extracted in separate programs from their respective databases. Staff in the Department of

Heath then combined these two files after realignment of the fields to create one

continuous birth fetal death record file. In the routine course of operations at the Office of

Vital Statistics these records are maintained separately at all times. Quality assurance

measures are regularly employed to assure that infants initially reported as a birth are not








later reported also as a fetal death. Monitoring steps are designed to identify inappropriate

registration combinations of certificates for the individual live born infant or stillborn

infant. This combined data set provided key variables for the final study database, and are

presented in Appendix A. It also served as the base file against which all other files were

matched and linked to in the final relational study database.

Healthy Start prenatal screen database. The Healthy Start prenatal screen is the

third database from which study files were extracted. In 1991, the Florida Legislature

enacted the Healthy Start program with the creation of Chapter 383.2161 ofthe Florida

Statutes and development of Chapter 64C-7, Florida Administrative Code. Implemented in

April 1992, this program was modeled on prenatal case management programs in other

states like South Carolina and international studies that demonstrated the value of non-

medical interventions for women and infants at risk of low birth weight, infant death, and

developmental delay (Thompson, 1993; Florida Department of Health, 1997b). The core

components of Healthy Start include: 1) universal screening of all pregnant women and

newborns, 2) professional assessment of health, social and environmental risks, and 3)

targeted case management and risk appropriate care. Expanded Medicaid eligibility to

185% of the federal poverty level, and provider reimbursement to providers to administer

the prenatal screens further support the Healthy Start program goals of improved

pregnancy outcomes (Florida Department of Health and Rehabilitative Services, 1995).

First trimester screens are reimbursed at a higher rate in support of timely intervention

(Florida Department of Health, 1998).

The Healthy Start prenatal screen data set was extracted from an existing system

database housed in the Florida Department of Health, Office of Vital Statistics,








Jacksonville, Florida. The source document for this data set is the Healthy Start prenatal

screen. All prenatal care providers are required by law to administer the screening

instrument to pregnant women, preferably at their initial prenatal visit. The screening

instrument collects demographic information and responses to a series of "risk" questions.

The questions are based on medical, psychosocial, and environmental factors associated

with increased risk of poor pregnancy outcomes. A score is calculated based on the risk

factor, and the strength of the risk as a predictor of poor outcomes (Serow, Jones, &

Luke, 1996). In addition to the demographic, medical and provider information collected,

the psychosocial and environmental variables capture risk information about educational

level, access to care, housing, and food, drug, alcohol and tobacco use, risk of domestic

violence, and perceived level of personal stress.

The particular "risk" factors included were initially based on extensive review of

the literature and an evaluation of birth and fetal death records for associations commonly

observed in the Florida population among low birth weight infants and infant deaths. Two

different years of birth records were evaluated in development of the prenatal screening

instrument utilized since 1994. The 1989 birth and fetal death records were used to

calculate risk ratios on commonly held risk associations, e.g., age less than 18 years, age

over 39 years, unmarried, etc. If a factor occurred in more than 1,000 births and had an

associated risk ratio of greater than twice the average risk, then it was considered a

potential "risk factor" and included in the initial screening instrument (Thompson,

Hopkins, & Watkins, 1993).

After the first two years of use, a second evaluation utilized the prenatal screens

and the birth records for the period between April 1, 1992 and April 30, 1993 (Thompson,








Hopkins, & Watdkins, 1993). The adverse pregnancy outcomes were birthweight under

2,000 grams and/or birth date of less than 34 weeks from the date of last menses. The

same adverse outcomes were used to develop the initial screening instrument after

examination of neonatal and postnatal death rates from 1991. It was noted that Florida

death rates were high at birth weights below 2,000, and dropped off above this cut-off

point as compared to the more universally used 2,500 grams. Likewise the death rates

level off above 34 weeks between last menses and birth date. The positive predictive value

of each screening tool risk factor was analyzed from the linked birth records and prenatal

screens. Additionally, besides effectiveness of the screening tool to identify women at risk

of an adverse outcome as defined in the analysis, the related workload to the county health

department was considered. At the recommendation of the Healthy Start Advisory

Committee, a few subtle changes were subsequently made to the scoring weights and risk

factors in the revised 1994 form to achieve a predicted positive screening rate of 39.98%

and sensitivity of 60.64%.

One copy of the screening instrument is forwarded to the Office of Vital Statistics

for data entry. During 1995 and 1996, the data entry system was constructed to require

that all fields were "must enter fields." This data entry system was envisioned as

appropriate to aid evaluation of the instrument and the program in the early phase of

legislative implementation. Any record that was found to have an incomplete data field

was placed in a query status and returned to the local county health department. It was

then the responsibility of the local authorities to contact the appropriate public or private

prenatal care provider and ensure completion of the missing data (K. Freeman, personal

communication, June 30, 1999). During 1997 after the preliminary evaluation, some fields








were changed to reduce the restriction on the data entry process. This change resulted in

higher rates of query flags on many variables.

The primary use of the information collected on the prenatal screening instrument

is to calculate a risk score and provide the clinician with a platform to seek consent from

the woman to assess her need for targeted services. As with other screening instruments,

the intent is a rapid reliable assessment of an at-risk status. The data entry process was not

envisioned or fimded to support a standard consistent with research protocols. During the

data entry process verification of the data fields is restricted to four fields: name, social

security number, score, and date of the screening event (J. Ballard, personal

communication, June 30, 1999). However the Healthy Start coalitions are charged with

the responsibility to designate an agency that will provide training to providers on correct

use of the form, model successful solicitation of the screening process, and identify

patterns of positive risk within the community in order to target resources. Additionally,

the county health departments are charged with the responsibility to monitor the screening

instruments for completeness and coordinate the collection of missing data on queried

forms returned from the Office of Vital Statistics. This data set provided key variables for

the final study database, as are presented in Appendix A.

Maternal and infant laboratory test report database. The maternal and infant

laboratory test report database is the fourth source from which study files were extracted.

The laboratory Gen-Probe PACE2C test report data set was extracted from an existing

system database housed in the Department of Health, Bureau of Laboratories,

Jacksonville, Florida. This system was developed to support reporting compliance with

state and federal laws and regulations regarding biological specimens submitted for








testing, and timely billing of providers. Following is a review of the system specifications

and the flow of data into that system, as regards specimens submitted for testing with the

Gen-Probe PACE2C* nucleic acid hybridization technology (S. Crowe, personal

communication, June 29, 1999).

Beginning in December 1995, the Florida Department of Health, Bureau of

Laboratories commenced implementation of a long-range plan to computerize and store all

test-related data in an electronic system. This represented a transfer from a hardcopy filing

system based on specimen ascension numbers to an electronic data system, allowing recall

of a particular test results) from numerous demographic or biological variables, and the

ascension number. Additionally, the database was structured to support centralized biing

to providers, regardless of the branch laboratory at which the specimen was processed.

Each laboratory was brought onto the new system sequentially, beginning with the main

branch site that processed the highest volume of specimens. By late-year 1996, all branch

laboratory computer systems were functional, as was the central statewide database.

During this same period many test reports from the branch laboratories actually were key

punched into the system at the central office site, to facilitate the billing process.

The system software written in Massachusetts Utility Multi Programming System

(MUMPS) language is a proprietary product. During 1996, it is run on a Unix platform

operating system through centralized servers linking the five branch laboratories. Data are

entered from personal computers located in each respective area of the laboratory. In the

routine course of laboratory operations specimens are received in the delivery/mailroom.

At this initial point specimen labeling is matched against test requisition slip data for

accuracy, completeness in accordance with state and federal laws, and regulations









regarding biological specimens. A numbering machine is then used to stamp the requisition

slips sequentially with coded numbers reflective of the branch laboratory, area of the

laboratory in which the test will be conducted, and by specimen ascension. For example

"JSGxxxxxxxx" is Jacksonville Serology Gen-Probe followed by the accession number.

Preprinted labels are simultaneously numbered with the sam accession number by a

different machine. These preprinted labels are attached to the specimen vial or container

for tracking within the computerized system and through laboratory processing.

Specimens then are transported to the respective area of the laboratory to begin testing.

On arrival into the respective laboratory areas, laboratory technicians enter the ascension

numbers to create the test record in the computer system, along with the date the

specimen was received and the name of the test requisitioned. Additionally, the specimens

are noted for compliance with acceptable collection to testing time frames according to the

individual test type requested. During the period that specimen testing is in progress data

entry operators begin to enter the demographic information into the computer record

created for each specimen. Variables entered at this stage included: last name, first name,

social security number, address, insurance numbers, date of birth, race/ethnicity, sex, date

of specimen collection, provider code, program code, county where specimen originated,

provider address and name, the patient diagnosis, the physiologic source of the specimen

and the laboratory site identifiers.

On completion of the testing process the laboratory technicians check 100% of the

demographics on the specimen labels against the data that has been entered into the

computer tracking system prior to reporting out the test results on each specimen. This

process is aided by a demographic quality assurance report printed out from the system








prior to entry of the test results. During the course of testing the test results are verified

and any applicable qualifiers or specimen rejections are entered into the system, along with

the names of those reporting the results. Data error can and does occur at the initial phase

of specimen and demographic registration into laboratory computer systems. Dauly quality

assurance activities monitor data entry of demographic information and the reporting of

test result&

During 1998, an unfortunate series of events occurred that caused corruption of

segments of the database affecting calendar years 1996 and 1997. While much ofthe

primary database was subsequently repaired from archival tapes, not all of 1996 or 1997

test reports could be restored. Hard copy requisition slips are maintained in archival files

for the seven-year time period as required for medical records by law, Chapter

483.051(7Xf), Florida Statutes. The extent and the scope of the damage to the electronic

operating system and hardware was not identified until many months after this study was

conceptualized, the protocols written and approved, and countless hours expended on

matching of records to the base study file had commenced. Hence it was impractical at

that point to consider re-framing the study around a different birth cohort. Unfortunately,

these records are stored according to specimen ascension number. The estimated cost for

retrieval of missing test results for subsequent re-entry into the data system would serve

no laboratory purpose and was cost prohibitive to this investigator in terms of the study

budget. There is no reason to believe that the individual test reports contained in the Gen-

Probe test report data set are any more or less complete in any given time segment for the

period included in this study. There is reason, however, to believe that the distribution of

the test reports is constrained by both the events associated with the implementation ofthe








computer system and the described corruption event that occurred. The skewed

distribution is discussed below in the results chapter. However, one of the strengths of this

data set is the representiveness of specimens collected from women receiving prenatal care

in county health departments.

In the initial step, an extraction using MUMPS was made from the primary

laboratory data system to select data fields with information pertaining to Gen-Probe

PACE2C (S. Shiver, personal communication, June 30, 1999). This extraction was done

through the use of programming with Visual Basic to create a database flat file. The files

were then transferred onto the Sequel Server subdirectory. (The NT platform operating

system replaced the Unix system in late 1998 following the discovery of the system

failure.) The files were then accessible through the closed-frame relay departmental wide-

area network to the Bureau of STD staff with appropriate authorization and passwords.

At the next step FOX PRO programming software was used to construct an ASCI flat file

extracting only the desired study variables. In this step some variable fields were made to

conform to numeric codes consistent with the base study file, the 1996 Birth Fetal Death

Records, (race, ethnicity, county), and the Year 2000 date format (YYYYMMDD).

Extraction parameters included: all Gen-Probe PACE2C reports with collection date

between March 1995 through June 1997, for females regardless of date of birth, and

reports for males with a date of birth during 1996. The following variables were extracted

to support the matching process and for subsequent descriptive analysis: last name, first

name, social security number, date of birth, race, sex, address, county, specimen number,

date of specimen collection, test type, and results for both Chamydia trachmatis and

Neisseria gonorrheae. The extraction totaled 214,121 records from the primary laboratory








Gen-Probe PACE2C database that met the time, test, and gender study parameters& Each

woman and infant had two records, one for chlamydia results and a second for gonorrhea

results. This data set provided key variables for the final study database, as are presented

in Appendix A

Maternal and infant case morbidity database. The maternal and infant case

morbidity database is the fifth source from which study files were extracted. Sporadic

reporting of "venereal diseases" by providers to the authorities dates to 1918. By 1920 the

numbers of venereal diseases reported exceeded the total of the next three causes of illness

(Hardy & Pychon, 1964). In 1921 the Bureau of Venereal Diseases faded into the Bureau

of Communicable Diseases and it was not until 1938 that finds were appropriated to

support reporting again. Prior to World War II (in 1944) Florida saw the establishment of

a central registry for syphilis (Brink, 1944). That same year the Legislature enacted

prenatal and premarital serology for syphilis. The present centralized computer dates to

1988 and contains records of 458,771 case reports for syphilis, chlamydia, gonorrhea,

chancroid, lymphogranuloma venereum, and since 1997, human immunodeficiency virus

(K. Kampert, personal communications, June 30,1999). The maternal and infant case

morbidity data set was extracted from this existing STD Case Morbidity Reporting

database housed in the Florida Department of Health, Bureau of STD Prevention and

Control, Tallahassee, Florida.

The details of a STD case report travel through numerous hands before actually

entering the system, defined as a "case." At the onset a suitable specimen suspicious of a

STD must be collected and forwarded to a laboratory for testing. Laws and regulations

require that laboratories and physicians both must report all positive tests diagnosing a








reportable sexually transmitted disease per Chapter 384.25, Florida Statutes and Chapter

64D-3, Florida Administrative Code. These reports are made available to the county

health department. During 1995 and 1996 the information from positive laboratory reports

and physician diagnoses was entered into the morbidity system and then field records were

produced to support the activities of disease investigator staff to verify the case details

with the physician or other provider. During this same time period, verification of

treatment was implemented for gonorrhea and chlamydia. Due to the enormous volume of

chlamydia and gonorrhea cases and staffing constraints, this was not previously a

requirement. During this time some counties also began to verify the case data, patient

treatment, and partners) treatment for pregnant women, if the case report indicated the

pregnancy status. All opthalmia neonatorum and neonatal pnuemonia cases were

individually verified for the demographic, treatment, diagnosis and provider data during

this period of time.

Routine quality assurance reports were run at the local district reporting level

These were used to verify that all positive cases had an age, sex, and race identified (P.

Moncreif personal communication, June 30, 1999). These morbidity reports were in turn

then reported to the Bureau of STD Prevention and Control (known as the Office of

AIDS/STD/TB at that time). At the state level, scheduled quality assurance reports are run

to identify outliers, any duplicate records, and contradictory diagnosis code& An example

of an outlier that would be a red flag: a greater number of positive laboratory test reports

from an area that has reported a disparately smaller number of cases. It would be more

usual to see the reverse pattern identified. Annually, morbidity line lists were produced and

then forwarded to the district STD offices for verification of case numbers, age, race,








name, and diagnosis. Generally, the age and sex fields have a 98% completion rate, with

race ranging from 80-85%. This difference is the result of absent race/ethnicity

information from private providers. Each of the quality assurance components is

applicable to the discrete study data set time period. This data set provided key variables

for the final study database, and these are presented in Appendix A.

Congenital syphilis database. The congenital syphilis records are the sixth and final

database from which study files were extracted. This database is managed much as the

maternal and infant morbidity database above. However it was separate proprietary system

created circa 1990 and not linked electronically to the maternal or infant case morbidity in

the Sexually Transmitted Disease Management Information System (STD*MIS). The

movement of information into this system differs from that of the morbidity system in one

distinct way. All data entry for the 1996-birth cohort of congenital syphilis cases was done

in the Bureau of STD, unlike the maternal and infant case morbidity that was entered at

the local STD area offices. Additionally the data on each case was initially submitted on

lengthy case worksheets. Bureau of STD personnel then confirmed the details of the

mother's syphilis laboratory test results, her diagnosis, and treatment history. With this

additional information the case determination was made as to whether or not the

submitted congenital syphilis case report was indeed either a true clinical and laboratory

confirmed congenital syphilis case, or a case that met the national surveillance definition

for '"probable" congenital syphilis (CDC, 1998a). The case determination for congenital

syphilis applied to both live infants born to untreated or inadequately treated infected

women and to syphilitic stillbirths. A positive feature of this database was the close

scrutiny that each case received during the determination process. A limitation of this








database with its stand-alone design was the failure to directly link by computer the infant

case congenital records to the maternal case history, laboratory tests, or treatment records.

This weakness has been resolved in the 1998 STD*MIS system version with the

development of an internal congenital syphilis module.


Methodological issues in the use of administrative databases

Teutsch and Churchill (1994) make recommendations regarding the management

of databases to maintain the integrity and completeness. Among the issues that must be

addressed are the credentials of data entry staff updating of records, back-up of computer

files, automatic data entry fields, e.g., today's date or today's age calculated from date of

birth. Controlled system parameters and "must enter" fields are useful to ensure accurate

spelling of common variables, e.g., county names, and validate data entry for

completeness. No documented independent validation studies have been conducted on the

data contained in any of these data systems and entered during the period spanning late

1995 to the middle of 1997, the timeframes for data-sets included in the study. However,

routine production of quality assurance reports facilitate the identification and frequency

of common errors, identify the appropriateness of the range of values entered, and assess

the completeness of demographic data entry from each of the systems from which these

data set were extracted.

Other published guidelines provide suggestions for the evaluation of surveillance

systems like the STD maternal and infant case morbidity and congenital systems used in

this study. Evaluation of a surveillance systems should include 1) description of the

importance of the health event under surveillance, 2) description of the system, 3)








characterization of the usefulness of the data for decision making processes in public

health, 4) evaluation of the actual system for attributes such as simplicity, sensitivity, and

representativeness, 5) direct costs, and 6) recommendations (Klaucke et. aL, 1998; WHO,

1997). No documented independent evaluation reflective of these guidelines has been

conducted on the data contained in any of these surveillance systems.

Reliability of the information in each data sets utilized from which to extract study

variables is an issue common to all of the systems. Herrmmm (1985) compared self-

administered to interviewer-administered questionnaires in a case controlled study for

agreement and reported that consistently higher agreement levels for medical history with

interviewer-administered questionnaires was observed. Harlow and Linet (1989)

conducted a literature review of studies comparing data from questionnaires with

information derived from medical records. Significantly high accuracy over extended

periods of time was noted for each woman's recall of her pregnancy histories, childbirth

experiences, and events. Less reliability was observed for menarche, menstruation, and

menopause timeframes. All but one of the study data sets utilized interviewer-administered

questionnaires and medical extraction followed by data entry into the data systems from

hard copy records The one exception, Healthy Start prenatal screen, is often completed

by the pregnant woman, but may also frequently be interviewer-administered.








Definition of Study and Indicator Variables

The study variables used by this investigator were obtained from different data sets

within the linked relational database. Dependent variables and independent indicator

variables were created to support the calculation of crude odds ratios and the logistic

regression analyses. Please see Table 3.

The list includes the following: alcohol use in pregnancy, alcohol use in the last

two months, birth interval, body mass index group, chlamydia positive, gonorrhea

positive, gestational age, high school graduate, history of past or current sexually

transmitted disease, inadequate weight gain, low birth weight group by gestation, low

birth weight, marital status, medical history, mistimed pregnancy, mother was low birth

weight at birth, mother is of foreign birth, mother of black race, mother resides in a rural

area, prenatal care indices, prior poor pregnancy outcome, smoked during pregnancy,

smoked in the last two months, and stress identified in mother's life. All indicator variables

used in logistic regression were coded with '0' for absence of and '1' for the presence of

the designated condition, risk or measure. Other variables were coded according to their

use in the study analysis. Supportive syntax utilized for the indicator variables is contained

in Appendix B. The dependent variables included low birth weight and low birth weight

groups by gestational age. All other variables were used as independent variables in the

calculation of crude odds ratios and for the logistic regression models. Due to the

complexity of some variables, and their development from multiple database variables,

more in-depth explanation follows.









Dependent variables: (Please refer to Table 3.).

Low birth weight (LBW) was defined as birth weight greater than or equal to 500

grams and less than or equal to 2499 grams. All live births and fetal death records without

a recorded weight, a weight of less than 500 grams, or more than 5,500 grams (302

births/0.6%) were assigned to the "missing values" in the computations.

Table 3. list of All Variables Used in Analysis.


Dependent Variables

1. Low birth weight
2. Term low birth weight
3. Pre-term low birth weight

Independent Indicator Variables

1. Age< 18, > 40
2. Alcohol use from birth record
3. Alcohol use from Healthy Start screen
4. Birth interval short
5. Chlamydia positive
6. High school -no-
7. Gonorrhea positive
8. Inadequate PNC indices
9. Inadequate weight gain
10. Married not
11. Medical history
12. Mistimed pregnancy
13. Mom foreign born
14. Mom LBW
15. Prior poor pregnancy outcome
16. Race of mother black
17. Rural residence
18. Smoking from birth record
19. Smoking from Healthy Start
20. STDs, past or current
21. Stressful life









Term low birth weight (TLBW) was birth weight defined as greater than or equal

to 1500 grams and less than or equal to 2499 grams and gestational age equal to or

greater than 37 weeks. Pre-term low birth weight (PTLBW) was defined as LBW with

gestational age of equal or greater than 20 weeks and equal or less than 36 (Ventura,

Martin, Mathews, & Clarke, 1996; Graf& Perez-Woods, 1992). LBW, PTLBW and

TLBW were the dependent variables for the logistic regression models

Gestational age was calculated from the date of birth and date of the last menstrual

period reported on the birth certificate (Ventura, Martin, Curtin, & Mathews, 1999).

Where the day of the month was missing the fifteenth was imputed (Buescher, Smith,

Holliday, & Levine, 1987). Reported gestational age in weeks had a slightly narrower

standard deviation (2.56) compared to that of estimated gestation (2.84). In addition, the

skewness for the reported gestation was larger (1.07) compared to the skewness for the

calculated gestation (0.42). When those births with computed gestational age less than 20

weeks and greater than 42 weeks (11.4%) were removed, the skewness was reduced even

further to (0.37), with a histogram that presents a more normal curve. Given this

information, the assumption was made that the calculated gestational age is more reliable

since the calculated gestational age exhibited a more standard bell-shaped curve than

reported gestational age. There may be bias in the reported gestational age data due to the

fact that reported gestation is recorded after the birth has occurred and the size, weight,

and appearance of the infant may influence the clinical estimate of gestational age. Some

researchers have expressed concern that calculated gestation from the LMP date

underestimates in the direction ofpre-term deliveries (Kramer, McLean, Boyd, & Usher,

1988). There may also be recall bias associated with the calculated gestational age. The








last menstrual period date could be entered onto the birth or fetal death record based on

either information contained in the prenatal records collected long before the birth and

available at the time of the delivery, or on maternal recall However calculated gestation is

not as likely to be influenced by the birth outcome.

All live births and fetal death records without a recorded last menstrual period

(LMP) or a LMP month with a value of more than 12 or less than 1, from which to

compute the gestationwere assigned to the missingg values" category (12,557/6.4%).

Additionally, following calculation, any record with a gestational age less than 20 weeks

(79/0.2%) or more than 42 weeks (6,373/3.3%) was also assigned to the "missing values"

in the computations.

Two other methods have been employed elsewhere but not in this study to address

inconsistency in birth weight to gestation ratios. One method is a comparison of the

calculated to the estimated with selection of the one most consistent with the reported

birth weight. Another method has been to redistribute all records with inconsistent outlier

values to the distribution observed in those with valid parameters.

Independent indicator variables: (Please refer to Table 3.).

Age at the time of delivery was calculated from maternal date of birth and

incrementally grouped into < 15, 15-19, 20-24, 25-34, 35-39, 40-44, and > 45 years for

the initial analysis and calculation of crude odds ratios. For the logistic regression

modeling, the maternal age variable was assigned a value of' '1' for women younger than

18 and women 40 years or older, and a value of'0' for age 19 to 39 (Gjerdingen, 1992;

Buescher, Taylor, Davis., & Bowling, 1993; Ketterlinus, Henderson, & Lamb, 1990;

Rosenfeld, 1990).









Alcohol use in pregnancy was obtained from a field on the live birth certificate.

When 'yes' is answered, a secondary part asks for the average number of drinks per week.

This variable does not allow for identification of when, during the pregnancy, alcohol was

consumed, or if the woman drank and then stopped drinking once she realized she was

pregnant.

Alcohol use in the last two months was obtained from a field on the Healthy Start

prenatal screen. This variable does not allow for clarification if the consumption took

place prior to the onset of pregnancy, as might be the situation where a screen was

conducted early in the first trimester. When considered alone, the information from this

variable does not provide clear information on the quantity of alcohol consumed, or

whether the woman drank throughout the pregnancy. Both of these variables are a crude

measure of alcohol use in pregnancy and do not provide an accurate level of risk

assessment or measurement.

Birth interval was created to capture information on the time from any prior event

of pregnancy regardless of outcome, and the present birth. Many authorities have long

espoused that a woman should ideally space births two years apart to allow their bodies to

replace reserves and recover physiologically from the pregnancy and birth processes

(Youngkin & Davis, 1994). Researchers in Utah recently defined a short inter pregnancy

interval (IPI) as one that was less than 12 months based on a parallel study that

demonstrated an increased association for adverse perinatal outcomes with IPIs of less

than 12 months (Duncan, Nagle, Streeter, Bloemaum, & Tingey, 1998). This group

calculated the IPI from the time between delivery dates of consecutive live-born infants

and the gestational age of the most recent child. Another study conducted in Florida








examined the association between low birth weight and the interval between pregnancies,

reporting that the LBW increases markedly at IPI of less than 9 months (Thompson,

1995). In the second study, the inter pregnancy interval was calculated from the date of

the last menses and the date of the last live birth, both of which were taken from the birth

record. This calculation was utilized for the indicator variable with a value of '1' given to

those women with the designated risk of a birth interval less than 9 months.

Body mass index group was calculated in numerous steps based on the following

formula: weight [kilogramsj/height [meters]2 (Abrams & Parker, 1990; Anderson,

Anderson, & Glanze, 1994). Initially, the weight in pounds before pregnancy from the

Healthy Start prenatal screen file was converted to kilograms. The height in feet and

inches was then converted to height in meters. In the next step the weight in kilograms

was divided by the height in meters squared to assign a body mass index value to each

woman. The calculated score placed a woman in an underweight, normal weight,

overweight, or obese category according to published standards for pregnancy BMI

(Florida Department of Health, 1999).

Chlamydia positive and Gonorrhea positive were both taken from the Gen-Probe

PACE2C test results contained in the laboratory data file. Only those test results

designated either positive or negative, were used in the analysis. All results designated

indeterminate or unsatisfactory were assigned to 'missing' for clarity of interpretation.

High school graduate was calculated from information on the mother's highest

level of education completed contained on the birth record, grouped as having not

completed high school, having competed 12 years of education and as having completed

more than 12 years. For the logistic regression analysis, women with an age of equal to or








greater than 18 years at the time of delivery and having less than or equal to eleven years

of education completed were value of '1' for the designated risk of not having completed

high school While an age appropriate score was not assigned to younger adolescents, this

variable does not 'penalize' a young teen for not yet having completed high school at the

time of delivery, or place a younger adolescent within the risk category.

History of past or current STD was created to capture fragmented information

contained in the multiple data sets. Due to distinctly differing rationales to record or not

record any information related to a history of a recent past or present STD, all possible

positive events were captured. However, a woman was only counted once if any field was

positive for any STD event. A report of herpes in this pregnancy from the birth record was

not included. 'Yes' responses were included from the following fields:

1) chlamydia positive or gonorrhea positive on either the mother's laboratory

linked file or the infant's file;

2) a morbidity case report for the mother designating a condition of chlamydia,

gonorrhea, pelvic inflammatory disease, primary, secondary or early syphilis;

3) a morbidity case report for the infant designating a condition ofchlamydial

opthalmia, gonorrhea opthalmia, chlamydial pneumonia, or congenital syphilis;

Inadequate weight gain was computed from the body mass index (BMI) group,

gestational age in weeks and recommended weight gain ranges in pregnancy for each BMI

group. Any woman not achieving the recommended weight gain was assigned a designator

risk measure of'l'. (Florida Department of Health, 1999). See Appendix X for more

detail on the applicable calculations.

Marital status was defined as married or unmarried.




Full Text
173
The implications for intervention in the spread of chlamydia, syphilis, and
gonorrhea infections go beyond the clinical setting. Additional training on the elicitation of
complete sexual behavior, menstrual and obstetric histories should be provided to nurses,
advanced practice nurses, and other health professionals such as STD disease
investigators, who work in settings where contact with reproductive age women is likely.
Provision of such training might serve to raise the index of suspicion of infections
associated with pregnancy, and thus assist public health department clinicians and health
professionals to better identify associations between STDs and adverse pregnancy
outcomes such as fetal deaths, spontaneous abortions, and altered menstrual patterns that
are suggestive of chlamydial infections.
The findings related to inadequate weight gain suggest several implications for
change in the way that prenatal nutritional services are delivered. At present, women are
provided nutritional counseling and risk assessment when they are enrolled into the WIC
program Generally, there is no further evaluation of a womans individual progression
toward the desired weight gain in pregnancy by a nutritionist. Nurse practitioners and
certified nurse midwives should continue to intervene with nutrition counseling. In light of
the persistent association identified between inadequate weight gain and low birth weight,
term low birth weight and pre-term low birth weight, implementation of interim nutritional
monitoring sessions would provide an opportunity to pose appropriate interventions
earlier than in the post-partum period following the adverse pregnancy outcome.
Therefore, advance practice muses should refer pregnant women with slow or undesirable
weight gain to the nutritionist, for collaboration on the development of a nutritional plan


27
estmate is from the Office of Technology Assessment, an 1988 estimate adjusted for 1998
dollars by Department of Health, Office of Health Planning and Evaluation.) Recent
analysis on Florida birth records for 1985 to 1990 suggest a significant association
between low birth weight of 1,500 and 2,499 grams and physical impairment (OR 4.35),
profoundly mentally handicapped (OR 4.75), educable mentally handicapped (OR 2.62),
and academic problems (OR 1.26) (Resnick et aL, 1999). Low birth weight infants are at
increased risk of neonatal and infant morbidity and mortality; nearly 70% of all infant
mortality, nearly one third of all handicapping conditions (Patient Outcomes Research
Team, 1998).
Biology of Chlamydia trachomatis
Chlamydia trachomatis is an intriguing pathogenic bacteria with a long history of
human contact and a distinctly unique growth cycle. Pathology- associated with the
bacteria was first described in Egyptian papyri (Schachter, 1999a). Most likely it predates
humankind as a species by billions of years. Halberstaedter and Prowazek first stained
conjunctival scrapings from orangutans infected with human trachomatous matter and
demonstrated the presence of inclusions in 1907. In 1914 Lindner isolated inclusions from
the conjunctival of infants, the genital tracts of their mothers, and the urethras of their
fathers (Schachter, 1999a). Tang and associates contributed the first isolation of
Chlamydia trachomatis from persons infected with LGV during the 1950s (as cited in
Schachter, 1999a). In 1959 Jones, Collier and Smith recovered the bacteria from the
cervix of a woman whose infant had opthahma neonatorum (as cited in Schachter, 1999a).
Other historical milestones are summarized in Table 2 below.


185
Buescher, P. A., Taylor, K. P., Davis, M. H., & Bowling, J. M. (1993). The quality of the
new birth certificate data: A validation study in North Carolina. American Journal
of Public Health. 83(81. 1163-1165.
Burstein, G. R., Gaydos, C. A., Diener-West, M., Howell, M. R., Zenilman, J. M., &
Quinn, T. C. (1998). Incident chlamydia trachomatis infections among inner-city
adolescent females. Journal of the American Medical Association. 280(61. 521-
526.
Bush, M. R., & Rosa, C. (1994). Azithromycin and erythromycin in the treatment of
cervical chlamydial infection during pregnancy. Obstetrics and Gynecology, 84(11.
61-63.
Byrne, G. I. (1996). Persistent chlamydial infections: An in vivo reality or a cell culture
artifact? Infectious Diseases in Obstetrics and Gynecology. 4. 149-151.
Cabral, FL, Fried, L. E., Levenson, S., Amaro, H., & Zucherman, B. (1990). Foreign-bom
and US-born Black women: Differences in health behaviors and birth outcomes.
American Journal of Public Health. 80(11. 70-73.
Calle, E. E., Thun, m. J., Petrelli, J. M., Rodriguez, C., & Heath, C. W. (1999). Body-
mass index and mortality in a prospective cohort of U.S. adults. New England
Journal of Medicine. 3411151. 1097-1105.
Carmichael, S. L., & Abrams, B. (1997). A critical review of the relationship between
gestational weight gain and preterm delivery. Obstetrics and Gynecology, 8(5).
865-873.
Cates, W., & Brunham, R. C. (1999). Sexually transmitted diseases and infertility. In K.K.
Holmes, P. F. Sparling, P. A. Mardh, S. M. Lemon, W. E. Stamm, P. Piot & J. M.
Wasserheit, (Eds.), Sexually transmitted diseases (3rd ed., pp. 1079-1087). New
York, NY: McGraw-Hill, Inc.
Cates, W., Rolfs, R., & Aral, S. (1990). Sexually transmitted diseases, pelvic inflammatory
diseases, and infertility: An epidemiologic update. Epidemiologic Reviews. 12.
199-241.
Cates, W., & Wasserheit, J. N. (1991). Gential chlamydial infections: Epidemiology and
reproductive sequelae. American Journal of Obstetrics and Gynecology, 164(61.
part 2, 1771-1781.
CDC. (1993). Use of race and ethnicity in public health surveillance. Morbidity and
Mortality Weekly Review. 42(RR-10).


209
chlamydia trachomatis in pregnancy. Infectious Diseases in Obstetrics and
Gynecology. 2. 205-209.
U.S. Department of Health and Human Services. (1989). Improving the quality of clinician
pap smear technique and management, client pap smear education, and the
evaluation of pap smear laboratory testing: A resource guide for title X family
planning projects. Washington, DC: Office of Population Affairs.
Ventura, S. J., Martin, J. A., Mathews, T. J., & Clarke, S. C. (1998). Report of final
natality statistics, 1994. Monthly Vital Statistics Report. 44111). Supplement.
Ventura, S. J., Martin, J. A., Curtin, S. C., & Mathews, T. J. (1998). Report of final
natality statistics, 1996. Monthly Vital Statistics Report. 461 111. Supplement.
Ventura, S. J., Martin, J. A., Curtin, S. C., & Mathews, T. J. (1999). Births: Final data for
1997. Monthly Vital Statistics Report. 47(18). Supplement.
Virji, S. K, & Cottington, E. (1991). Risk factors associated with preterm deliverieis
among racial groups in a national sample of married mothers. American Journal of
Perinatology. 815). 347-353.
Watts, A. FL, & Branham, R. C. (1999). Sexually transmitted diseases including hiv
infection in pregnancy. In K.K. Holmes, P. F. Sparling, P. A. Mardh, S. M.
Lemon, W. E. Stamm, P. Piot, & J. M. Wasserheit (Eds.), Sexually transmitted
diseases (3rd ed., pp. 109-1133). New York, NY: McGraw-Hill, Inc
Wentworth, B. B., Judson, F. N., & Gilchrist, M. J. R. (Eds.) (1991). Laboratory methods
for the diagnosis of sexually transmitted diseases (2nd ed., pp. 96-125).
Washington, DC: American Public Health Association.
Westrom, L. (1975). Effect of acute pelvic inflammatory disease on fertility. American
Journal of Obstetrics and Gynecology. 121. 707-713.
Westrom, L. V. (1994). Sexually transmitted diseases and infertility. Sexually Transmitted
Diseases. 2H2S1. S32-S37.
WHO. (1997). Protocol for the evaluation of epidemiological surveillance systems
Geneva: Division of Emerging and Other Communicable Diseases Surveillance and
Control
WHO Task Force on the Prevention and Management of Infertility. (1995). Tubal
infertility: Serologic relationship to past chlamydial and gonococcal infection.
Sexually Transmitted Diseases. 22(2). 71-77.


225
To create a medical history indicator variable.
(this combined chronic health problem, anemia, hypertension, eclampsia, etc from birth
record and Healthy Start)
compute medhind=0.
if (MHF1 ge T and MHF1 le '4') medhind=l.
if (MHF1 ge 6' and MHF1 le '12') medhind=l.
if (MHF1 ge T4' and MHF1 le T7) medhind=l.
if (MHF2 ge T and MHF2 le 4') medhind=l.
if (MHF2 ge '6' and MHF2 le T2') medhmd=l.
if (MHF2 ge T4' and MHF2 le T 7) medhind=l.
if (MHF3 ge T and MHF3 le '4') medhind=l.
if (MHF3 ge '6' and MHF3 le '12') medhind=l.
if (MHF3 ge T4 and MHF3 le 'IT) medhind=l.
if (MHF4 ge 1 and MHF4 le 4) medhind=l.
if (MHF4 ge 6 and MHF4 le 12) medhind=l.
if (MHF4 ge 14 and MHF4 le 17) medhind=l.
if (MHF5 ge 1 and MHF5 le 4) medhind=l.
if (MHF5 ge 6 and MHF5 le 12) medhmd-1.
if (MHF5 ge 14 and MHF5 le 17) medhind=l.
if (MHF6 ge 1 and MHF6 le 4) medhind=l.
if (MHF6 ge 6 and MHF6 le 12) medhind=l.
if (MHF6 ge 14 and MHF6 le 17) medhind=l.
if (CHRONIC=l) medhind=l.
missing values medhind (-1).
execute.
FORMATS medhind (F8).
VARIABLE LABELS medhind "medical history noted in this pregnancy indicator".
VALUE LABELS medhind
.000000000000000 "no medical history"
1.00000000000000 "medical history noted in this pregnancy".
FREQUENCIES
VARIABLE S=medhind
/ORDER ANALYSIS .


84
Dependent variables: (Please refer to Table 3.).
Low birth weight (LBW) was defined as birth weight greater than or equal to 500
grams and less than or equal to 2499 grams. All live births and fetal death records without
a recorded weight, a weight of less than 500 grams, or more than 5,500 grams (302
births/0.6%) were assigned to the missing values in the computations.
Table 3. List of All Variables Used in Analysis.
Dependent Variables
1. Low birth weight
2. Term low birth weight
3. Pre-term low birth weight
Independent Indicator Variables
1. Age <18, >40
2. Alcohol use from birth record
3. Alcohol use from Healthy Start screen
4. Birth interval short
5. Chlamydia positive
6. High school no-
7. Gonorrhea positive
8. Inadequate PNC indices
9. Inadequate weight gain
10. Married not
11. Medical history
12. Mistimed pregnancy
13. Mom foreign bom
14. Mom LBW
15. Prior poor pregnancy outcome
16. Race of mother black
17. Rural residence
18. Smoking from birth record
19. Smoking from Healthy Start
20. STDs, past or current
21. Stressfbl life


127
Table 12. Unadjusted Odds Ratios for Pre-Term Low Birth Weight, Based on Bi-variate
Analysis of Independent Variables in the Study Sample.
Variable name
OR
95% Cl
p value
1.
Age < 18, > 40
1.43
1.13,1.81
0.0032
2.
Alcohol use from birth record
1.32
0.61, 2.82
1.5195
3.
Alcohol use from Healthy Start screen
1.09
0.84,1.41
0.5156
4.
Birth interval short
1.23
0.98, 1.53
0.7690
5.
Chlamydia positive
1.86
1.14,3.02
0.0128
6.
High school no-
0.77
0.64, 0.94
0.0081
7.
Gonorrhea positive
1.74
0.54, 5.59
0.3551
8.
Inadequate PNC indices
1.41
1.17, 1.70
0.0003
9.
Inadequate weight gain
3.35
2.79, 4.03
0.0000
10.
Married not
1.54
1.26, 1.88
0.0000
11.
Medical history
1.57
1.21,2.04
0.0008
12.
Mistimed pregnancy
1.05
0.09, 1.26
0.5792
13.
Mom foreign bom
0.78
0.62, 0.98
0.0327
14.
MomLBW
1.41
1.08, 1.85
0.0126
15.
Prior poor pregnancy outcome
1.95
1.60, 2.38
0.0000
16.
Race of mother black
2.12
1.77, 2.55
0.0000
17.
Rural residence
0.90
0.74, 1.09
0.2708
18.
Smoking from birth record
1.22
0.98, 1.51
0.0657
19.
Smoking from Healthy Start
1.11
0.92,1.36
0.2810
20.
STDs, past or current
1.90
1.21, 2.99
0.0052
21.
Stressful life
0.90
0.71,1.15
0.3989
women, twice as many women with inadequate weight gain experienced low birth weight
events regardless of whether or not the inter pregnancy interval was short. Among women
who stated that the pregnancy was mistimed, 30% more black women had inadequate
weight gain. For women who stated that the timing of the pregnancy was acceptable, three
times as many white women had inadequate weight gain (this data not shown).
Fetal deaths were not equally distributed across body mass index (BME) groups;
women of normal BMI accounted for 52.3% of the 88 fetal deaths. Both term and pre
term low birth weight percentages were highest in women of low BMI, 3.6% and 4.2%


95
variable, the higher the m probability value. Probability of m is the probability that the
field agrees given the record pair is a match. This is one minus the error rate of that field.
The u probability is the probability that the field agrees given the record pair is
unmatched. An individual weight is computed for each comparison, and subsequently for
normalization, a composite weight is computed for the sum of the field as a logarithmic
value at base two of the ratio of m and u, e.g., log2 (m/u) (MatchWare Technologies, Inc,
1997).
Prior to attempting any record linkage the files must be standardized. For example
records must be a fixed size, with fixed fields and of a standard flat ASCII or database
type. Each data field that will be used for matching, blocking, and linkage must also be
standardized. For example date fields must be in year-month-day order, e.g., 19990704.
Missing values and zero values must be distinguishable below (MatchWare Technologies,
Inc, 1997). Names are separated into surname, first name and middle initials.
The many tests to one patient (mother) matching sequence is described to
better elucidate this phase of the analysis methodology:
1. Files A and B were evaluated separately for layout, fields were standardized, and data
dictionary lists created to identify each variable name, size and location.
The case morbidity files were selected for File A and the birth and fetal death
records for file B.
This step was supported by use of SOUNDEX and NYSUS, both registered software
used to support record linkage, to standardize name, street 1, street2, city, state, and
zip on the case morbidity file. This was followed by standardization of fathers name,
mothers address, and mothers city on the birth fetal death record file.


55
of 35 and 49 whose rates were from 9.6% to 8.9% (Hemminki & Gissler, 1996). Their
findings in a different population are consistent with much of the epidemiologic data in this
country and suggest that the resulting social stigmata and subsequent increased risk for
lifetime poverty are greater risk factors for the adolescent compared to the older women
for whom the low birth weight event is a greater risk Lee and colleagues (1988) examined
birth records from Illinois for the years between 1980 and 1984. After controlling for race,
education, parity, prenatal care, and marital status they concluded that the adjusted risk for
low birth weight at term is lowest among teens and increases with advancing maternal age.
Childbearing at an older age in this country is associated with higher rates of low
birth weight. For 1996, 8.1% of births to women aged 35-39 were less than 2,500 grams,
9.5% to women aged 40-44 years, and 14.9% to women 45-49 years of age (Ventura,
Martin, Curtin, & Mathews, 1998). The rate for women of black race/ethnicity is even
more pronounced at advanced childbearing ages: 16% for women 35-39 years, 18.4% for
women aged 40-44, and 18.2% for those 45-49 years. Lee (1988, as cited by Committee
on Unintended Pregnancy, 1995) suggests that this association may be linked to biologic
aging of maternal tissues and systems, or the accumulative effects of diseases e.g.,
hypertension, diabetes.
The epidemiology of LBW and the literature suggests that black race/ethnicity is
disparately associated with LBW, as well as PTLBW and PROM. Virji and Cottington
(1991) observed that black women experienced a significant risk for PTL, (adjusted OR
1.56). Others reported an odds ratio of 2.1 for PTL among both black and Hispanic
women (Berkowitz, Blackmore-Prince, Lapinski, & Savitz, 1998). Collins and David
(1990) examined race and the differential effect of income, education, marital status, and


94
Methods of Analysis
Development of relational database .The preliminary step performed to support the
analysis was the matching of the above-described administrative databases to create a
single relational database. The birth and fetal death records were identified as the base file
to which all other files were matched. This file was selected because it was the largest; it
also offered a unique identifier for a linkage key. Each administrative database was
sequentially matched supported by AUTOMATCH, as explained in more detail below
(MatchWare Technologies, Inc, 1997). Once the matched records were identified a
relational study database was created in ACCESS linked by the birth fetal death certificate
number (Microsoft, 1997).
AUTOMATCH is a generalized record linkage system software that supports
individual record matching, geographic coding, many-to-one matching single file
grouping, and unduplication of records through probabilistic estimating techniques. This
study utilized the many-to-one and the individual record matching functions of the
software. Individual record linkage involves the use of two files, A and B to locate
records that belong to the same individual despite missing or incorrect information. This
allows one to use administrative files to find missing data and create a more
comprehensive data set about individual persons. Many-to-one matching is similar to the
individual record linkage but allows for matching of one set of independent records to any
of the records contained in the other file (MatchWare Technologies, Inc, 1997).
Variables are selected for the match specifications based on reliability and
statistical values and their distribution. Probability estimates are calculated for match (m)
and unmatch (u) based on analysis of the frequency of occurrence. The more reliable a


61
Herpes simplex virus is not associated with low birth weight, and generally is
believed to be transmitted intra-partum (Stagno & Whitley, 1999). It is associated with
pre-term labor and spontaneous abortion and both primary and recurrent infection can
cause fetal infection in tero. The sequelae that can accompany infection range from skin
vesicles, blindness, disseminated infection, and long term neurological impairment and
most often are lethal. The authors of the NIAID Collaborative Antiviral Study (as cited in
Stagno & Whitley, 1999) reported in their data that 33% of those with disseminated
infection, 23% of those with central nervous system infection, and 24% of those with skin,
eye or mouth infection were delivered before 36 weeks.
Intra pregnancy infection with Neisseria gonorrhoeae has been studied by several
groups as reported in Gutman (1999) and Morse and Beck-Saque (1999). The rates for
premature delivery were between 13% and 67%; however, no mention is made in Gutman
of the infants birth weights or association with term low birth weight, or small for
gestational age infants. Other adverse outcomes reported, include spontaneous abortion,
perinatal death, perinatal distress, stillbirth, chorioamnionitis, premature rupture of the
membranes, skin and joint lesions, and meningoencephalitis (Watts & Branham, 1999).
The reported association of gonorrhea with pre-maturity has been conflicting. Amstey
(1976, as cited in Gutman, 1999) reported the rates of poor outcomes in his study were
the same, regardless of treatment during pregnancy. Amsteys high rates of pre-maturity
were not found by Charles et aL (1970 as cited in Watts & Branham, 1999). One serious
sequelae is an association between pregnancy and disseminated gonoccocal infection, a
condition that usually requires hospitalization to adequately treat.


137
Table 15. Adjusted Odds Ratios, Based on Logistic Regression, without Race Variable.
Low Birth Weight
Variable
OR
95% Cl
p value
Alcohol use from birth record
2.02
1.29,3.16
0.0022
High school graduate not
0.82
0.68, 1.00
0.0438
Inadequate weight gain
2.63
2.29, 3.03
0.0000
Married not
1.45
1.25, 1.69
0.0000
MomLBW
1.53
1.26, 1.87
0.0000
Prior poor pregnancy outcome
1.87
1.61,2.19
0.0000
Smoking from birth record
1.48
1.27, 1.74
0.0000
STDs, past or current
1.70
1.20, 2.41
0.0029
Term Low Birth Weight
Variable
OR
95% Cl
p value
Age < 18, >40
1.50
1.12, 2.02
0.0066
Alcohol use from birth record
2.23
1.23, 4.05
0.0086
Alcohol use from Healthy Start screen
1.38
1.04, 1.84
0.0276
Birth interval short
0.73
0.55, 0.99
0.0411
Inadequate PNC indices
1.30
1.05, 1.63
0.0185
Inadequate weight gain
2.58
2.07, 3.21
0.0000
Married not
1.27
1.01, 1.61
0.0456
MomLBW
1.91
1.44, 2.55
0.0000
Prior poor pregnancy outcome
1.93
1.51,2.47
0.0000
Smoking from birth record
1.83
1.44, 2.33
0.0000
STDs, past or current
2.01
1.21, 3.36
0.0075
Pre-Term Low Birth Weight
Variable
OR
95% Cl
p value
High school graduate not
0.68
0.55, 0.82
0.0001
Inadequate PNC indices
1.26
1.04, 1.53
0.0181
Inadequate weight gain
3.40
2.82, 4.11
0.0000
Married not
1.52
1.24, 1.86
0.0001
Medical history
1.42
1.09, 1.87
0.0105
MomLBW
1.40
1.06, 1.84
0.0181
Prior poor pregnancy outcome
1.97
1.60, 2.41
0.0000
STDs, past or current
1.65
1.03, 2.62
0.0362


78
Gen-Probe PACE2C database that met the time, test, and gender study parameters. Each
woman and infant had two records, one for chlamydia results and a second for gonorrhea
results. This data set provided key variables for the final study database, as are presented
in Appendix A.
Maternal and infant case morbidity database. The maternal and infant case
morbidity database is the fifth source from which study files were extracted. Sporadic
reporting of venereal diseases by providers to the authorities dates to 1918. By 1920 the
numbers of venereal diseases reported exceeded the total of the next three causes of illness
(Hardy & Pychon, 1964). In 1921 the Bureau of Venereal Diseases faded into the Bureau
of Communicable Diseases and it was not until 1938 that funds w ere appropriated to
support reporting again. Prior to World War II (in 1944) Florida saw the establishment of
a central registry for syphilis (Brink, 1944). That same year the Legislature enacted
prenatal and premarital serology for syphilis. The present centralized computer dates to
1988 and contains records of458,771 case reports for syphilis, chlamydia, gonorrhea,
chancroid, lymphogranuloma venereum, and since 1997, human immunodeficiency virus
(K. Kampert, personal communications, June 30, 1999). The maternal and infant case
morbidity data set was extracted from this existing STD Case Morbidity Reporting
database housed in the Florida Department of Health, Bureau of STD Prevention and
Control, Tallahassee, Florida.
The details of a STD case report travel through numerous hands before actually
entering the system, defined as a case. At the onset a suitable specimen suspicious of a
STD must be collected and forwarded to a laboratory for testing. Laws and regulations
require that laboratories and physicians both must report all positive tests diagnosing a


98
and the indicator variables. The results of these cross tabulations were entered into a
spreadsheet to test for significance and calculate the unadjusted odds ratios for each
indicator variable. Uni-variate and multivariate analysis was supported by Statistical
Package for Social Sciences 9.0 (SPSS Inc, 1999). Additionally, bi-variate tests for
significance and calculation of unadjusted odds ratios was supported by Microsoft Excel
97. Statistical significance was sought at the p value < 0.05 and 95% confidence intervals.
Logistic regression. Multivariate analyses of selected variables was used to further
explore the association between LBW, chlamydial infection, and to select potentially
confounding variables. Variables found statistically significant in the bi-variate analysis
were placed into various selection models: enter, forward stepwise selection, and
backward stepwise elimination. Variables initially entered into the desired models are
removed based on different statistical tests: Wald, change in likelihood or conditional
statistic. Initial exploratory examination of the variables with the available logistic models
and use of the various statistical criteria suggested that the backward elimination model
utilizing the likelihood-ratio test was the most suitable for use in the study sample.
Additionally, the backwards elimination model allowed for observation of which variables
were eliminated at identified levels of significance, and provided useful insight into the
discussion on the findings for sub-groups within the study sample in relation to the study
question. All analysis was supported by Statistical Package for Social Sciences 9.0 (SPSS
Inc, 1999). Statistical significance was sought at the p value < 0.05 and 95% confidence
intervals.


114
noted for those having completed 12 years of school No information is available in the
birth and fetal death records regarding the percent of women who did not graduate, and
then went on to receive a GED.
All women in the study sample received their prenatal care from the county health
department (CUD), while 8.9 percent of the general population were identified as having
received their care at the CHD and 24% received their prenatal care from a private
provider. Based on the information from the linked prenatal screens, Medicaid was the
source of insurance coverage for more than two thirds of women in the study sample, and
slightly more than one third for those in the general population. More than a quarter had
no insurance coverage in the study sample at the time the screen was completed. Please
refer to Table 6.
There were two variables available to measure the percent of women initiating care
in each trimester of pregnancy. The first option and one field common to all records, but
not necessarily completed, is from the birth and fetal death record: the month prenatal
care began. The actual trimester of entry date must then be computed from the date in
this field and the reported date of birth or death. It is possible that maternal recall bias may
affect the accuracy of this date. This investigator did not perform this computation within
the context of this study. However, the Office of Vital Statistics (1997) reported that
82.3% received prenatal care in the first trimester. Among adolescent females aged 15-19
years, 6.3% received no prenatal care or not until the third trimester, compared to 81% of
those under age 15 years.
The second option to identify trimester of entry into care was contained in the
Healthy Start prenatal screen field: Trimester of pregnancy at first prenatal visit. This


14
Martens, Young, Uribe, Buttram, & Faro, 1993). Reported recovery from women
examined by laparoscopy has ranged from 10% to 80%, with secondary bacteria
recovered much less frequently. More often in clinically milder or silent FED, chlamydia
is recovered or there is immunologic evidence of recent infection with Chlamydia
trachomatis (Patton et aL, 1994). Tubal scarring and development of tubal infertility
follow the acute or silent P1D. This same scarring can set the stage for later life
threatening ectopic pregnancy events. Moore and Cates (1990) suggest that infertility may
follow either acute or clinically detected PID and silent salpingitis. They and others
provide ample evidence to suggest that the majority of tubal factor infertility follows
events of silent salpingitis, in woman who report no history of PID but demonstrate
serologic evidence of prior chlamydial infection (Cates & Wasserheit, 1991; Patton et aL,
1989; Westrom, 1975, 1994; WHO, 1995). In contrast the Wolner-Hanssen (1995) in-
depth study using laproscopy and questionnaires suggests that silent PID is secondary to
the failure of the medical community to elicit more complete information from a patient
regarding their menstrual history, abdominal pain, and episodes of infection. The author
does not suggest that chlamydia is not associated with PID, merely that the silent or
atypical status of the PID experienced by women is likely overstated and a result of failure
to elicit complete medical histories.
Studies conducted among pregnant women have identified rates of less than 6% to
close to 33% infected depending on the age, clinic setting, and area of residence. Allaire
and others found a rate of 14.8% among a high-risk indigent obstetric population using
both rNA hybridization and enzyme immunoassay (1998). Nearly 21% prevealce was
reported by researchers who studied an adolescent pregnant group using immunoassay


158
Analysis and Discussion of Research Findings
This retrospective epidemiologic study identified a significant statistical association
between chlamydial infection during pregnancy, and low birth weight, and pre-term low
birth weight. The findings are the result of analysis conducted on a large sample size
(14,002 records) of retrospectively gathered information, and is not a statement of cause
and effect relationship, or direction of sequence of events. The study findings are robust,
considering the significant number of other factors reported to increase the risk for low
birth weight that were controlled for in the logistic regression models. The substantial
associations observed in the final two logistic regression models will be discussed in more
detail, along with other associations observed, in the initial four models.
The finding of significant associations in this study between chlamydial infection
during pregnancy and low birth weight, add further evidence to the body of earlier work
reported by Ryan et al, Gencay et aL, Gravett et al., and Martius et aL as discussed
earlier. Additionally, this is the second study conducted among pregnant women who
received their prenatal care in county health departments to identify a strong association
between low birth weight and Chlamydia trachomatis.
The descriptive analyses highlighted differences and similarities between the study
population and the statewide birth and fetal death cohort for 1996. The rate of low birth
weight was less at 6.9% compared to 8.1%. The term low birth weight rate was slightly
higher (2.6%, 2.4%) and the pre-term low birth weight rate was also lower at 3.5%
compared to 4.8%. Fewer women in the study sample were infected with chlamydia than


234
if (GCRESULM eq 1) STDindic=l.
if (V220 ge 200 and V220 le 730 ) STDindic=l.
if (DIAGNOSI le 790) STDindic=l.
if (CTlabinf eq 1) STDindic=l.
if (MHF1 eq' 5') STDindic=l.
if (MHF2 eq '05') STDindic=l.
if (MHF3 eq '05') STDindic=l.
if (GClabinf eq 1) STDindic=l.
missing values STDindic (-1).
execute.
FORMATS STDindic (F8).
VARIABLE LABELS STDindic "mom or infant with current or past STDs''.
VALUE LABELS STDindic
.000000000000000 "STD negative mom or infant"
1.00000000000000 "STD positive mom or infant"
execute.
FREQUENCIES
VARIABLE S= STDindic
/ORDER ANALYSIS.


93
value of 1 was assigned to any record with a yes code in any of these fields sought.
Neither data set clarified if the recorded abortions were spontaneous or induced; therefore,
this field was excluded.
Smoked during pregnancy and smoked in the last two months, like the risk
variables for alcohol, which do not allow for clarification that the use of cigarettes or other
forms of tobacco use took place prior to the onset of pregnancy, were discontinued as a
result of personal motivation or smoking cessation classes. Considered alone, the
information from this variable also does not provide clear information on the number of
cigarettes smoked each day or frequency of tobacco use throughout the pregnancy. Both
of these variables, as with alcohol, provide only a crude measure of the risk associated
with tobacco use during pregnancy. Smoking continues to be reported in the literature as
having a strong association with LBW. Conversely, researchers report reduction in the
risk for small-for-gestational-age births subsequent to decreases in tobacco exposure
during pregnancy (Cnattingius & Haglund, 1997).
Stress identified in mother's life combines several potential psychosocial stressors
that may necessitate some degree of adaptive or coping behaviors by the pregnant woman.
A yes response to any of the following stress related life situation computed a score of
1 for a women for the purposes of this variable: 1) no insurance coverage, 2) problems
keeping appointments, 3) moved more than three times in last 12 months, 4) felt unsafe, 5)
someone in household goes to bed hungry, 6) physical violence, and 7) stress level of
medium or high.


53
Marked differences were also noted for utilization with multiple gestations as reported by
the different indices ranging from a -13% to 23%.
Perloff and Jaffee (1997) compared two measures to examine the utilization of
prenatal care in New York City. The most interesting finding they reported was the
marked differences in sample characteristics that the two indices produced. The magnitude
of risk for inadequate care among blacks, teens, those women not completing high school,
and unmarried women is significantly increased with the use of the APNCUI indices.
Kogan, Alexander, Kotelchuck and Nagey (1994) looked at the content of prenatal
care and its association with LBW. They utilized the Kessner Index to measure adequacy
of prenatal care utilization and controlled for other risk factors such as age, education,
employment status, smoking, etc, and examined interaction terms in their logistic
regression models. Women in this study who did not report receiving all types of advice
recommended by the Expert Panel on the Content of Prenatal Care were more likely to
have a LBW infant (OR 1.38). The authors found no differences between women who
reported that they received all the recommended initial prenatal care procedures, and those
who reported not to have received all prenatal care procedures. With the discrepancies
observed in the above reviews of the different indices the risk associated between LBW
and inadequate care in this and other studies must be interpreted with caution.
Very young age appears to be associated in some studies with LBW and also late
initiation into prenatal care. Higher rates of LBW have also been observed for women
over forty. For adolescents aged 15-19 the rate of LBW in 1997 nationally was 13.6%,
and for women over forty, the rate was 10%, while the overall rate was 7.5% (Ventura,
Martin, Curtin, & Mathews, 1998). Among all women nationally, the percent that entered


133
Table 14. Adjusted Odds Ratios, Based on Logistic Regression, for all Variables.
Low Birth Weight
Variable
OR
95% Cl
p value
High school graduate not
0.83
0.69, 1.00
0.0489
Inadequate weight gain
2.52
2.19, 2.91
0.0000
Married not
1.21
1.03, 1.42
0.0177
MomLBW
1.49
1.22, 1.82
0.0001
Prior poor pregnancy outcome
1.81
1.55, 2.12
0.0000
Race of mother black
1.89
1.62, 2.20
0.0000
Smoking from birth record
1.74
1.47, 2.07
0.0000
STDs, past or current
1.48
1.04,2.11
0.0278
Term Low Birth Weight
Variable
OR
95% Cl
p value
Age < 18, >40
1.49
0.11, 1.99
0.0080
Alcohol use from Healthy Start screen
1.43
1.07, 1.90
0.0157
Birth interval short
0.73
0.55, 0.99
0.0400
Inadequate PNC indices
1.31
1.05, 1.63
0.0176
Inadequate weight gain
2.46
1.97, 3.07
0.0000
MomLBW
1.86
1.40,2.43
0.0000
Prior poor pregnancy outcome
1.86
1.46, 2.39
0.0000
Race of mother black
1.86
1.47, 2.34
0.0000
Smoking from birth record
2.17
1.69, 2.80
0.0000
STDs, past or current
1.79
1.07, 3.00
0.0269
Pre-Term Low Birth Weight
Variable
OR
95% Cl
p value
High school graduate not
0.68
0.56, 0.84
0.0002
Inadequate PNC indices
1.26
1.04, 1.53
0.0171
Inadequate weight gain
3.31
2.74, 4.00
0.0000
Married not
1.24
1.00, 1.54
0.0468
Medical history
1.44
1.10, 1.89
0.0081
MomLBW
1.36
1.03, 1.79
0.0308
Prior poor pregnancy outcome
1.91
1.55, 2.34
0.0000
Race of mother black
2.03
1.65, 2.50
0.0000
Smoking from Healthy Start screen
1.45
1.17, 1.80
0.0007


147
Table 18. Adjusted Odds Ratios, Based on Logistic Regression, for Inadequate Weight
Gain.
Low Birth Weight
Variable
OR
95% Cl
p value
Alcohol use from birth record
2.36
1.19, 4.72
0.0146
Chlamydia positive
1.98
1.12,3.51
0.0184
High school graduate not
0.66
0.52, 0.84
0.0008
Married not
1.37
1.06, 1.78
0.0182
MomLBW
2.07
1.54, 2.79
0.0000
Prior poor pregnancy outcome
1.96
1.53, 2.50
0.0000
Race of mother black
1.51
1.17, 1.95
0.0014
Smoking from Healthy Start screen
1.76
1.37, 2.27
0.0000
Term Low Birth Weight
Variable
OR
95% Cl
p value
Alcohol use from birth record
3.62
1.57, 8.38
0.0026
High school graduate not
0.63
0.43, 0.92
0.0178
Medical history
0.48
0.24, 0.97
0.0412
Mistimed pregnancy
1.75
1.21, 2.54
0.0029
Mom LBW
2.93
1.94, 4.40
0.0000
Prior poor pregnancy outcome
2.19
1.51,3.19
0.0000
Race of mother black
1.61
1.11,2.33
0.0119
Smoking from birth record
2.35
1.58, 3.51
0.0000
Pre-Term Low Birth Weight
Variable
OR
95% Cl
p value
Chlamydia positive
234
1.23, 4.48
0.0099
High school graduate not
0.64
0.48, 0.87
0.0040
Married not
1.61
1.16, 2.24
0.0046
Prior poor pregnancy outcome
1.90
1.40, 2.57
0.0000
Race of mother black
1.58
1.16, 2.15
0.0037
Smoking from Healthy Start screen
1.67
1.22, 2.29
0.0014


7
transmit the infection to the fetus in tero. Tertiary syphilis may occur at any time during
latency and congenital transmission at this stage is rare.
LCR is a brand name for ligase chain reaction, which is based on polymerase
chain reaction, a DNA amplification technology.
Low birth weight (LBW1 is the term used to indicate a live bom infant whose
weight is less than 2,500 grams.
Pooling is the term used to indicate a testing methodology where a portion of
multiple specimens are combined in a single vial and all are tested simultaneously. If
negative, all are reported out as negative. If the pooled result is positive, then each
specimen must be further tested individually to identify the positive specimen. In
populations with low prevalence, pooling is a cost saving procedure that conserves
reagents. It is not useful in populations with high prevalence of infection.
Pre-term low birth weight PTLBW1 is the term used to indicate a live bom infant
whose weight is less than 2,500 grams and less than 37 weeks gestation.
Sensitivity of a test as used in this study, is the probability of the Gen-Probe test
to report a positive test in an individual truly infected with Chlamydia trachomatis or
Neisseria gonorrhoeae.
Serology is the term used to indicate a laboratory test technique using blood
serum for testing. This is also commonly used to indicate a syphilis blood test.
Serovars of Chlamydia species appear to be associated with different levels of
immune response and virulence in the human host.


32
Release ai 48-72 hours of
as many as 100-1,000
elementary bodies.
1. Rupture
2. Fission
3. Disintegration
Initial host cell
Host invasion at 5 minutes
with vacuole
internal izati
Reorganization at
18-24 hours of
reticulate bodies to
elementary bodies;
some continue
binary fusion; one
can also observe
intermediate
forms.
Loss of rigid cytoskeleton
and formation into the
permeable inclusion body
with rapid relocation to
close proximity of Golgi
apparatus at 10 minutes.
Binary fusion of
reticulate body at 8-
18 hours.
Maturation of elementary
body to reticulate body at
4 -8 hours.
Content adapted from Schachter, 1999a, Wyrick, 1998; Schachter, 1995; Wentworth, Judson & Gilchrist,
1991; Patton, Cummings, Cosgrove, Yvonne, & Kuo, 1998; Martin, 1990; Neeper, Patton, & Kuo, 1990;
Fedorko & Smith, 1991; Beatty, Momson, & Byme, 1994.
Figure 3. The Developmental Cycle of Chlamydiae.


101
laboratory database. Failure of hardware contributed to corruption of data files. Months of
data for 1996 were permanently lost secondary to an inadequately designed archival
system. This factor, combined with the staged implementation of the computerized
laboratory system, reduced the number of laboratory test results available for matching.
The third limitation relates more to the study design. The data utilized in this study
were gathered retrospectively from existing databases rather than prospectively in a
specifically designed study. As a result, undetected bias may be present in the data.
Undetected bias may also be present in data as a result of the matching processes and
incompatible demographic data that precluded complete matching of records.
Each of the study database files was developed independently of the others. As a
consequence, there are significant differences that hampered the construction and the
subsequent analyses. Some differences could be remedied relatively easily, like the
standardization of certain fields before the matching processes began. Other initially
important differences in the data quality added impediments to the analysis stage. For
example, the Department of Health presently supports three different sets of county
coding within the various database systems.
Examination of the distribution of counties from which patients were included at
the preliminary analysis of the case morbidity file, suggested that there were an excessive
number of syphilis cases from several rural counties. A close scrutiny showed that the city,
zip code, and clinic where services were provided were all located in Dade County. The
codes used were correct for the county health department system, but not for the
STD*MIS system, yet both systems accept the numbers as valid. A similar observation


120
Additional information is contained in the relational database that was useful in
establishing an overall understanding of the population from which the study sample was
extracted. Some of the more notable are included in the next chapter regarding sexually
transmitted infections. Other data, while vast and of enduring interest, is alas, beyond the
scope of this study and the limits of time accompanying it.
Descriptive Comparison of the Dependent and Independent Variables
Three dependent variables were used for the bivariate and logistic analyses. A
comparison of these and the independent variables for both the general population and the
study sample are presented in Tables 8 and 9. The study sample had a lower rate of low
birth weight than that of the total birth and fetal death group (6.9% and 8.1%
respectively). This number differs from the published rates in two ways. First it includes
the weights of fetal death records linked to the birth records. The weight of recorded fetal
deaths is not published in the annual state report on population, births, deaths, marriages
and dissolutions of marriage (Office of Vital Statistics, 1997). Second, it is possible that
some difference may result from the commuted dependent variables. The parameters are
presented in Table 8 and in the definitions presented on prior pages. The percent of pre
term low birth weight is also lower in the study sample (3.5%) compared to the statewide
low birth weight rate (4.8%).
Table 9 presents a comparison of the distribution of the created indicator variables
between the total relational database group and the study sample. Definitions and
descriptions of the calculations for these variables appear on pages above and in the syntax
presented in Appendix B.


13
75% are asymptomatic when infected (Schmitt, 1999). Nationally, the reported
asymptomatic rate ranges from 50-75% (Cates & Wasserheit, 1991). Following exposure
and infection, symptoms may begin within 1 to 2 weeks. Females generally present with
cervicitis however urethritis is also common. Asymptomatic infection of the rectum or
urethra may accompany symptomatic infection of the cervix up to 50% of the time (Cates
& Wasserheit, 1991; Stamm, 1999). Many women will have only mild symptoms of
vaginal discharge, spotting, lower abdominal pain, or dysuria. Infection may also present
as salpingitis, endometritis, peritonitis, Bartholinitis, perihepatitis, pharyngitis, and reactive
arthritis. Adults, like infants, can present with conjunctivitis and cases of myocarditis have
been reported (Stamm & Holmes, 1990; Freund, 1992; Bergstrom & Libombo, 1995;
Berman et aL, 1987; Grayston, Mordhorst, & Wang, 1981; Kessler, Pierer, Stuenzner,
Auer-Grambach, Haller, & Marth, 1994).
The natural history of the infection in a nonpregnant woman is one initially of
cervicitis, with ascent to cause salpingitis, sometimes having first caused endometritis en
route. Without treatment, one-fourth to one-half of women with chlamydia will go on to
develop pelvic inflammatory disease (PID), involving inflammation of the endometrium,
fallopian tube(s), and potential involvement of the peritoneum Rates of identification of
Chlamydia trachomatis by culture, antigen, or serology in cases of salpingitis and P1D
range from 5 to 55% depending on the clinic setting, geographic site, type technology and
country (Cates & Branham, 1999; Schachter, 1999a). The leading hypothesis for PDD
pathogenesis is that endometrial and Chlamydia trachomatis and Neisseria gonorrhoeae
initiate tubal infection. Then secondary groups of anaerobic and aerobic bacteria may
invade to contribute to the inflammatory disease process (Cates, Rolfs, & Aral, 1990;


70
later reported also as a fetal death. Monitoring steps are designed to identify inappropriate
registration combinations of certificates for the individual live bom infant or stillborn
infant. This combined data set provided key variables for the final study database, and are
presented in Appendix A. It also served as the base file against which all other files were
matched and linked to in the final relational study database.
Healthy Start prenatal screen database. The Healthy Start prenatal screen is the
third database from which study files were extracted. In 1991, the Florida Legislature
enacted the Healthy Start program with the creation of Chapter 383.2161 of the Florida
Statutes and development of Chapter 64C-7, Florida Administrative Code. Implemented in
April 1992, this program was modeled on prenatal case management programs in other
states like South Carolina and international studies that demonstrated the value of non
medical interventions for women and infants at risk of low birth weight, infant death, and
developmental delay (Thompson, 1993; Florida Department of Health, 1997b). The core
components of Healthy Start include: 1) universal screening of all pregnant women and
newborns, 2) professional assessment of health, social and environmental risks, and 3)
targeted case management and risk appropriate care. Expanded Medicaid eligibility to
185% of the federal poverty level, and provider reimbursement to providers to administer
the prenatal screens further support the Healthy Start program goals of improved
pregnancy outcomes (Florida Department of Health and Rehabilitative Services, 1995).
First trimester screens are reimbursed at a higher rate in support of timely intervention
(Florida Department of Health, 1998).
The Healthy Start prenatal screen data set was extracted from an existing system
database housed in the Florida Department of Health, Office of Vital Statistics,


88
examined the association between low birth weight and the interval between pregnancies,
reporting that the LBW increases markedly at IPI of less than 9 months (Thompson,
1995). In the second study, the inter pregnancy interval was calculated from the date of
the last menses and the date of the last live birth, both of which were taken from the birth
record. This calculation was utilized for the indicator variable with a value of 1 given to
those women with the designated risk of a birth interval less than 9 months.
Body mass index group was calculated in numerous steps based on the following
formula: weight [kilogramsj/height [meters]2 (Abrams & Parker, 1990; Anderson,
Anderson, & Glanze, 1994). Initially, the weight in pounds before pregnancy from the
Healthy Start prenatal screen file was converted to kilograms. The height in feet and
inches was then converted to height in meters. In the next step the weight in kilograms
was divided by the height in meters squared to assign a body mass index value to each
woman. The calculated score placed a woman in an underweight, normal weight,
overweight, or obese category according to published standards for pregnancy BMI
(Florida Department of Health, 1999).
Chlamydia positive and Gonorrhea positive were both taken from the Gen-Probe
PACE2C test results contained in the laboratory data file. Only those test results
designated either positive or negative, were used in the analysis. All results designated
indeterminate or unsatisfactory were assigned to missing for clarity of interpretation.
High school graduate was calculated from information on the mothers highest
level of education completed contained on the birth record, grouped as having not
completed high school, having competed 12 years of education and as having completed
more than 12 years. For the logistic regression analysis, women with an age of equal to or



PAGE 1

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213
Appendix A. Variables List.
Original
Variable Name
New Variable
Name
Variable labels
D R
D R
record number
CDOBM
CDOBM
childs dob month
CDOBD
CDOBD
childs dob day
CDOBY
CDOBY
childs dob year
BFNUMBER
BFNUMBER
bfnumber
CERT NO
CERT NO
cert no
CSEX
CSEX
childs gender
CRACE
CRACE
childs race
PLURAL
PLURAL
plural birth
APGAR1
APGAR1
apgar score at 1 minute
APGAR5
APGAR5
apgar score at 5 minutes
BW
BW
birth weight
MRACE
MRACE
moms race
MMS
MMS
moms marital status
MED
MED
moms educational level
MAGE
MAGE
moms age
MB ST
MB ST
moms state of birth
MRCNTY
MRCNTY
moms county of residence
MRLIM
MRLIM
moms lives within city limits
STATE
STATE
moms state
MDOBM
MDOBM
moms dob month
MDOBD
MDOBD
moms dob day
MDOBY
MDOBY
moms dob year
MHSIP
MHSIP
dads hispanic ethnicity
FAGE
FAGE
dads age
FBST
FBST
dads state of birth
FRACE
FRACE
dads race
FED
FED
dads educational level
FDOBM
FDOBM
dads dob month
FDOBD
FDOBD
dads dob day
FDOBY
FDOBY
dads dob year
FHISP
FHISP
dads hispanic ethnicity
ESTGEST
ESTGEST
estimated gestation
TOBUSE
TOBUSE
tobacco use during pregnancy?
CIGS
CIGS
average number of cigarettes per day
ALCUSE
ALCUSE
alcohol use during pregnancy?
DRINKS
DRINKS
average number of drinks per week
WTGAIN
WTGAIN
wei$it gained during pregnancy
MHF1- 17
MHF1-17
medical history factors for this pregnancy
MODI
MODI
vaginal delivery
MOD2
MOD2
vaginal delivery post prior c-section
MOD3
MOD3
primary c-section delivery
MOD4
MOD4
repeat c-section delivery
MOD5
MOD5
forceps delivery
MOD6
MOD6
vacuum delivery
PRENL
PRENL
number of live births now living
PREND
PREND
number of live births now dead
LLBM
LLBM
month of last live birth
LLBY
LLBY
year of last live birth


6
EIA. enzyme immimoassay, is one of the earlier non-culture tests for chlamydia.
This method detects chlamydial antigens measured by enzyme-linked immunoassay with
polyclonal or monoclonal antibodies.
Fetal growth restriction or retardation is defined as a birth weight and height
below the 10th percentile for a specific gestational age. Another term that is often used
interchangeably is small for gestational age.
Gonorrhea is the common term used to refer to Neisseria gonorrhoeae, a gram
negative intracellular diplococcus, predominantly sexually transmitted, and capable of
causing long-term adverse sequelae when untreated.
Inadequate specimen indicates a Gen-Probe test specimen that does not contain
enough cellular material to test for the presence of Chlamydia trachomatis or Neisseria
gonorrhoeae.
Indeterminate is a term used to report specimens that do not fell distinctly within
the parameters used to measure relative light units on Gen-Probe testing equipment. This
may indicate a specimen that is a false negative, a false positive, or a specimen that had
inadequate quantity on which to complete the confirmatory test.
I.ate syphilis is a term used to refer to the period of syphilis infection that
continues after the cessation of clinical manifestations and symptoms, associated with
primary and secondary syphilis infection. The organism, T. Pallidum, is still present,
primarily in the spleen and lymph nodes. Early latent syphilis spans the period of the first
year of infection. Late latent begins one year after infection, and may last a life time. As
during primary and secondary syphilis, a pregnant woman with latent syphilis can


233
execute.
FREQUENCIES
VARIABLE S= BMrace
/ORDER ANALYSIS .
To recode infant birthrace for CUD sample file
compute BCrace=CRACE.
recode Bcrace (1=1) (2=2) (else=0).
missing values BCrace (-1).
FORMATS BCrace (F8).
VARIABLE LABELS BCrace ,rbirth infant's race (CHD)".
VALUE LABELS BCrace
.000000000000000 "other"
1.00000000000000 "white"
2.00000000000000 "black".
execute.
FREQUENCIES
VARIABLES= BCrace
/ORDER ANALYSIS.
To capture HSV for STD now or in past indicators for mom and infant
compute hsvl=0.
if(MHFl eq '05')hsvl=l.
missing values hsvl (-1).
execute.
compute hsv2=0.
if(MHF2 eq ,05')hsv2=l.
missing values hsv2 (-1).
execute.
compute hsv3=0.
if(MHF3 eq'05')hsv3=l.
missing values hsv3 (-1).
execute.
FORMATS hsvpg (F8).
VARIABLE LABELS hsvpg "mom or infant with current or past STDs".
VALUE LABELS STDindic
.000000000000000 "no HS identified"
1.00000000000000 "STD positive mom or infant"
execute.
FREQUENCIES
VARIABLES= hsvl hsv2 hsv3
/ORDER ANALYSIS .
compute STDindic=0.
if (CTRESULM eq 1) STDindic=l.


219
For a trial run on gestational categories matched to birth weight.
compute LBWGGest=0.
if (BWG eq 1 and gweeks ge 37) LBWGGest=l.
if (BWG eq 1 and gweeks le 36) LBWGGest=2.
if (BWG eq 2 and gweeks le 36) LBWGGest=3.
missing values LBWGGest (-1).
FORMATS Ibwggest (F8).
VARIABLE LABELS Ibwggest "lbw and gest age".
VALUE LABELS Ibwggest
.000000000000000 "TNBW >2500 > 37 weeks"
1.00000000000000 "TLBW >1500 <2499 >37 weeks"
2.00000000000000 "PTLBW >1500 < 2499 <36 weeks"
3.00000000000000 "PTVLBW >500 <1499 < 36 weeks".
FREQUENCIES
VARIABLE S=Ibwggest
/HISTOGRAM NORMAL
/ORDER ANALYSIS .
To create the birth interval indicator variable.
I settled on the nine months from last pregnancy to current birth LMP, since we have
paper on analysis to support this in our population, and actually this is closer to the two
years of universal standard, since on to the 9 months you add 9 months gestation on to
that and reach close to 18 months.
compute LLBdays=0.
compute LLBD=15.
compute LLBdays=(LLBY*365.25) + (LLBM*30.4375) + LLBD.
missing values LLBdays (-1).
compute DOTdays=0.
compute DOTD=15.
compute DOTdays=(DOTY*365.25) + (DOTM*30.4375) + DOTD.
missing values DOT days (-1).
compute lastpreg= LLBdays.
if (DOTdays GT LLBdays) lastpreg = DOTdays.
compute birthint= (LMPdays)-(lastpreg).
missing values birthint (-1).
compute Blindic=0.
if (birthint LT 273.9375) BIindic?=l.
missing values Blindic (-1).
VARIABLE LABELS LLBdays "last live birth total days" LLBY "last live birth year"


16
period from rupture of membranes to delivery (Ismail, Pridjian, Hibbard, Harth, &
Moawad, 1992). Chlamydia was identified by amniocentesis from a case of induced labor
secondary to suspected chorioamnionitis (Thomas, Jones, Sbarra, Cetrulo, & Reisner,
1990). The cervical specimen was culture positive for Chlamydia trachomatis, Candidia
albicans, U urealyticum, and group B streptococci. Chlamydial elementary bodies were
identified by fluorescent stain in both amniotic fluid and placental tissue specimens
suggesting that only these organisms ascended from the lower genital tract to cause
infection in the amniotic fluid and fetal membranes.
Stillbirth or neonatal death was reported ten times more often among chlamydia
positive women in a study matched with controls for age, marital status, socioeconomic
conditions, pregnancy order, and race (Martin et aL, 1982). This pregnant population had
a cervical infection rate of 6.7%. Gencay et aL reported a stillbirth at 36 weeks gestation
with chlamydia DNA positive placental tissue and histologic evidence of Chlamydia
trachomatis (1995). Thorp and colleagues reported a fetal death at 34 weeks with
histologically confirmed Chlamydia trachomatis pneumonia on autopsy (1989). Fetal loss
perhaps may be more accurately estimated from animal models. Mice models suggest
19.2% intrauterine fetal demise among those chlamydia positive (Oshiro, 1994).
Postpartum endometritis will follow approximately one-third of cases of cervical
infection during pregnancy with development of symptoms at 48 hours after delivery
(Schachter, 1999). As reported by Watts and Branham (1999), Wager and fellow
researchers in 1980 found 22% of pregnant women with cervical infection during
pregnancy developed late postpartum endometritis (1999). Paavonen et aL (1985)
suggested nonpregnancy related chlamydial endometritis is characterized by plasma cell


63
the acquisition of HTV infection during and after pregnancy with adjusted odds ratios of
1.5 to 3.7 (HMer, 1999).
Nair and others (1993) reported that HTV vertical transmission was increased with
the presence of clinical chorioaminionitis, any sexually transmitted infection during
pregnancy, and associated with LBW (p < .05). Those infants bom before 35 weeks were
significantly smaller than infants non-infected with HIV.


73
were changed to reduce the restriction on the data entry process. This change resulted in
higher rates of query flags on many variables.
The primary use of the information collected on the prenatal screening instrument
is to calculate a risk score and provide the clinician with a platform to seek consent from
the woman to assess her need for targeted services. As with other screening instruments,
the intent is a rapid reliable assessment of an at-risk status. The data entry process was not
envisioned or funded to support a standard consistent with research protocols. During the
data entry process verification of the data fields is restricted to four fields: name, social
security number, score, and date of the screening event (J. Ballard, personal
communication, June 30, 1999). However the Healthy Start coalitions are charged with
the responsibility to designate an agency that will provide training to providers on correct
use of the form, model successful solicitation of the screening process, and identify
patterns of positive risk within the community in order to target resources. Additionally,
the county health departments are charged with the responsibility to monitor the screening
instruments for completeness and coordinate the collection of missing data on queried
forms returned from the Office of Vital Statistics. This data set provided key variables for
the final study database, as are presented in Appendix A.
Maternal and infant laboratory test report database. The maternal and infant
laboratory test report database is the fourth source from which study files were extracted.
The laboratory Gen-Probe PACE2C test report data set was extracted from an existing
system database housed in the Department of Health, Bureau of Laboratories,
Jacksonville, Florida. This system was developed to support reporting compliance with
state and federal laws and regulations regarding biological specimens submitted for


229
((GWEEKS ge 38 and GWEEKS le 40) and (PREV1S ge 1 and PREVIS le 12)) or
((GWEEKS ge 41 and GWEEKS le 42) and (PREVIS ge 1 and PREVIS le 13))))
GINDEX=1.
if (((PREV1S=0)) or
(TRIMESTE=0) and (PREVIS=99)) GINDEX=1.
if ((PREV1S=99) and (TRIMESTE=0)) or
((TRIMESTE=3) and (GWEEKS ge 1 and GWEEKS le 24)) or
((TRIMESTER) and (GWEEKS ge 1 and GWEEKS le 11)) or
((GWEEKS=0) and (PREVISTO)) or
((TRIMESTE=99) and (PREVISTO)) or
((TRIMESTE=0) and (PREVIS=0)) GINDEX=1.
missing values GINDEX (-1).
execute.
FORMATS GINDEX (F8).
VARIABLE LABELS GINDEX "PNC indices".
VALUE LABELS GINDEX
.000000000000000 "adequate access to PNC"
1.00000000000000 "inadequate access to PNC".
FREQUENCIES
VARIABLES^ GINDEX
/ORDER ANALYSIS.
To create a LBWgestational indicator for crosstabs.
compute LBWGGind=0.
if (BWG eq 1 and gweeks ge 37) LBWGGind=l.
if (BWG eq 1 and gweeks le 36) LBWGGind=2.
if (BWG eq 2 and gweeks le 36) LBWGGind=2.
missing values LBWGGest (-1).
FORMATS LBWGGind (F8).
VARIABLE LABELS LBWGGind "Ibw group and gest age indicator".
VALUE LABELS LBWGGind
.000000000000000 "NBW >2500 > 37 weeks"
1.00000000000000 "TLBW >1500 <2499 >37 weeks"
2.00000000000000 "PTLBW >500 < 2499 <36 weeks"
To create a method of delivery.
compute MODindic=0.
if (MODI eq 3 or MODI eq 4) MODindic=l.
missing values MODindic (-1).
FORMATS MODindic (F8).
VARIABLE LABELS MODindic "C-section indicator".
VALUE LABELS MODindic
.000000000000000 "vaginal delivery"
1.00000000000000 "C-section".


11
Widespread screening activities among different populations and clinic settings
have demonstrated rates of infection from 3% to 25%. The positive rates in 1997 among
women 15-24 years of age, screened in family planning clinics nationally ranged from less
than 4% to greater than 11% (CDC, 1997b). A national population based survey of 1,144
participants aged 12 to 39 years, of whom 54% were female, demonstrated a 10%
chlamydial infection from urine specimens (Mertz et al, 1998). The specimens were
collected from persons not seeking medical care and contacted in their households as part
of the study to estimate the prevalence of various diseases and conditions in a non-
institutionalized United States population. Brodine et aL (1998) using ligase chain reaction
(LCR) urine technology reported positive rates of 2.7% among female naval personnel
assigned to an anchored ship, compared to 6.9% among those living on the naval base
located on shore. The average ages for these two groups were 25 and 27 years
respectively. Rates drop off significantly in age groups over 24 years, while serologic
evidence rises to about 50% of the population by age 30 years (Stamm. 1988)
Screening for chlamydia conducted in adolescents demonstrates the highest
positivity in the younger ages. Burstein et aL (1998) reported 24.1 % among adolescents
on initial visit and 13.9% on repeat visits. The investigators prospectively examined 3,202
sexually active females, following them for 33 months. Both urine and cervical specimens
were tested by PCR. Rates in female military recruits were also high. Gaydos et aL (1998)
using urine LCR reported chlamydial infection was 9.2% to 12.2% among 17-year-old
recruits, with rates higher for those from five of the southeastern states, Florida not
included. Screening conducted using EIA among U.S. Job Corps females aged 16-24
years during 1990-1994, shows 14.5% for Florida applicants (Shakarishvilli, 1995).


106
1. Development of Relational Database
1 1
(Tables 3-4)
2. Definition of Variables
¡c: -
(Table 5)
Model 1
All 21 variables
(race indicator),
LBW, TLBW,
and PTLBW
i mmsl
Model 2
20 variables (no
race indicator),
LBW, TLBW, and
PTLBW
5T
Model 3
20 variables
(white race),
LBW, TLBW, and
PTLBW
Model 4
20 variables
(black race),
LBW, TLBW,
and PTLBW
5. Second Analysis
(Tables 14-17)
6. Second Logistic Regression
Control for Inadequate Weight Gain
Model 5
Model 6
Inadequate weight gain
Adequate weight gain,
LBW, TLBW, and PTLBW
LBW, TLBW, and PTLBW
7. Third Analysis
(Tables 18-19)
Figure 4. Primary Steps in Research Analysis


211
Yu, S. M., & Nagey. (1992). Validity of self-reported pregravid weight. Annals of
Epidemiology, 2(51. 715-721.


102
was made on the laboratory file, where Vital Statistics system codes were used in place of
the county health department codes that should have been used in that database system.
Another example is exemplified by the activities related to matching the congenital
syphilis case records. All congenital syphilis case records were for infants bom in Florida
during 1996. A birth record should have been linked to each one. However, not all cases
were successfully linked. Many of the linked cases required extensive desk audits to
identify the discrepant spelling of names, transposing of first and middle names, etc. In
some cases reference to the original case worksheet was required. While the congenital
syphilis event was not integral to the original research question, the study findings clearly
suggest that the total burden of sexually transmitted diseases are a significant factor in the
increased risk of low birth weight among this population. Therefore a higher match rate
for these files was desirable.
Data quality was at times affected by computer system design flaws. This was
sometimes only detected in the analysis stage. For example, the Healthy Start prenatal
screen databases often do not have build-in restrictions to limit the valid entries in many
fields. As a result, many fields have a certain percentage of aberrant responses that
required tedious gleaning of the field and decisions on how to handle these and missing
replies at each stage of analysis.


196
Kacena, K, A., Quirni, S. A., Hartman, S. C., Quinn, T. C, & Gaydos, C. A. (1998).
Pooling urine samples for ligase chain reaction screening for genital Chlamydia
trachomatis infection in asymptomatic women. Journal of Clinical Microbiology.
36(12), 3624-3628.
Kacena, K, A., Quinn, S. A., Howell, R., Madico, G. E., Quinn, T. C., & Gaydos, C. A
(1998). Pooling mine samples for ligase chain reaction screening for genital
Chlamydia trachomatis infection in asymptomatic women. Journal of Clinical
Microbiology. 36(21. 481-485.
Keith, L. G., Papiemik, E., Keith, D. M., & Luke, B. (1995). Editors. Multiple pregnancy
- Epidemiology, gestation, and perinatal outcome. New York, London: The
Parthenon Publishing Group.
Kellog, J. A, Seiple, J. W., Murray, C. L., & Levisky, J. S. (1990). Effect of endocervical
specimen quality on detection of Chlamydia trachomatis and on the incidence of
false-positive results with the chlamydiazyme method. Journal of Clinical
Microbiology. 28(6). 1108-1113.
Kessler, H H, Pierer, K., Stuenzner, D., Auer-Grumbach, P., Haller, E-M., & Marth, E.
(1994). Rapid detection of Chlamydia trachomatis in conjunctival, pharyngeal,
and urethral specimens with a new polymerase chain reaction assay. Sexually
Transmitted Diseases. 21(4!. 191-195.
Ketterlinus, R. D., Henderson, S. H., & Lamb, M. E. (1990). Maternal age,
sociodemographics, prenatal health and behavior: Influences on neonatal risk
status. Journal Adolescent Health Care. 11. 423-431.
Klaucke, D. N., Buehler, J. W., Thacker, S. B., Parrish, R. G., Trowbridge, F. L.,
Berkelman, R. L., & the Surveillance Coordination Group. Guidelines for
evaluating surveillance systems Available: www: http:// cdc.gov/mmwr/preview/.
Klebanoflf, M. A., Mednick, B. R_, Schulsinger, C., Secher, N. J., & Shiono, P. H. (1998).
Fathers effect on infant birth weight. American Journal of Obstetrics and
Gynecology, 178151. 1022-1026.
Kluytmans, J. A. J. W., Niesters, H. G. M., Mouton, J. W., Quint, W. G. V., Ijpelaar, J. A.
J., Van Rijsoort-Vos, J. H, Habbema, L., Stolz, E., Michael, M. F., &
Wagenvoort, J. H. T. (1991). Performance of a nonisotopic DNA probe for
detection of Chlamydia trachomatis in urogenital specimens. Journal of Clinical
Microbiology. 29/121. 2685-2689.
Kogan, M. D., Alexander, G. R., Kotelchuck, M., &Nagey, D.A. (1994). Relation of the
content of prenatal care to the risk of low birth weight: Maternal reports of health


92
whether die redded within or without the limits of her town or city. The county and city
limits fields were from the birth record. The population parameters were assigned from the
Florida 1999 Population Estimates provided by the Division of Economic Demographic
Research, Joint Legislative Management Committee, 1998 Mid-Year Estimates.
Prenatal care indices were assigned to each record of 1 or O. This proved to be
one of the more challenging variables to develop! The literature abounds with studies that
report measures of adequacy of care and their association with birth outcomes. Most were
developed for routine, low risk prenatal care and do not account for high risk pregnancies
where more frequent visits would be recommended during the course of pregnancy
(Stringer, 1998). While all published indices are used to measure a defined adequacy of
prenatal care they actually count number of visits, and trimester of entry into care. None
really achieve any assessment of the quality of care, the content of care, or the presence,
absence or scope of particular care components. Several measures endeavor to adjust the
expected number of visits to trimester of initiation, parity, and gestational age at birth. The
GINDEX revised ACOG index of inadequate prenatal care utilization criteria and missing
care was utilized to create a variable of inadequate prenatal care indices. (Alexander &
Kotelchuck, 1996; Alexander, Tompkins, Petersen., & Wesis, 1991). These indices were
selected since syntax was available for reference, and because it most closely resembles the
county health department standards for prenatal care initiation in the first trimester and the
number of recommended visits. See Appendix B for the syntax and more detail.
Prior poor pregnancy outcome was computed from fields contained in the birth
record (previous infant 4000+ grams, previous pre-term or small-for-gestational-age
infant) and from the Healthy Start prenatal screen file (prior pre-term, prior LBW). A risk


205
Ruggiero, L., & Groot, M. (1998). Smoking patterns of low-income ethnoculturally
diverse pregnant women: Are we casting a net wide enough? Addictive Behaviors.
23(4), 549-554.
Ryan, G. M., Abdella, T. N., McNeeley, S. G., Baselski, V. S., & Drummond, D. E.
(1990). Chlamydia trachomatis infection in pregnancy and effect of treatment on
outcome. American Journal of Obstetrics and Gynecology, 16201. 34-39.
Schachter, J. (1990). Biology of Chlamydia trachomatis. In K. K. Holmes, P. A. Mardh,
P. F. Sparling & P. J. Wiesner, (Eds.), Sexually transmitted diseases (pp. 167-
180). Hew York, NY: McGraw-Hill, Inc.
Schachter, J. (1995). Chlamydia. In E. H Lennette, D. A. Lennette, & E. T. Lennette,
(Eds.), Diagnostic procedures for viral, rickettsial and chlamydial infections (pp.
231-244). Washington, DC: American Public Health Association.
Schachter, J. (1999a). Biology of Chlamydia trachomatis. In K.K Holmes, P. F. Sparling,
P. A. Mardh, S. M. Lemon, W. E. Stamm, P. Piot & J. M. Wasseiheit, (Eds.),
Sexually transmitted diseases (3rd ed., pp. 391-405). New York, NY: McGraw-
Hill, Inc.
Schachter, J. (1999b). Infection and disease epidemiology. In R. S. Stephens, (Ed.),
Chlamydia: Intracellular biology, pathogenesis, and immunity (pp. 139-170).
Washington, DC: American Society for Microbiology.
Schachter, J., Grossman, M., Sweet, R. L., Holt, J., Jordan, C., & Bishop, E. (1986).
Prospective study of perinatal transmission of Chlamydia trachomatis. Journal of
the American Medical Association, 255(24). 3374-3377.
Schachter, J., Sweet, R. L., Grossman, M., Landers, D., Robbie, M., & Bishop, E. (1986)
Experience with the routine use of erythromycin for chlamydial infections in
pregnancy. New England Journal of Medicine. 314(5). 3374-3377.
Schieve, L. A., Cogswell, M. E., & Scanlon, K S. (1999). Maternal weight gain and
preterm delivery: Differential effects by body mass index. Epidemiology. 10(21.
141-147.
Schmitt, K (1996a). [1995 Prevalence estimate of chlamydial and gonorrhea infections in
Florida]. Unpublished raw data, Florida Department of Health, Tallahassee.
Schmitt, K. (1996b). [1996 Positivity rates for chlamydial and gonorrhea infections among
counties participating in the Florida infertility prevention project]. Unpublished raw
data, Florida Department of Health, Tallahassee.


86
last menstrual period date could be entered onto the birth or fetal death record based on
either information contained in the prenatal records collected long before the birth and
available at the time of the delivery, or on maternal recall However calculated gestation is
not as likely to be influenced by the birth outcome.
All live births and fetal death records without a recorded last menstrual period
(LMP) or a LMP month with a value of more than 12 or less than 1, from which to
compute the gestation,were assigned to the missing values category (12,557/6.4%).
Additionally, following calculation, any record with a gestational age less than 20 weeks
(79/0.2%) or more than 42 weeks (6,373/3.3%) was also assigned to the missing values
in the computations.
Two other methods have been employed elsewhere but not in this study to address
inconsistency in birth weight to gestation ratios. One method is a comparison of the
calculated to the estimated with selection of the one most consistent with the reported
birth weight. Another method has been to redistribute all records with inconsistent outlier
values to the distribution observed in those with valid parameters.
Independent indicator variables: (Please refer to Table 3.).
Age at the time of delivery was calculated from maternal date of birth and
incrementally grouped into < 15, 15-19, 20-24, 25-34, 35-39, 40-44, and > 45 years for
the initial analysis and calculation of crude odds ratios. For the logistic regression
modeling, the maternal age variable was assigned a value of1 for women younger than
18 and women 40 years or older, and a value ofO for age 19 to 39 (Gjerdingen, 1992;
Buescher, Taylor, Davis., & Bowling, 1993; Ketterlinus, Henderson, & Lamb, 1990;
Rosenfeld, 1990).


37
investigated, the actual mechanism of pathogenesis in humans has yet to be proven. There
is, however, mounting evidence that the bacteria can and do invade epithelial host cells at
different levels of the female reproductive tract, and at different times during the
reproductive cycle, e.g., pregnant and non-pregnant states. The role of persistent
chlamydial infection is also unclear in the process of pathogenesis. Beatty and colleagues
(1994) reviewed the conflicting evidence for persistent infection and concluded that
further work following infected culture negative persons should be conducted. Byme
(1996) also discussed the work to date on persistence and suggested that certain features
associated with in vivo growth of chlamydiae would further support some form of
persistent infection. These include the presence of abnormally large intracellular forms of
the organism, chlamydial nucleic acid in absence of cultivable forms, immunologic
evidence of heightened reactivity to stress response proteins, and continuous presence of
chlamydial antigen. Bragina, Gomberg and Orlova (1998) reported morphological changes
in chlamydial bodies in persons with reported latent chlamydial infection. Others have
recently reported in vitro persistence of chlamydial antigens, and chlamydial particles while
studying antibiotic efficacy (Dreses-Werringloer, Jurgens, Zeidler, & Kohler, 1998).
Neeper, Patton, and Kuo (1990) provide cinematographic in vitro observation of
Chlamydia trachomatis growth cycles in primary cultures of human amniotic cells. Of
significant note, given the difficulty of culturing this bacterium, were the sustained cycles
of infection that occurred, until all amnion epithelial cells in the monolayer had been
infected and destroyed. While in this study the amniotic epithelial cells were isolated from
the in vivo placental structure, the chlamydiae were capable of damaging the placental


Abstract of Dissertation Presented to the Graduate School
of the University of Florida in Partial Fulfillment of the
Requirements for the Degree of Doctor of Philosophy
CHLAMYDIAL INFECTION IN PREGNANCY:
AN ASSOCIATION WITH LOW BIRTH WEIGHT
By
Karla Schmitt
December 1999
Chair: Sharleen H. Simpson
Major Department: College of Nursing
The purpose of this study was to determine whether infection with Chlamydia
trachomatis during pregnancy was associated with low birth weight. A retrospective
population based study was conducted on a sample of 14,002 records. The records were
extracted from a large relational database constructed from birth and fetal death records,
prenatal risk screening records, sexually transmitted case reports and laboratory test
reports. Extensive independent indicator variables were created to control for potential
interaction between known risk factors and chlamydial infection. Descriptive, bi-variate
and logistic regression analyses were conducted.
Statistically significant associations were observed among women with inadequate
weight gain, chlamydia infection and low birth weight at 95% confidence interval (OR
1.98, p <0.02). A stronger association was observed with pre-term low birth weight (OR
x


136
Again, surprisingly, women in this set also were 32% less likely to experience a
PTLBW infant if the mother was not a high school graduate. The second set was run
without any identification of race entered among the independent variables. Table 15
presents the data at the final step in each logistic model for this set.
Logistic model two: All CHD without any race indicator low birth weight. As in
the first set of models, the first sub-sample examined women identified as having a low
birth weight infant. Due to missing data on 161 of the 14,002 women in the study sample,
13,841 cases were included in this analysis and terminated after the 11th step. (Please refer
to Table 15.)
The chlamydial infection indicator was eliminated at the 2nd step due to low
significance. The gonorrheal infection indicator was eliminated at the 5th step (OR 1.41, p-
value .4366, 95% Cl .5907, 3.3848). Pregnant women in the low birth weight non-race
sub-sample exhibited a substantially higher risk for low birth weight associated with the
following independent variables:
OR 2.63, mother had inadequate weight gain
OR 1.88, use of alcohol at any time during pregnancy
OR 1.88, a history of a prior poor pregnancy outcome
OR 1.70, a history of any sexually transmitted infections
OR 1.53, mother weighed less than 5.5 pounds when she was bom
OR 1.48, identified as having smoked at any time during pregnancy
OR 1.46, mother not married


142
The gonorrheal infection and any sexually transmitted infection indicators were
eliminated at the 4* and final 5th steps due to low significance. The chlamydial infection
indicator was retained until the final step (OR 1.48, p-value .1252, 95% Cl .6859,
2.4590). Pregnant women in this sub-sample exhibited a substantially higher risk for
PTLBW associated with the following independent variables:
OR 3.75, mother had inadequate weight gain
OR 1.73, a history of medical conditions during pregnancy
OR 1.67, use any form of tobacco in the two months prior to HS Screen
OR 1.44, mother bom in another country
OR 1.43, a history of a prior poor pregnancy outcome
OR 1.39, mother not married
Logistic model four: Women of black race only low birth weight. The final set
included only women of black race. Due to missing data on 68 of the 4,217 black women
in the study sample, 4,149 cases were included in this analysis and terminated after the 14th
step. (Please refer to Table 17.)
The gonorrheal and chlamydial infection indicators were eliminated at the 5th and
7th steps due to low significance. The independent variables found strongly associated with
an increased risk of low birth weight were fewer and two were identified as protective:
OR 2.67, mother had inadequate weight gain
OR 2.67, a history of a prior poor pregnancy outcome
OR 1.93, identified as having smoked at any time during pregnancy
OR 1.78, a history of any sexually transmitted infections
OR 1.58, mother weighed less than 5.5 pounds when die was bom


175
reproductive health care, might be an appropriate avenue to routinely review the suitability
of data systems to support analyses from linked and relational databases.
Schools of nursing should strengthen course work on data management and
information in order to prepare advanced practice nurses better for future involvement in
the decision analysis process. Future advanced practice muses will need to acquire more
sophisticated skills in the area of data management at the clinical level as well as
interpretation of clinical evidence and epidemiological reports. This will be integral in
order for nurses to more fully participate in collaborative work group activities aimed at
the development of new data systems that will support analysis of evidence-based clinical
musing and medicine.
The sexually transmitted disease case morbidity system merits closer scrutiny to
evaluate the capacity of the system to support future examination of the reproductive
outcomes sustained by women infected with STDs. To effectively capture the full
reproductive history of women in the childbearing years, additional fields should be
developed within the case morbidity system. A designated field(s) is only a part of the
answer. A field must be accurately completed to be useful for future analysis that will
provide insight into the relationship(s) between chlamydia, and other sexually transmitted
infections and pregnancy outcomes. Another change to the surveillance system that might
assist regional area STD Managers, would be an automatically generated report that
would alert surveillance staff regarding the percentage of cases with unacceptable test to
treatment intervals. Such reports may heighten awareness among county health
department staff regarding the need to educate select community providers on appropriate
treatment intervals and stimulate identification of the barriers that contribute to the


122
Among those women over 18 years of age who did not complete high school, 71.7% were
of white race/ethnicity.
Significantly more women were unmarried in the study sample (60.6%) as compared to
35.2% of those in the larger group. An interesting finding was the different distribution for
short birth interval. However, this would be consistent with the observed older age
distribution of the relational database, marital status and more opportunity for conception.
More than two and a half times as many women in the study ample stated their pregnancy
was mistimed. Even with the removal of Cesarean section deliveries it was interesting to
observe that the history of an event of a prior poor pregnancy outcome was more than
twice that of the larger group. The most marked difference between the two groups was
that nearly all women in the study sample identified something in their lives that would
suggest that their lives were stressful The percent of women residing in rural areas was
higher for the study sample, 38.2% as compared to 34.9%.
Alcohol use reflects the frequency presented in Table 5 as do the remaining other
independent variables for the two groups e.g., tobacco use, black race, mother foreign
bom, chlamydia and gonorrhea positive, medical history, and mother low birth weight
herself
Bivariate Analysis
Each of the dependent variables was examined for potential associations with all of
the independent variables at the 95% confidence level Odds ratios and p-vahies were
calculated for the independent variables to predict the probability of the occurrence of
LBW, TLBW or PTLBW in association with each designated risk or measure. The


223
To create a stress indicator variable.
(this combined admission of stress, with violence, hunger, appointment
problems/transportation, multiple moves)
compute stresind=0.
if (NO COVER =T) stresind=l.
if (APPOINTM=l) stresind=l.
if (MOVED =1) stresind=l.
if (UNSAFE =1) stresind=l.
if (HUNGRY =1) stresind=l.
if (HURTYOU =1) stresind=l.
if (STRESS =2) stresind=l.
if (STRESS =3) stresmd=l.
missing values stresind (-1).
FORMATS stresind (F8).
VARIABLE LABELS stresind "stress full life indicator".
VALUE LABELS stresind
.000000000000000 "low/no stress"
1.00000000000000 "high stress.
FREQUENCIES
VARIABLES=stresind
/ORDER ANALYSIS.
To create a mistimed pregnancy' indicator variable.
(this combined earlier, later, not at all)
compute mistimm=0.
if (PREFERPG =1) mistimm=l.
if (PREFERPG=2) mistimin=l.
if (PREFERPG =3) mistimin=l.
missing values mistimin (-1).
FORMATS mistimin (F8).
VARIABLE LABELS mistimin "mistimed pregnancy indicator".
VALUE LABELS misrimm
.000000000000000 "pregnancy timing ok"
1.00000000000000 "mistimed pregnancy".
To create a prior poor outcome pregnancy indicator variable.
(this combined prior low birth weight, prior preterm, prior miscarriage, prior stillbirth)
compute poorouti=0.
if(POOROUTC eq 1) poorouti=T.
if (OB_HX_PR ge T) poorouti=l.
if (OB_HX_LB ge T) poorouti=l.
if (MHF1 eq 13) poorouti=l.
if (MHF2 eq 13) poorouti=l.
if(MHF3 eq 13) poorouti=l.


Copyright 1999
by
Karla Schmitt


29
Order: Chlamydiales
Family: Chlamydiaceae
Genus: Chlamydiales
Species:
Psittaci: affects cats, birds,
humans, and hoofed animals
Includes the following human
serovars: D85711, D85712,
Cal-10, and human
meningopneumonititis.
Pecorum: affects cattle,
sheep and koala bears.
Pneumoniae, affects equmes and
humans. Includes N16 the only
equine serovar and the following
human serovars; PI-Parola,
S562B, 10L207, TW183.
Trachoma
I
A, B, Ba, C
Trachomatis: affects humans and other
mammals Includes the following
serovars that effect humans unless
indicated in parenthesis.
J
Lymphogranuloma
Venereum
I
Ll,L2,L2a,L3
MoPn (mouse),
S45, R22 (pig),
SFPD (hamster)
Urogenital
I
B, D, Da, D\
Dv,E,F,G,H,I,
J, Ja, K
Content adapted from Tanner, Harris, & Pace, 1999; Schachter, 1999a; Stamm, 1999;
Morre et aL, 1998.
Figure 2. Chlamydiales Tree.


179
Significant associations were identified in this study that utilized a chlamydia test
with less than ideal sensitivity. This would suggest that policy makers should consider
identification of funding to support distribution of more sensitive testing methodologies
through county health department clinics. The cost to the community from low birth
weight is significant; there are both financial and health related costs for the individual
family and the affected infant.
The findings from this study should be disseminated to policy makers associated
with regional prenatal care coalitions, community nurse practitioners, physicians and
physician assistants, to county health department staff and to the general public.
Additionally, the information contained in this study should provide valuable stimulus to
foster other research projects among current students of advanced practice musing.
Suggested future research topics follow below.
Implications for Future Research
Numerous interesting future research avenues are suggested by the findings in this
study. First, stratification by socio-economic status through the use of geocoding, census
data and fee eligibility determination data linked to the study database, should be the next
analysis. Closer examination of treatment information contained in this database, as well as
enhancement with treatment records for women infected with chlamydia would provide
opportunity to clarify some questions raised during the analysis. Linkage of pending
Medicaid files to the study database should be completed in order to support more
comprehensive analyses with the existing database. And sometime in the future, another


176
delayed time frames. Automatically generated flyers on treatment guidelines (or updates)
could be mailed to nurse practitioners and physicians who did not use treatment options
recommended by national guidelines for sexually transmitted infections. If these and other
reports are shared directly with nurse practioners and physicians, disease investigators will
have additional opportunities to offer their services for partner elicitation and notification
to the clinicians. Similarly, other system changes could alert county health department staff
when any reported STD case involves a woman who is pregnant. This may assist to
reduce re-infection of the pregnant woman through increased awareness among county
health department staff regarding the need to more rapidly locate any untreated partner(s)
and document treatment.
Evidence in this study suggested a much wider involvement of syphilis in adverse
pregnancy outcomes. None of the women identified with low birth weight, who were also
infected with late syphilis, were identified as pregnant in the case morbidity system
However, all except one of the women, who sustained a fetal death while infected with
syphilis, was identified within the case morbidity system This variability of reproductive
health related data suggests that an independent evaluation of the quality of the case
morbidity information and subsequent documentation on field and medical records should
be considered. Quality assurance audits on the entry of case data entry into the STD*MIS
should be regularly scheduled, and conducted at all levels of data entry, to better ascertain
potential discrepancies in demographic data.
The fetal death certificate does not presently provide a field for reporting of
syphilis diagnosis in the mother during pregnancy. Stillbirth is highly associated with
syphilis infection during early pregnancy and continues at a reduced rate throughout the


186
CDC. (1995). Sexually transmitted disease surveillance 1994. Atlanta: Centers for Disease
Control and Prevention, Division of STD Prevention.
CDC. (1996a). Summary of notifiable diseases, united states, 1995. Morbidity and
Mortality Weekly Review. 451411. 883-884.
CDC. (1996b). Sexually transmitted disease surveillance 1995. Atlanta: Centers for
Disease Control and Prevention, Division of STD Prevention.
CDC. (1997a). Case definitions for infectious conditions under public health surveillance.
Atlanta: Centers for Disease Control and Prevention, Division of STD Prevention.
CDC. (1997b). Sexually transmitted disease surveillance 1996. Atlanta: Centers for
Disease Control and Prevention, Division of STD Prevention.
CDC. (1997c). Sexually transmitted disease surveillance 1996. Atlanta: Centers for
Disease Control and Prevention, Division of STD Prevention.
CDC. (1998a). Sexually transmitted disease surveillance 1997. Atlanta: Centers for
Disease Control and Prevention, Division of STD Prevention.
CDC. (1998b). 1998 Guidelines for treatment of sexually transmitted diseases. Morbidity
and Mortality Weekly Review. 47(RR-1).
CDC. (1999a). Sexually transmitted disease surveillance 1998. Atlanta: Centers for
Disease Control and Prevention, Division of STD Prevention.
CDC. (1999b). Pregnancy nutrition surveillance. 1996 executive summary Atlanta, GA:
Centers for Disease Control and Prevention, Division of Nutrition and Physical
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CDC. (1999c). Prevalence of selected maternal and infant characteristics, pregnancy risk
assessment monitoring system (PRAMS), 1997. Morbidity and Mortality Weekly
Review. 481SS-5).
Cehim, C. L., Wilch, E., Fennell, C., & Stamm, W. E. (1994). The pratitioners handbook
for the management of STDs (2nd ed). Seattle, WA: University of Washington.
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diseases (3rd ed., pp. 1281-1294). New York, NY: McGraw-Hill, Inc.


135
OR 1.79, a history of any sexually transmitted infections
OR 1.48, age under 18 or over 40 years
OR 1.43, use drugs or alcohol in the two months prior to HS Screen
OR 1.31, indices of inadequate prenatal care visits
Counter intuitively, women in this set also were 27% less likely to experience a
TLBW infant if the interval from their previous pregnancy was less than nine months.
Logistic Model One: All CHD with race indicator PTLBW. The third sub-sample
model in this set examined women identified as having a pre-term low birth weight infant.
Due to missing data on 493 of the 14,002 women in the study sample, 13,509 cases were
included in this analysis and terminated after the 13th step. (Please refer to Table 14.)
The gonorrheal infection and any sexually transmitted infection indicators were
eliminated at the 4th and final 5th steps due to low significance. The chlamydial infection
indicator was retained until the final step (OR 1.48, p-vahre 1252, 95% Cl .6859,
2.4590). Pregnant women in this sub-sample exhibited a substantially higher risk for
PTLBW associated with the following independent variables:
OR 3.31, mother had inadequate weight gain
OR 2.03, mother was of black race
OR 1.91, a history of a prior poor pregnancy outcome
OR 1.45, use of any form of tobacco in the two months prior to HS Screen
OR 1.44, a history of medical conditions dining pregnancy
OR 1.79, mother weighed less than 5.5 pounds when she was bom
OR 1.26, indices of inadequate prenatal care visits
OR 1.24, mother not married mother not married


124
Table 10. Unadjusted Odds Ratios for Low Birth Weight Based on Bi-variate Analysis of
Independent Variables in the Study Sample.
Variable
OR
95% Cl
p value
1.
Age < 18, >40
1.39
1.27, 1.54
0.0004
2.
Alcohol use from birth record
0.18
0.11,0.27
0.0000
3.
Alcohol use from Healthy Start screen
1.35
1.23, 1.48
0.0016
4.
Birth interval short
1.11
1.01, 1.21
0.2573
5.
Chlamydia positive
1.88
1.28, 2.74
0.0012
6.
High school no
0.83
0.72, 0.97
0.0173
7.
Gonorrhea positive
2.96
2.01, 4.36
0.0050
8.
Inadequate PNC indices
1.42
1.32, 1.53
0.0000
9.
Inadequate weight gain
3.12
2.90, 3.36
0.0000
10.
Married not
1.49
1.38, 1.61
0.0000
11.
Medical history
1.35
1.21, 1.51
0.0058
12. Mistimed pregnancy
1.11
1.04, 1.20
0.1383
13.
Mom foreign bom
0.76
0.64, 0.91
0.0020
14.
Mom LBW
1.66
1.50, 1.84
0.0000
15.
Prior poor pregnancy outcome
1.95
1.80, 2.11
0.0000
16.
Race of mother black
1.98
1.84,2.13
0.0000
17.
Rural residence
0.91
0.79, 1.05
0.2103
18.
Smoking from birth record
1.57
1.45, 1.70
0.0000
19.
Smoking from Healthy Start
1.28
1.18, 1.38
0.0012
20.
STDs, past or current
2.04
1.71, 2.43
0.0001
21.
Stressful life
0.89
0.74, 1.08
0.2348
A positive chlamydia test was found significantly associated with low birth weight
(OR 1.88), term low birth weight (OR 1.87), and pre-term low birth weight (OR 1.86). In
the pilot study on which this study was modeled, chlamydial infection was also
significantly associated with low birth weight (OR 2.40), term low birth weight (OR 2.40),
and pre-term low birth weight (OR 2.19) at the bivariate level of analysis. Two other STD
related risks were examined, infection with gonorrhea and a pooled variable that included
syphilis, infant infection, and maternal chlamydia and gonorrhea. The variable indicating


138
Logistic model two: All CHD without any race indicator TLBW. The second
sub-sample model in this set examined women identified as having a low birth weight
infant. Due to missing data on 613 of the 14,002 women in the study sample, 13,389 cases
were included in this analysis and terminated after the 10th step. (Please refer to Table
15.).
The chlamydial infection indicator was eliminated at the 3rd step due to low
significance. The gonorrheal infection indicator was retained until the 9th step (OR 2.36, p-
vahie .1367, 95% Cl .7616, 7.3117). Pregnant women in this sub-sample exhibited a
substantially higher risk for TLBW associated with the following independent variables:
OR 2.58, mother had inadequate weight gain
OR 2.23, use of alcohol at any time during pregnancy
OR 2.01, a history of any sexually transmitted infections
OR 1.93, a history of a prior poor pregnancy outcome
OR 1.91, mother weighed less than 5.5 pounds when she was bom
OR 1.83, identified as having smoked at any time during pregnancy
OR 1.50, age underl8 or over 40 years
OR 1.38, use drugs or alcohol in the two months prior to HS Screen
OR 1.30, indices of inadequate prenatal care visits
OR 1.27, mother not married
As with the first model for TLBW, women in this set also were 27% less likely to
experience a TLBW infant if the interval from their previous pregnancy was less than nine
months from the their last menstrual period before this pregnancy.


155
Information regarding trimester of initiation into prenatal care was available from
the Healthy Start prenatal screen on 63% (186/295) of the women with syphilis. For these
women, all but 11.8% entered prenatal care, 48.3% in the first trimester, 29.6% in the
second, and 10.2% in the last trimester. Among the women in the study sample, the
distribution was different, with 54.3% entering in the first trimester, 37.1% in the second,
and 8.6% in the third semester. Dual infection with chlamydia and gonorrhea was present
in 8.4% of the study sample; this rate is fourteen times that observed in the statewide
prevalence estimate based on all public health laboratory chlamydia and gonorrhea test
results during 1996. It is nearly seventeen times the rate observed among the prenatal
specimens. Table 20 below summarizes the STD related finding from this study.
Table 20. Comparison of Odds Ratios in the Study Sample for Different STD Variables
and Adverse Birth Weights.
Low Birth Weight
OR
p value
Chlamydia positive, adjusted for inadequate weight gain
1.98
0.0184
STDs past or present, with all variables
1.48
0.0278
STDs past or present, without any race indicator
1.70
0.0029
STDs past or present, among women of black race
1.78
0.0046
Term Low Birth Weight
OR
p value
Gonorrhea positive, adjusted for adequate weight gain
5.11
0.0025
STDs past or present, with all variables
1.79
0.0075
STDs past or present, without any race indicator
2.01
0.0029
STDs past or present, among women of black race
2.24
0.0073
Pre Term Low Birth Weight
OR
p value
Chlamydia positive, adjusted for inadequate weight gain
2.34
0.0099
STDs past or present, without any race indicator
1.65
0.0362
STDs pat or present, among women of black race
1.72
0.0383


156
Outcome of Research Question
The research question: What associations) exist(s) between low birth weight and
Chlamydia trachomatis infection during pregnancy?
A significant association at the unadjusted level was found for chlamydia
infection in pregnancy for low birth weight and for pre-term low birth weight.
Women with Chlamydia trachomatis during pregnancy would have more than
an 80% increased probability of low birth weight and pre-term low birth weight
based on these findings alone.
After adjusting for other independent risk factors and inadequate weight gain, a
significant association was found for chlamydia infection in pregnancy. The
association at 95% confidence interval was OR 1.99, p < 0.02 for low birth
weight, and OR 2.34, p < 0.01 for pre-term low birth weight in this study. In
contrast to the pilot study on which this study was modeled, the strongest
association was found in term low birth weight infants, OR 2.50, p < 0.0000.
The chlamydia positivity observed in this study sample derived from women
who received their care from county health depatments is less than one half
that observed in the prenatal county health department population from which
the laboratory data set was constructed and subsequently linked to the 1996
birth and fetal death records.


51
placental weight was compared to birth weight, and the average national maternal food
ration during the war years was used to estimate under nutrition. Among infants exposed
to the risk factor in the third trimester, mean birthweight decreased. No change in birth
weight was observed among infants exposed in the first trimester, but there was an
increase in placental weight and index to the birth weight. The author also references other
studies that have reported an increase in placental index in the presence of anemia and
maternal smoking. Another study that examined Women Infant and Children (WIC)
program enrollment identified a small but significant protective odds ratio for small for
gestational age the longer that a women was enrolled in the program (Ahluwalia, Hogan,
Grummer-Strawn, Colville, & Peterson, 1998).
Hickey, Cliver, Goldenberg, McNeal, and Hoffman (1997) examined risk factors
that might contribute to low prenatal weight gain. They studied non-obese low-income
women and controlled for socio-demographic lifestyle and reproductive characteristics.
Three characteristics were associated with significant odds of low prenatal weight gain
among women of black race: a mistimed or unwanted pregnancy (OR 2.0), more than one
preschool child at home (OR 2.0), and not using her own car for errands (OR 2.1).
Among women of white race only, working more than 40 hours per week was associated
with low prenatal weight gain (OR 9.1).
Many different measures have appeared in the literature to define and assess the
adequacy of prenatal care. Adequacy of care or utilization is then examined along with
other variables for its association with LBW. Overall most of these measures recommend
initiation into care during the first trimester and then some pre-set number of visits with
consideration for length of gestation (Alexander & Kotelchuck, 1996). These measures


21
cases, due to the uncommonly low reporting levels. Authors of one recent survey study
found that providers only reported 42% of gonorrhea, 56% of chlamydia and 58% of
primary and secondary syphilis diagnoses (Hammett, Kaufman, Faulkner, Hoagin, &
Battaglia, 1996). Between the years 1994 and 1997 the total number of reported
chlamydia opthalmia cases for the United States ranged from 152 to 262, while for the
same period 48 to 1,560 cases of gonorrhea opthalmia were reported (CDC, 1995, 1996b,
1997b, 1998a). These reported cases inversely reflect the level of reported gonorrhea
nationally in women of reproductive age.
Additionally, one is reminded of the inefificacy of drugs currently used for ocular
prophylaxis of chlamydia opthalmia at the time of delivery (CDC, 1998b). Drugs currently
recommended for ocular prophylaxis include 1 percent silver nitrate, 1 percent tetracycline
ointment and 0.5 percent erythromycin (Gutman, 1999; Schachter et aL, 1986). While
efficacy of these drugs is high for prevention of gonoccocal opthalmia, their efficacy for
preventing chalmydia opthalmia is unacceptable. In short, there is no gold standard at
present for efficacious and comprehensive ocular prophylaxis. Hammerschlag (1999)
summarizes the numerous studies and concludes that the information is inconclusive. He
notes that none of the drugs studied for ocular prophylaxis is reported to be universally
efficacious. He ultimately recommends that effectiv e screening and treatment during
pregnancy remains the most effective method of control.
Diagnostic and political considerations further complicate the situation. Nearly all
cases of opthalmia are diagnosed after discharge from the hospital Such cases are often
sub-acute and diagnosis requires appropriately collected specimens that contain
conjunctival cells, not exudate alone, and the use of sensitive and specific tests. Many


47
reported as indeterminate accompanied by the recommendation that the clinician obtain
a follow-up specimen for re-testing if the patient has not already been treated for infection.
Test results are calculated based on the difference between the response in relative
light units (RLU) recorded from the specimen and the mean of the negative reference
readings (Gen-Probe Incorporated, 1994a). Before testing each day, equipment is re
calibrated and cut-off ranges for RLU reading are set.
Related urogenital organisms may be present concomitantly with either chlamydia
or gonorrhea. Among these are Chlamydia psittaci, Ureplasma urealyticum, Gardenella
vaginalis, and Candida albicans. Analytical specificity of Gen-Probe indicates these
organisms do not cross-react with Chlamydia trachomatis or Neiserria gonorrheae
probes during testing (Gen-Probe Incorporated, 1994b).
Risk Factors for Low Birth Weight
Many variables have been reported in the volumes of literature on risk factors
associated with LBW. Investigators have studied the associations between birth outcomes
and malnutrition, smoking, reduced or absent social support, employment, violence, work,
stress, poverty, age and education, high and chronic stress, low-socioeconomic status,
utilization of and access to prenatal care, member of minority ethnic or racial group, drug
and alcohol use and infectious diseases. Much of this work has been focused on
identification of markers for pre-term birth or low birth weight. Less is known about the
role of psychosocial factors and the comparison of these variables for term low birth
weight and pre-term outcomes. Some key findings on a number of the potential
independent variables are summarized below.


15
(Gittens, Nichols & Apuzzio, 1994). In that same study 25% had more than one sexually
transmitted infection. Cohen and colleagues (1990) reported 5.75% prevalence using
direct antigen methods. Another group of researchers who cultured vaginal lavage
specimens after premature rupture of the membranes found 14% positive for chlamydia
(Harger et al., 1991). Nearly 22% prevalence based on culture was reported for initial
prenatal visits among urban lower socioeconomic women (Ryan, Abdella, McNeeley,
Baselski, & Drummond, 1990). Using two antigen detection systems researchers reported
that specimens collected from pregnant women had higher rates of inclusions than those
collected from nonpregnant women. However the difference was not statistically
significant (p < 0.096) in this study conducted with a population whose prevalence was
9.1% among nonpregnant women and 12% among pregnant women (Smith et aL, 1987).
The natural history of the infection in a pregnant woman is less well understood.
There are inconsistent reports and evidence of disease progression from initial chlamydial
infections. Among pregnant women infected with Chlamydia trachomatis, fetal loss has
rarely been reported, premature delivery is experienced by 10-30%, and perinatal infection
by 40-70% (Jones, 1999). There is evidence to support a progression from cervicitis with
ascent to cause intrauterine infection. Greater than 11% of infants bom to women with
cervical infection were found to have antichlamydial antibodies in their cord serum (Fejgin
et al., 1997). Harger and colleagues (1991) reported a different finding of no chlamydia
positive cultures from amniotic fluid in their study of sub clinical chorioamnionitis among
asymptomatic afebrile women in pre-term labor with intact membranes. Among patients
with premature rupture of membranes in another study, the presence of chlamydial
infection neither increased the incidence of chorioamnionitis nor decreased the latent


49
Copper and colleagues (1996) examined stress through measurement of anxiety,
self-esteem, mastery, depression, and stress. They reported that stress was associated with
PTL, SGA, and LBW after adjustment for maternal behavioral and demographic
characteristics. Among black women, this was even more significantly associated. Other
researchers identified maternal residence in public housing, poverty, and feelings of
helplessness with significant decreases in mean birth weight (Shiono et aL, 1997).
The role of maternal employment on LBW and gestation is also conflicting.
However two studies conducted with women in other countries suggest that intrauterine
growth restriction and PTL may be affected by moderate to heavy physical work effort
(Spinillo et aL, 1996; Launer, Villar, Kestler, & Onis, 1990).
Smoking during pregnancy has been found to be significantly associated with
LBW, TLBW, and PTLBW. Increased risks ranges from OR 2.1 to OR 2.8 and appear to
be dose related (Cnattingius & Haglund, 1997; Olsen, 1992; Sexton & Hebei, 1984). One
Swedish study examined data for births from 1983 to 1992 and reported a true decrease
in smoking diming pregnancy and reduction in the attributable risk for SGA infants
(Cnattingius & Haghrnd, 1997). The highest odds ratio, 2.8, was observed each year
among women smoking more than ten cigarettes per day.
Another area of study related to smoking and potential LBW is the differences
between race and ethnic groups and tobacco use. Among those women who quit smoking
sometime during their pregnancy, more women were of white race/ethnicity (12.7%)
compared to 4.3% of Hispanic race/ethnicity (Ruggiero & Groot, 1998). Among those
women identified as never having smoked the percent was inversely related 41.5% for
women of white race/ethnicity and 81.6% of Hispanic race/ethnicity. Ahijevych and


CHAPTER 3
METHODOLOGY
In this chapter the research design, protection ofhuman subjects, confidentiality,
data sources, develophnent of the relational database, methodological issues in the use of
administrative databases, definition of study variables, data analysis, limitations, and
assumptions are addressed.
Research Design
This was a retrospective epidemiological study of a population-based sample of
pregnant women and adolescents who initiated prenatal care through county health
departments. A relational study database was constructed from linked data files. The files
were extracted from numerous administrative databases. The records of infants bom
during 1996 and their mothers were linked to laboratory tests, disease reports, and
prenatal screening information through the use of probabilistic matching algorithms.
Descriptive analysis of all files and the extracted study file was conducted. Logistic
regression analysis was conducted to further explore the association between infection
with Chlamydia trachomatis and low birth weight. The data sources, process of matching
records, and analysis that was conducted are described in detail below.
64


CHAPTER 1
INTRODUCTION
Problem Statement
Chlamydia trachomatis is the most commonly reported sexually transmissible
disease in the United States since 1995. The national rates for Chlamydia trachomatis are
particularly high among women, ranging from fewer than 150 to more than 300 cases per
100,000 female population during recent years (CDC, 1996a, 1997c, 1998a). Among
populations of childbearing women, case report rates vary by age, race, socioeconomic
status, service setting, and area of the country. Young women are most at risk for
infection, with national case report rates during 1997 as high as 2,044 per 100,000 among
females age 15-19 years and higher in Florida at 2,208 per 100,000 among females age
15-19 years (CDC, 1998a; Florida Department of Health, 1997a).
Trends in prevalence rates for chlamydia are not well established because, while
some states have been reporting the disease since the 1980s, others began as recently as
1995. A national survey of405 facilities indicated that the number of facilities that
provided testing for chlamydia increased, from 160 in 1993 to 288 facilities in 1994, the
year of the survey (Beck-Sague et aL, 1996). In the population from which this study
sample was drawn, the estimated prevalence of chlamydia among pregnant women
during 1995 was 9.1% in those under 14 years old, 8.8% in women aged 15-19 years, and
1


177
pregnancy. While medical records personnel can enter this condition in the other space
provided, the reality is that the word syphilis might raise the index of suspicion and
increase the likelihood that a specimen for serology would be taken, or that the
information contained in the womans medical history would improve reporting of
undetected cases. Ideally, this change should occur at the national level, as the state fetal
death certificate is modeled on the national standard certificate.
Nationally, syphilis is at an all time low and intensive efforts are underway to
eliminate syphilis by the Year 2004. A heightened level of awareness in the provider
community might help achieve this goal. This may be attained through numerous
measures: 1) multi-disciplinary analysis of syphilis case data in the community by nurse
practitioners, physicians, disease investigators and others; 2) an emphasis on dissemination
of findings related to cases that represent multiple missed opportunities for intervention; 3)
dissemination of information to community clinician providers regarding their legal
requirements to screen diming the first and third trimesters, and at delivery as indicated;
and 4) dissemination of current information about the clinical manifestations, diagnostic
classification and treatment guidelines to advanced practice nurses, physician assistants,
and physicians.
Clinicians routinely participate in fetal death and infant mortality review teams.
Numerous findings from this study would suggest that the participation of advanced
practice nurses, infectious disease specialists, or disease investigators knowledgeable in
both sexually transmitted disease prevention activities and womens reproductive health,
might assist to identify other patterns of association and gather the appropriate
documentation.




89
greater than 18 years at the time of delivery and having less than or equal to eleven years
of education completed were value of 1 for the designated risk of not having completed
high school. While an age appropriate score was not assigned to younger adolescents, this
variable does not penalize a young teen for not yet having completed high school at the
time of delivery, or place a younger adolescent within the risk category.
History of past or current STD was created to capture fragmented information
contained in the multiple data sets. Due to distinctly differing rationales to record or not
record any information related to a history of a recent past or present STD, all possible
positive events were captured. However, a woman was only counted once if any field was
positive for any STD event. A report of herpes in this pregnancy from the birth record was
not included. Yes responses were included from the following fields:
1) chlamydia positive or gonorrhea positive on either the mothers laboratory
linked file or the infants file;
2) a morbidity case report for the mother designating a condition of chlamydia,
gonorrhea, pelvic inflammatory disease, primary, secondary or early syphilis;
3) a morbidity case report for the infant designating a condition of chlamydial
opthalmia, gonorrheal opthalmia, chlamydial pneumonia, or congenital syphilis;
Inadequate weight gam was computed from the body mass index (BMI) group,
gestational age in weeks and recommended weight gain ranges in pregnancy for each BMI
group. Any woman not achieving the recommended weight gain was assigned a designator
risk measure of1. (Florida Department of Health, 1999). See Appendix X for more
detail on the applicable calculations.
Marital status was defined as married or unmarried.


128
respectively. Women 14 years and less had the highest rate of low birth weight at 10.1%,
with women over 40 years of age second highest with a rate of 9.6%. The BMI group
within these ages differed regarding which weight group had the highest proportion of the
low birth weight. For the younger age group those with low BMI had the greatest percent
of overall LBW (12.7%). In the older age group, more LBW occurred in women with
high BMI (20.4%). Regardless of race/ethnicity group, the rate of low birth weight was
highest in those groups of women with low body mass index.
Mothers of 1) black race, and 2) a prior poor pregnancy outcome were also
significantly associated with all categories of low birth weight. Having had a STD in the
past, or a positive test for chlamydia and gonorrhea were also significantly associated with
all categories of low birth weight, especially gonorrhea infection.
Descriptive Analysis of 1996 Statewide Gen-Probe PACE2C Results
The data set includes 128,786 laboratory reports of statewide specimens submitted
to the State Bureau of Laboratories and tested by the Gen-Probe PACE2C system for
Chlamydia trachomatis and Neisseria gonorrheae. (Please refer to Table 13.) The
distribution of test results for the time span utilized in accordance with the protocols for
this data set, reveal that the majority of the specimens were collected in the second half of
the time period. Sixty-three of the sixty-seven Florida counties are represented within the
data set. However, the distribution reflects the phased in implementation of computerized
storage of the laboratory records, and the failure of hardware as described in prior
sections. Reports for forty counties individually represent less than 1% of the total test
reports with test volumes ranging from 1 to 1,213 specimens. Twenty counties represent


178
Internet web-based case reporting of sexually transmitted infections may provide
another venue and support an increased index of suspicion for sexually transmitted
infections among clinicians. Such an approach would require that the appropriate changes
be made, in the future, to those Florida Statutes that now direct the reporting of STDs
exclusively through the county health department. Such a model would also provide an
opportunity to collect negative test result denominator data, for use in calculation of
statewide chlamydia prevalence rates (and that of other sexually transmitted infections).
Activities of this type would provide support for the development of active surveillance
systems for sexually transmitted infections.
The findings in this study suggest that there are potential economic implications
from intra-pregnancy infection with chlamydia and other STDs. Examination of these
relationships has been reported by Mittendorf and colleagues (1994). They utilized a
calculation of population attributable risk based on prevalence of the infection in the
population and the odds ratio associated with increased likelihood of low birth weight
from chlamydial infection. Previously, this researcher applied this same methodolgy to the
findings from the pilot study on which the present work was modeled. These calculations
resulted in a cost avoidance estimate of 3.7 million dollars for low birth weight infants
bom during 1995, attributable to universal screening and treatment for chlamydial
infections during pregnancy (Florida Department of Health, 1997c). At a future time, the
economic associations related to the findings in this study should also be analyzed, in
order to estimate cost-benefit and cost-effectiveness through chlamvdia screening. The
implications for public health policy development regarding population-based screening
for chlamydia (and other STDs) may be significant.


26
non-Hispanic black women has declined slightly during this same period from 12.22% to
11.46%. Among white non-Hispanic women, there has been more fluctuation with an
overall trend that has been a slightly upward from 4.60% in 1989 to 4.95% in 1997
(Ventura, Martin, Curtin, & Mathews, 1999). The rate of low birth weight among
adolescents 15 to 19 years old in Florida during 1996 was 1.9% for very low birth weight
and 9.9% for low birth weight. These numbers are comparable to national rates for low
birth weight at 9.5%.
Table 1. Comparison of Percent of Low Birth Weight: Florida and the United States,
1988-1998.
Florida United States
Very Low
Birth Weight
<1,500 Grams
Low Birth
Weight <2,500
Grams
Very Low
Birth Weight
<1,500 Grams
Low Birth
Weight
<2,500 Grams
1988
1.4
7.7
1.2
6.9
1989
1.5
7.7
1.3
7.0
1990
1.5
7.4
1.3
7.0
1991
1.4
7.4
1.3
7.1
1992
1.5
7.4
1.3
7.1
1993
1.4
7.5
1.3
7.2
1994
1.5
7.8
1.3
7.3
1995
1.5
7.7
1.4
7.3
1996
1.5
7.9
1.4
7.4
1997
1.5
8.0
1.4
7.5
1998
1.6
8.1
-
-
Content adapted from Office of Vital Statistics, 1996a, 1999; Ventura, Martin, Curtin, &
Mathews, 1998.
The societal unpact from low birth weight infants is enormous in terms of medical
health care costs and other long-term adverse outcomes. The average cost for the first
year of a low birth weight infants medical care has been estimated to exceed $28,058 (this


121
Table 8. Comparison Between Relational Database and Study Sample of Records
Identified for Use as the Dependent Indicator Variables.
Births
Fetal Deaths
Totals
Relational Database
190,497
1.501
191,998
Study Sample
13,914
88
14,002
Dependent Indicator Variable
#
%
#
%
Low birth weight
(500 2499 grams)
15,437
8.1
963
6.9
Term low birth weight
(1500 -2499 grams and >37 weeks)
4,483
2.4
355
2.6
Pre-term low birth weight
(500 1499 grams and < 36 weeks)
9,001
4.8
478
3.5
Consistent with the age distribution in the two samples presented in Table 4, a
higher percent of young women were captured in the age indicator for the study sample.
The computed inadequate weight gain is nearly one third higher in the study sample,
22.1% compared to 14.6%. The differences between both groups for the prenatal care
indices would suggest that while more women from the study sample entered prenatal care
in the first trimester they may not have met the required number of visits for gestation as
did women in the relational database.
Significantly more women in the study sample did not complete high school.
However the coding on this categorical indicator variable placed those under 18 years who
had not yet completed high school into the same group as those over 18 years who did
complete high school. Hence the younger distribution of the study population therefore
did not contribute to the increase percentages, and this finding represents those who were
over 18 years of age but had not completed high school at the time of the birth event.


30
Two of four species in the genus Chlamydia, Chlamydia trachomatis and
Chlamydia pneumoniae, prefer humans as their natural host Please refer to Figure 2. The
other two species are C. psittaci and C. percorum that prefer birds and lower mammals
respectively. However there is cross-over between human, bird and mammalian strains.
Twenty-three serovars and perhaps eleven variants for Chlamydia trachomatis have been
isolated from human specimen by scientists (Schachter, 1999a; Morre et aL, 1998; Tanner,
Harris, & Pace, 1999; Stamm, 1999).
Developmental Cycle
Due to the unique developmental cycle, chlamydiae merited their own order
Chlamydiales, and a single family, Chlamydiaceae. In their unique growth cycle the
bacteria alternate between two morphologic forms. The elementary body (EB) is adapted
to the extracellular environment, while the reticulate body (RB) is specialized for
intracellular growth processes within the host. The metabolically inactive EB is the
infectious form and the RB the metabolically active or repheating form. There are distinct
steps in the chlamydiae developmental cycle. The first step is attachment of the elementary
body (the infectious particle) to the host cell Second is entry into the cell The reticulate
particle then undergoes morphologic changes, with intracellular replication and growth.
Further morphologic changes of the reticulate particle to elementary bodies, is followed in
the final step with release of the infectious particles (Schatcher, 1999a; Schatcher, 1995).
The steps are illustrated in Figure 3 below.
Wyrick (1998) provides a concise summary of the current body of information on the cell
biology of the chlamydiae gleaned from the scientific community in recent years. The EB


69
state registrars quality assurance office staff (R. Shepard, personal communications, June
30,1999).
Florida Statute section 382.002(7) requires that fetal death certificates record the
death of a product of conception prior to the complete expulsion or extraction from its
mother, if the twentieth week of gestation has been reached. The statute further provides
that every fetal death must be registered within five days after the delivery occurred, and
prior burial, disposition, or removal from the state (Office of Vital Statistics, 1996b). The
funeral director, direct-disposer, or physician/midwife who attended the delivery and is
responsible for registering the record, completes the registration record. The certificate of
fetal death is to be signed by the physician in attendance. The midwife may sign as actually
having attended the delivery but not as to the cause of death. The hospital administrator is
responsible for providing the medical details to the funeral director in charge of the
burial/disposition arrangements. The data entry and quality assurance for the fetal death
registration is the same as for the birth certificate.
The data entry for both files is conducted on personal computers. The two files are
supported by proprietary software and maintained and stored on a mainframe computer
system housed in the Department of Children and Families. Hard copies of the data are
regularly microfilmed. The two files, the birth record and the fetal death record were
extracted in separate programs from their respective databases. Staff in the Department of
Heath then combined these two files after realignment of the fields to create one
continuous birth fetal death record file. In the routine course of operations at the Office of
Vital Statistics these records are maintained separately at all times. Quality assurance
measures are regularly employed to assure that infants initially reported as a birth are not


48
Contribution of psvcho-social and behavioral factors. Psychosocial stress was
examined prospectively by researchers to identify any associations with LBW in a low-
income urban population (Orr, James, Miller, & Barakat, 1996). The researchers used
logistic regression with low, moderate, and high stress dichotomous dependent variables
controlling for exposure to different stressors. The independent stressors included among
others were chronic financial or marital problems, death, divorce, housing, and
employment. Scores were not associated with demographic variables such as race, marital
status or educational level. For all women, exposure to stressors was closely associated
with other clinical and behavioral risks for LBW. There were some different and some
similar associations with low birth weight for blacks and whites. Significant for black
women were smoking, hypertension, hospitalization during pregnancy, low pre-pregnancy
weight, prior pre-term birth, and exposure to stressors. Significant for white women were
smoking, drug use, hypertension, hospitalization during pregnancy, and prior pre-term
birth.
In contrast, another group of researchers reported finding no association between
psychological distress and birth weight for gestational age (Heddegaard, Henrikson,
Sabroe, & Secher, 1996). This prospective population-based study collected measures of
psychological distress at the 16th and the 30th week of pregnancy by questionnaires among
Danish women with singleton pregnancies. Dunkel-Schetter (1998) reviewed numerous
studies conducted with colleagues to highlight their findings and possible mechanisms that
may contribute to interactive processes between pre-term delivery, anxiety, stress, and
stress hormones.


204
infection in sexual partnerships. Journal of the American Medical Association.
276(211. 1737-1742.
Quinn, T. C., Welsh, L, Lentz, A., Crotchfelt, K, Zenilman, J. Newhall, J., & Gaydos,
C.A. (1996). Diagnosis by amp licor per of Chlamydia trachomatis infection in
urine samples from women and men attending sexually transmitted disease clinics.
Journal of Clinical Microbiology. 34(61. 1401-1406.
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In K.K. Holmes, P. F. Sparling, P. A. Mardh, S. M. Lemon, W. E. Stamm, P. Piot
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139
Logistic model two: All CHD without any race indicator PTI.RW The third sub-
sample model in this set examined women identified as having a pre-term low birth weight
infant. Due to missing data on 493 of the 14,002 women in the study sample, 13,509 cases
were included in this analysis and terminated after the 12th step. (Refer to Table 15.).
The gonorrheal infection indicator was eliminated at the 2nd due to low
significance. The chlamydial infection indicator was retained until the 5th step (OR 1.20, p-
value .7937, 95% Cl .3240, 4.3674). Pregnant women in this sub-sample exhibited a
substantially higher risk for PTLBW associated with the following independent variables:
OR 3.40, mother had inadequate weight gain
OR 1.97, a history of a prior poor pregnancy outcome
OR 1.65, a history of any sexually transmitted infections
OR 1.52, mother not married
OR 1.42, a history of medical conditions during pregnancy
OR 1.40, mother weighed less than 5.5 pounds when die was bom
OR 1.26, indices of inadequate prenatal care visits
Again, surprisingly, women in this set also were 32% less likely to experience a
PTLBW infant if the mother was not a high school graduate.
Logistic model three: Women of white race only low birth weight. The third set
included only women of white race. Due to missing data on 91 of the 9,492 white women
in the study sample, 9,401 cases were included in this analysis and terminated after the 12th
step. (Please refer to Table 16.)
With the decreasing sample, all STD related indicators were eliminated at the 7* to
9th step with high odds ratios and excessively wide confidence intervals bridging 1.0. This


188
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Symposium.


218
This is the syntax for creation of final logistic variables.
To group the birth weights as LBW. VLBW and outliers.
This leaves birth weights over 2500 as acceptable but codes as missing those under 500
into the missing group. This based on only 304 (.025%) over 2500 in 1996 cohort, this is
reasonable, but the 784 (.04%) under 500 is not at 20 weeks gestation.
compute BWG=0.
if (BW GE 1500 and BW LE 2499) BWG=1.
if (BW GE 500 and BW LE 1499) BWG=2.
if(BW LE 499) BWG=-1.
missing values BWG (-1).
FORMATS BWG(F8).
VARIABLE LABELS BWG "birth weight group".
VALUE LABELS BWG
.000000000000000 "NBW >2500"
1.00000000000000 "LBW >1500 <2499"
2.00000000000000 "VLBW >500 <1499".
To calculate gestational age
if (LMPD GT 31 or LMPD LT 1) LMPD=15.
compute LMPdays=(LMPY*365.25) + (LMPM*30.4375) + LMPD.
compute CDOBdays=(CDOBY*365.25) + (CDOBM*30.4375) + CDOBD.
compute Gweeks=trunc((CDOBdays-LMPdays)/7).
if (Gweeks GT 42 or Gweeks LT 20) Gweeks=-1.
if (LMPM GT 12 or LMPM LT 1) Gweeks=-1.
if (CDOBM GT 12 or CDOBM LT 1) Gweeks 1.
missing values Gweeks (-1).
compute gestage=trunc((CDOBdays-LMPdays)/7).
VARIABLE S=gweeks
To correct the skewed distribution and treat the "99" values just as other variables for
missing values,
missing values estgest (-1).
if (estgest eq 99) estgest=-l.
FREQUENCIES
VARIABLE S= estgest
/ORDER ANALYSIS .
FREQUENCIES
VARIABLE S=estgest gweeks allgwks


203
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J. T. Grayston, R. G. Rank, G. L. Ridgeway, P. Saikku, J. Schachter & W. E.
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Gakinya, M. N., Waiyaki, P., Cheang, M., Piot, P., Ronald, A R., & Ngugi, E.N.
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Printing Company.
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Achives, Series 900 B000894.
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35
immune response occurs that includes circulating antibodies and cell-mediated responses
with both CD-4 and CD-8 T-helper cells. The CD-4 t-cells potentiate the immune
response. It appears resolution of the infection is supported by CD-8 cells (Brunham,
1999).
Three models predominate among the numerous models for pathogenesis under
consideration (Peeling & Brunham, 1996; Chlamydia Genome Project, 1999). There is a
considerable body of work to support consideration of delayed-type hypersensitivity
(Beatty, Morrison, & Byrne, 1994; Rank, Sanders, & Patton, 1995 Schachter, 1999a). In
this model, re-infection with the same or different serovars leads to inflammation and
scarring of the affected mucous membrane. It is possible that the delayed-type
hypersensitivity (DTH) model may also result from reactivation of latent infection,
possibly triggered by altered levels of steroid hormones. Exogenous progesterone is used
in mouse model studies to enhance uptake of chlamydiae, and one study in ewes suggested
reactivation of latent chlamydial infection after either estrus or progesterone treatment
(Patton & Lichtenwalner, 1998). Others mention that both estrogen and progesterone
enhance the growth, survival, and ascent of Chlamydia trachomatis in female animal
models (Krettek, Arkin, Chaisilwattana & Monif, 1993). While it is unwise to assume
findings from animal studies are directly applicable to human pathogenesis of chlamydiae,
the role of steroids in DTH merits further investigation.
That latent infection can persist has been a controversial topic among researchers.
Some have provided compelling evidence that suggest persistence of a single strain over a
period of two to five years (Dean, Suchland, & Stamm, 1998). This group of researchers
used serial ompl genotyping on recurrent culture-positive specimens and ligase chain


45
Contad of the specimen colledion swab with the vaginal mucosa on exit from the
vagina may introduce confounding inhibitors that interfere with testing equipment and
create frise readings with DNA amplified technologies. Other inhibitors associated with
reduced sensitivity in DNA amplification testing include excessive cervical mucous, talc
from latex gloves, and residual urine remaining after DNA purification (National
Chlamydia Committee, 1999b).
Patient related variables such as age, recent coitus, and topical medications,
lubricants, or spermicides are also potential confounding frdors that may adversely affed
the quality of the specimen submitted for testing (Bauman, 1993; U.S. Department of
Health and Human Services, 1989).
After colledion, the actual management of the specimen can adversely affed the
quality and the findings. If the recommended temperature is not maintained while in
storage prior to transport or during transport the specimen can deteriorate significantly.
For example, failure to maintain chlamydial specimens for culture under refrigeration or
freezing will reduce viability of the baderia and the likelihood of a positive culture result
and failure to incubate gonorrhea culture specimens at the corred temperature and period
of time will reduce their vigor. Submission of small amounts of blood with specimens does
not interfere with hybridization test performance; however, grossly bloody specimens may
interfere with assay performance (Gen-Probe Incorporated, 1994a). Vaginal secrdions
and excessive mucopus have been found to interfere with different screening tests and
assay performance, including Gen-Probe (Celum d aL, 1994).


108
been applied at the third step, the logistic regression modeling. Another option would have
been to select all women who had a laboratory test result for chlamydia with the
Table 4. Total Records Linked to the 1996 Birth and Fetal Death Records.
Birth
Fetal
Death
Healthy
Start
Prenatal
Screen
Maternal
Lab Test
Maternal
Morbidit
y
Infant
Lab Test
Infant
Morbidi
fy
#
%
Linked
_
_
_
_
_
76,959
40.1
Linked
Linked
-
-
-
-
106,336
55.4
Linked
Linked
Linked
-
-
-
7,829
4.1
Linked
Linked
-
Linked
-
-
162
0.1
Linked
Linked
Linked
Linked
-
-
25
0.0
Linked
Linked
-
-
-
Linked
40
0.0
Linked
Linked
-
Linked
Linked
-
16
0.0
Linked
Linked
Linked
-
Linked
-
5
0.0
Linked
Linked
-
-
Linked
-
10
0.0
Linked
Linked
Linked
-
Linked
-
13
0.0
Linked
-
-
Linked
-
-
88
0.0
Linked
-
Linked
-
-
-
461
0.2
Linked
-
-
-
-
Linked
24
0.0
Linked
-
-
Linked
-
Linked
25
0.0
Linked
-
-
-
Linked
-
4
0.0
Totals:
191,998
133,771
8,334
317
27
110
191,998
100%
100%
69.673%
4341%
0.165%
0.014%
0.057%
-
-
assumption that all specimens sent to the Bureau of Laboratories would belong to county
health department patients. While in the vast majority of cases this would be accurate,
there was not a variable field to confirm that this was indeed true within the laboratory
database. A program code was assigned to 90.3% of the laboratory tests. Of these 68.7%
were for prenatal patients, 2.3% for STD, and 17.6% were from family planning clinics.
Additional calculations could have been performed to identify if the test was


125
gonorrheal infection was significantly associated with low birth weight (OR 2.9) and term
low birth weight (OR 4.2) dependent variables. Having a positive test result for gonorrhea
increased the odds of low birth weight by nearly three times, and increased the likelihood
of term low birth weight by more than fourfold. No association was observed for pre-term
low birth weight events. Pooled STDs doubled the odds for all groups of low birth weight
(OR 2.04, OR 2.08, and OR 1.90).
Several indicators were identified as mildly protective in reducing the odds of
LBW. Significant variables included not being a high school graduate and if the mother
was foreign bom. Residing in a rural community and having a stressful life were mildly
protective, but not significant at 95% confidence interval, perhaps an artifact of the data or
result of randomness. Alcohol use at any time during the pregnancy, information taken
from the birth record, was significantly associated with low birth weight (p 0.0000 and OR
0.18). It is likely that this is an unreliable finding in light of the fact that only 1.1 % of all
women in the study sample admitted to alcohol use during pregnancy. Alternatively this
discrepancy may be the result of a coding error. In comparison, 13.6% of women were
identified as having used alcohol during the two months prior to completeing the
Healthy Start prenatal screen (OR 1.69, p <0.0001). Several other variables were found to
only mildly increase the probability of a LBW event. Among these variables were: age
under 18 or over 40 years, a mistimed pregnancy, a short birth interval, inadequate
prenatal care indices, and a medical history. Inconsistency between odds ratios and LBW,
TLBW and PTLBW were noted for the four alcohol and tobacco indicators. Increased
odds were noted for unmarried women and those who themselves were of low birth
weight.


8
Specificity of a test as used in this study is the probability of the Gen-Probe test to
report a negative test in an individual truly not infected with Chlamydia trachomatis or
Neisseria gonorrhoeae.
STD or STI refers to sexually transmitted diseases or infections. In the past this
group of infections was known as venereal diseases. These are the commonly known
STDs and other STDs less well known to clinicians and the public as sexually
transmittable. The commonly known STDs include syphilis, gonorrhea, trichomonas,
chlamydia, and HIV. Cytomegalovirus, hepatitis B and C, group B Streptococcus, and
bacterial vaginosis are among those infections less well recognized as sexually
transmitted. Those infections for which common and reliable testing is available are
routinely reported to state health agencies as required by law. For other less frequently
reported infections, there are generally no reasonably priced and sensitive tests available
for use by clinicians to assist in diagnosis. As a consequence, reporting is dependent upon
clinician recognition of syndromes and diagnosis.
Term low birth weight (TLBW1 is the term used to indicate a live bom infant
whose weight is less than 2,500 grams and 37 or more weeks gestation.
Unsatisfactory specimen indicates a Gen-Probe test specimen that contains
excessive amount of blood, mucous, or other material that interferes with the testing
procedure and is reported as an unsatisfactory specimen.
Very low birth weight (VLBW) is the term used to indicate a live bom infant
whose weight is less than 1,500 grams and less than 37 weeks gestation.


4
possible factor may be the understudied role of sexually transmitted infections in adverse
pregnancy outcomes. A recent study estimates that 4.8% of LBW is attributable to
infection with Chlamydia trachomatis during pregnancy in populations with positive test
results comparable to that observed in statewide samples (Mittendorf et al, 1994).
Purpose of the Study
This investigator and colleagues conducted a prior pilot study with 2,885 birth
records and Chlamydia trachomatis test results during 1997. The findings from this
Florida study found LBW rates were slightly lower in the sample population than in the
statewide population. Among the women with positive test results for chlamydia during
pregnancy, the LBW rate exceeded that of women with negative test results. Adjusted
LBW odds ratios for chlamydia, smoking, and black race were significant at the 95%
confidence level Odds ratios were 2.17, 2.49, and 2.09 respectively. The adjusted odds
ratios of chlamydia and smoking were highest for term LBW. 2.68 and 2.93, respectively.
Therefore this larger study was designed to further examine potential associations
between Chlamydia trachomatis and birth outcomes among a population-based sample of
pregnant women and adolescents who initiated prenatal care through county health
departments.
Research Question
The following research question was asked in this dissertation: What associations)
exist(s) between low birth weight and Chlamydia trachomatis infection during pregnancy?


146
models, logistic regression run was broken into three sub-samples to address the
dependent variables of LBW, TLBW, and PTLBW. Again all models excluded women
with multiple gestation and delivered by Cesarean section. All variables in the fifth model
were again entered into backwards elimination (LR) in the same order. The results of
these final models identified a totally different grouping of associations between the
independent variables and the dependent variables, once inadequate weight gain was
controlled for in the models.
Logistic Model Five: All CHD with race indicator and inadequate weight gain -
low birth weight. The fifth model examined women identified with inadequate weight gain,
controlling for those who did gain the recommended amount for their body mass index
and length of gestation. The low birth weights analysis terminated after the 15th step and
included 3,079 excluding the 21 for missing data. (Please refer to Table 18.)
Prior infection with chlamydia was significantly associated with women who had
not gained adequate weight during pregnancy and delivered a low birth weight infant. The
gonorrheal indicator was eliminated at the 4th step and the STD indicator at the 5th step
due to low significance with OR .9535, p-vahie .9416, 95% Cl .2671, 3.4039 and OR
2.33, p-vahie .0827, 95% Cl .8963, 6.0566, respectively. In addition to the chlamydial
indicator pregnant women in the low birth weight inadequate weight gain sub-sample
exhibited a substantially higher risk for low birth weight associated with the following
independent variables:
OR 2.36, use of alcohol at any time during pregnancy
OR 2.08, mother weighed less than 5.5 pounds when die was bom
OR 1.99, a history of chlamydial infection in pregnancy


165
National guidelines for the management of syphilis state that treatment should be
dosed at an appropriate regimen for the stage of the disease (CDC, 1998b). These same
guidelines do not alter the dosage for pregnant women at different stages of infection.
Plasma concentrations of penicillins are reduced during pregnancy. This is believed to be
the result of increased glomerular filtration and increased renal blood flow. Researchers
recommend penicillin dosages be increased by 50%, especially for severe infections,
except for in the last trimester (Meyer, 1995). Infection with Treponema pallidum in
pregnancy is not generally described in the literature as a severe infection. However, the
birth of an infant with congenital syphilis has long been designated as a sentinel public
health event, suggestive of a failure in the community health system.
This study identified strong associations between pooled STDs and low birth
weight, and also high rates of low birth weight among women with a history of either
infectious or latent syphilis. Additionally, findings from this study suggest that not all
women with syphilis received either appropriate or timely treatment for the time period
examined related to their pregnancies. Other researchers have identified similar patterns of
association between missed infections and no treatment or inadequate treatment,
according to prevailing standards (Reyes, Hunt, & George, 1993). Christian, Lavelle and
Bell (1999) reported on several preschoolers with probable intra-utero acquired syphilis
that was not identified earlier. Nathan et al. (1993) demonstrated a wide range of penicillin
levels in different maternal and fetal compartments. Dorfinan and Glaser (1990) of New
York City, reported on seven congenital syphilis cases first identified at 3 to 14 weeks of
age, secondary to the development of symptoms. Four of the infants and their mothers
were seronegative at delivery, and the other three were not tested at delivery, since the


Data Sources 66
Birth and fetal death records 66
Healthy Start prenatal screen 70
Maternal and infant laboratory test report database 73
Maternal and infant case morbidity database 78
Congenital syphilis database 80
Methodological Issues in the Use of Administrative Databases 81
Definition of Study Variables 83
Methods of Analysis 94
Development of the relational database 94
Descriptive analyses 97
Logistic regression 98
Inclusion and Exclusion Criteria 99
Assumptions 100
Limitations of the Study Design and Methodology 100
Strengths of the Study Design 103
4 RESULTS 104
Results of Linking the Respective Databases 104
Descriptive Comparison of the Relational Database and Study Sample 110
Descriptive Comparison of the Dependent and Independent Variables 120
Bivariate Analysis 122
Descriptive Analyis of 1996 Statewide Gen-Probe PACE2C Results 128
Logistic Regression Results 131
Other STD Related Study Findings of Interest 153
Outcome of Research Question 156
5 DISCUSSION AND RECOMMENDATIONS 157
Analysis and Discussion of Research Findings 158
Implications for Clinical Practice 171
Implications for Public Health Policy 174
Implications for Future Research 179
LIST OF REFERENCES 182
APPENDIX A
VARIABLE LIST 213
APPENDIX B
SYNTAX 218
BIOGRAPHICAL SKETCH 235
vi


210
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Yla-Outinen, A., Lehtinen, M., Romppanen, U., Luoto, H., Rantala, L, & Paavonen, J.
(1990). Chlamydia trachomatis is a risk factor of persistent koilocytotic atypia. In
W. R Bowie (Ed.), Chlamydial infections (pp. 323-326). Cambridge, MA:
Cambridge University Press.
Youngkin, E. Q., & Davis, M. S. (1994). Assessing womens health. In E. Q. Youngkin,
& M. S. Davis (Eds.), Womens health: A primary care clinical guide (pp. 50-59).
Norwalk, CT: Appleton and Lange.


91
Mom LBW at birth was extracted from the Healthy Start prenatal screen question
addressing the mothers recollection of the weight at her own birth. Yes was computed to
a value of1.
Mother of foreign birth Limited information was available in the birth record
regarding the womans place of birth. Besides the 50 states, the record system supports
acceptance of codes for a few other countries and United States territories: Puerto Rico,
Virgin Islands, Guam, Canada, Cuba, Mexico, and the remainder of the world. All
women whose birthplace was coded to one of these were designated as foreign bom. It
was anticipated that this information might be useful in the analysis in light of studies that
have demonstrated a decreased risk of LBW among black foreign bom women and an
increase among United States bom women of black race. Similar findings have been
reported from other studies in populations of Hispanic migrant women.
Mother of black race has been associated with an increased risk for LBW in many
studies. For the purpose of analysis, black race was assigned from the mothers race field
in the birth record. Less than 1% of women were of unknown race, while significantly
higher rates of unknown or missing race were contained within the other files, e.g., 40.4%
of birth records did not have a Healthy Start prenatal screen, and only 4.3% had race from
the laboratory test file. Maternal race was grouped by black, white and other for the
descriptive analyses. For the logistic regression, race was grouped by black and non-black.
Mother resides in a rural area. Conflicting information is available; about the
contribution of a womans place of residence to LBW. Some literature suggests that urban
residence may increase the risk of STDs and of LBW, rural residence may be protective.
This variable was computed based on population of the mothers county of residence, and


2.34, p <0.01). Other risk factors identified as strongly associated with low birth weight in
this population were mother reporting a history of prior poor pregnancy outcome, alcohol
use, smoking, mother having been low birth weight herself
Among women who had adequate weight gain, gonorrhea infection increased the
likelihood of having a pre-term low birth weight infant by more than five times (OR 5.11,
p<0.003). Women of black race and smoking were also significantly associated with low
birth weight in this group.
This study indicates that chlamydia infection in pregnancy is strongly associated
with low birth weight and that along with other sexually transmitted infections is a
significant public health problem that warrants further investigation.
xi


72
Hopkins, & Watkins, 1993). The adverse pregnancy outcomes were birthweight under
2,000 grams and/or birth date of less than 34 weeks from the date of last menses. The
same adverse outcomes were used to develop the initial screening instrument after
examination of neonatal and postnatal death rates from 1991. It was noted that Florida
death rates were high at birth weights below 2,000, and dropped off above this cut-off
point as compared to the more universally used 2,500 grams. Likewise the death rates
level off above 34 weeks between last menses and birth date. The positive predictive value
of each screening tool risk factor was analyzed from the linked birth records and prenatal
screens. Additionally, besides effectiveness of the screening tool to identify women at risk
of an adverse outcome as defined in the analysis, the related workload to the county health
department was considered. At the recommendation of the Healthy Start Advisory
Committee, a few subtle changes were subsequently made to the scoring weights and risk
factors in the revised 1994 form to achieve a predicted positive screening rate of 39.98%
and sensitivity of60.64%.
One copy of the screening instrument is forwarded to the Office of Vital Statistics
for data entry. During 1995 and 1996, the data entry system was constructed to require
that all fields were must enter fields. This data entry system was envisioned as
appropriate to aid evaluation of the instrument and the program in the early phase of
legislative implementation. Any record that was found to have an incomplete data field
was placed in a query status and returned to the local county health department. It was
then the responsibility of the local authorities to contact the appropriate public or private
prenatal care provider and ensure completion of the missing data (K. Freeman, personal
communication, June 30, 1999). During 1997 after the preliminary evaluation, some fields


38
tissues. The study does not conclusively demonstrate how the chlamydiae could actually
cross the intact membrane.
Neuer et aL (1996) have suggested that the development of heat shock proteins
during mouse embryogenesis is a plausible explanation for differentiated expression of
heat shock proteins in early pregnancy using first-trimester decidua and failure of the
embryo to implant or survive. Gencay et aL (1996) isolated Chlamydia trachomatis from
placental tissue. Intra-amniotic chlamydial infection can persist in the absence of clinical
symptoms, in the presence of intact membranes, and following apparent eradication of
chlamydiae (Askienazy-EIbhar, 1996; Morrison, 1996; Ghaem-Maghami, Hay, & Lewis,
1996; Koehler et aL, 1996; Gencay et aL, 1997; Neeper, Patton & Kuo, 1990; Brunham,
Holmes, & Embree, 1990; Cunningham, 1995).
Laboratory Diagnosis of Chlamydial Infections
According to Lennette (1995) there are three approaches to laboratory diagnosis
of infections: 1) direct detection of the organism, 2) cultivation of the organism in a
suitable host and 3) use of serology to obtain evidence of recent infection. Direct
microscopic examination of the live organism that causes the infection, direct fluorescent
antibody technique, and detection of nucleic acids through hybridization or amplification
are acceptable technologies for direct detection of the organism An example of
microscopic examination for a sexually transmitted disease pathogen is darkfield
microscopy of freshly collected specimens from moist or dry lesions and lymph nodes for
Treponema pallidum subspecies pallidum or Direct Fhiorecent Antibody (DFA-TP)
technique for body fluids or lesion exudate (Larson, Hunter, & McGrew, 1991). Other


180
attempt at the original research question should be made with improved databases from
the 1997 or 1998 birth years and more laboratory test results!
The finding of significant relationships between low-birth-weight fetal deaths and
late syphilis cases, that were not previously identified as such, suggests that closer scrutiny
of the data and risk variables within the database would be an appropriate analysis to
conduct. It would also be useful to fink the males identified as infected during the same
time period to the birth and fetal death records in order to examine their possible
association with fetal death and low birth weight events.
An analysis of the relationship between records identified as complicated by herpes
at the time of delivery, and low birth weight, or other fields from the Medicaid database
would provide potentially very useful insights. Linkage between this studys relational
database and other HIV/AIDS databases would provide opportunities for ecological
analyses of related sexual behavior patterns among young reproductive aged women and
rates of adverse pregnancy outcomes.
Closer examination of inadequate weight gain, body mass index, fetal deaths and
published risks related to adverse pregnancy outcomes may identify new findings of
interest in this population. Analysis of the level of WIC services in the study population
compared to the larger group for women with inadequate weight gain may provide useful
insights for programmatic evaluation. Adolescent outcomes identified in this study suggest
other questions such as: 1) is the role of insurance coverage and entry into care, related to
rates of STD infection and low birth weight among adolescents? 2) is there an association
between weight gain during pregnancy, young maternal age and adverse birth outcomes?
or 3) would underweight adolescents pregnancy outcomes benefit from closer scrutiny of


134
Pregnant women in the low birth weight sub-sample exhibited a substantially higher risk
for low birth weight associated with the following independent variables:
OR 2.52, mother had inadequate weight gain
OR 1.88, mother was of black race
OR 1.80, a history of a prior poor pregnancy outcome
OR 1.74, identified as having smoked at any time during pregnancy
OR 1.49, mother weighed less than 5.5 pounds when she was bom
OR 1.48, a history of any sexually transmitted infections
OR 1.21, mother not married
Logistic Model One: All CHD with race indicator TLBW. The second sub
sample model in this set examined women identified as having a low birth weight infant.
Due to missing data on 613 of the 14,002 women in the study sample, 13,389 cases were
included in this analysis of ten steps. Please refer to Table 14.
The chlamydial infection indicator was eliminated at the 2nd step due to low
significance. The gonorrheal infection indicator was retained until the final step (OR 2.16,
p-value .1843, 95% Cl .6929, 6.7371). Pregnant women in this sub-sample exhibited a
substantially higher risk for TLBW associated with the following independent variables:
OR 2.46, mother had inadequate weight gain
OR 1.78, identified as having smoked at any time during pregnancy
OR 1.86, mother weighed less than 5.5 pounds when she was bom
OR 1.86, a history of a prior poor pregnancy outcome
OR 1.85, mother was of black race


28
Table 2. Historical Milestones in the Recognition and Study of Chlamydia trachomatis.
B. C.
Egyptian papyri contain description of trachoma.
18**1 century
John Hunter first described Lymphogranuloma Venereum (LGV).
1907
Halberstaedter and Prowazek stained conjunctival scrapings from
orangutans infected with human trachomatous matter and demonstrated
the presence of inclusions.
1911
Lindner isolated inclusions from the conjunctival of infants, the genital
tracts of their mothers, and the urethras of their fathers.
c. 1930
Chlamydia trachomatis isolated from persons diagnosed with LGV by
Macchiavello. Isolate unfortunately lost before confirmed by others.
1941
Respiratory infection in infants first reported by Botsztejn.
1950s
Chlamydia trachomatis isolated from persons diagnosed with LGV by
Tang and associates and later confirmed by other researchers.
1959
The first isolate of Chlamydia trachomatis from the genital tract (non-
LGV) by Jones, Collier and Smith. Obtained from the cervix of a woman
whose infant had opthalmia neonatorum.
1964
Chlamydia trachomatis recovered from male urethras, in association
with epidemiologic studies of conjunctivitis.
1965
Gordon and Quan developed the first clinically useful laboratory
procedure for diagnosis with a tissue culture isolation technique of
intracytoplasmic inclusions that allowed for results in 48-72 hours.
1966
Dunlap and associates demonstrated that up to one third of men with
nongonococcal urethritis had carriage of Chlamydia trachomatis.
1980s
Affordable and sensitive non-culture tests become widespread.
1990s
Highly sensitive and specific amplified testing available.
Content adapted from Schachter, 1999b; Hammerschlag, 1999; Chemesky, 1999.


96
2. Files A (case morbidity) and B (birth fetal death record) data dictionaries were
compiled.
3. Matching specifications were prepared for files A and B, then compiled. Variables are
selected for the match specifications based on reliability and statistical values.
Probability estimates and cutoff values were calculated for matched and unmatched
pairs.
Initially the iLm and m are guessed or assigned by the user. Subsequently, the
system will estimate the probabilities of each when the first pass is run. The decision
can then be made to adjust the model and the cutoff values. A high value would be
initially given to either a critical field or a known reliable, depending on the matching
specifications and the quality of the data.
4. Indexes for match parameters in each pass were created as described, with altogether
five blocks employed. The blocking of variables allow for grouping sets of records for
comparison, e.g., group all with the same last name, to compare to sex on the first
pass and age on the second. Two of the five blocking algorithms follow:
Block 1 on mothers last name, then first name. The STD exam date specified to be
280 days prior and 180 days after the infants date of birth. Next mothers date of birth
month was compared to the case file date of birth month. The next blocking
specification was by birth address, mothers race, ethnicity, and social security number.
Block 2 began on the social security number followed by the mothers year of birth.
Again, the STD exam date was specified to be 280 days prior and 180 days after the
infants date of birth. The mothers date of birth month was compared to the case file
date of birth month. Last, the mothers last name to case morbidity last name by


105
remain available and will be completed at a later date to support additional analyses and
research questions. The final steps in the analytical progression are presented in Figure 4
below.
The 1996 birth and fetal death record database contained 190,497 births and 1,501
fetal death records. Through the methodology described in the previous chapter, each of
the other respective databases were consecutively matched and linked by the respective
birth or fetal death record number to the individual case records. Different time parameters
were established for the respective files. For the files containing information about the
potential birth mothers, the time spanned March of 1995 through March of 1997. This
time span theoretically allowed for capture of information relative to the prenatal period of
the earliest birth in January 1996 and for a period of 90 days post-partum for deliveries
that occurred at the end of December 1996. For the files containing information for infants
bom in 1996, the time span was from January of 1996 through June of 1997. This time
span theoretically allowed for capture of information relative to the actual birth and for a
period of 180 days post-delivery. Additional quality assurance was conducted within SPSS
subsequent to the Automatch process to ensure that each individually matched record did
not exceed the established time parameters.
From the laboratory database of 108,592 laboratory records meeting the time and
gender parameters established, 27 records were matched to individual infants and 8,334 to
individual mothers. This successfully linked only 4.3% of the mothers test records and
0.00227% of the potential infant records. Very stringent parameters were maintained
throughout the Automatching process. These may have contributed to the lower rate of


166
mother was seronegative during the pregnancy. With the presentation of multi-systemic
disease, each maternal-infant pair was found seropositive upon testing. Berry and Dajani
(1992) reported similar patterns of events that occurred in Michigan and involved 18
infants (35% of the cases reported over the five-year period from 1986 to 1990).
Numerous groups of researchers have also discussed the challenge of accurately detecting
neonatal infection with the commonly available serologic tests for syphilis. Stroll et aL
(1993) and colleagues studied three different assays in a population of 116 neonates and
concluded, no single diagnostic test was sufficiently sensitive to use alone for treatment
decisions. Even the highly sensitive polymerase chain reaction technology is reported at
only 78% sensitivity for congenital syphilis specimens (Grimprel et aL, 1991). These
studies highlight several issues that require additional consideration: 1) consistent
application of serologic screening at delivery for syphilis; 2) appropriate management and
treatment according to guidelines; and 3) more sensitive tests to detect incubating or early
infection in pegnant women and neonates.
Galan, Montalvo and Deaver (1997) reported that only 61% of pregnant women
sustained a positive response to recommended treatment dosages of penicillin during their
pregnancies, concluding that under-treatment may be more common than realized by
clinicians. Two recently published studies have reported similar delays in treatment for
chlamydial infections. One group reported a median duration of 21 days from positive test
results to treatment (Foglia, 1999) Others demonstrated delays of more than two weeks
for 30% and no treatment for another 20% (Schwebke, Sadler, Sutton, & Hook, 1997).
Earlier work with infertility and pelvic inflammatory disease has demonstranted a strong
association between delayed treatment and more severe damage to reproductive structures


132
understand potential differences in observed associations from the bi-variate analysis.
These three breakouts were: 1) women with a low birth weight infant, 2) women with a
term low birth weight infant, and 3) women with pre-term low birth weight infant. All
models excluded women with multiple gestation and delivered by Cesarean section. The
results identified very distinct differences between the independent variables and the
dependent variables of LBW, TLBW, and PTLBW. AH variables in each of the four sets
of models were entered into backwards elimination (logistic regression) in the same order.
They were removed in each run at different steps and in differing order of significance
relative to the sub-samples. A summary follows of the more notable differences observed
related to sexually transmitted infections and the overall most significant associations
identified for increased risk of low birth weight. Nearly all models identified inadequate
weight gain as the most significantly associated independent variable contributing to any
event of low birth weight. The first set was run with a race indicator entered among the
independent variables, coded O for white race and 1 for black race. Tables 14 to 17
present the data at the final step in each logistic model for this set. Where applicable, STD
related indicators are bolded for easier recognition.
Logistic Model One: All CHD with race indicator low birth weight The
first set included all women and a race indicator. The first sub-sample model in this set
examined women identified as having a low birth weight infant. Due to missing data on
161 of the 14,002 women in the study sample, 13,841 cases were included in this analysis
often steps. (Please refer to Table 14.) The chlamydial infection indicator was eliminated
at the 2nd step (OR 1.23, p-vahie .8125, 95% Cl .4040, 3.1771). The gonorrheal infection
indicator was eliminated at the 7th step (OR 1.29, p-value .5718, 95% Cl .5347, 3.1075).


TABLE OF CONTENTS
Page
ACKNOWLEDGMENTS iv
LIST OF TABLES vii
LIST OF FIGURES ix
ABSTRACT x
CHAPTERS
1 INTRODUCTION 1
Problem Statement 1
Purpose of the Study 4
Research Question 4
Definition of Terms 5
2 REVIEW OF THE LITERATURE 9
Epidemiology and Prevalence of Chlamydia trachomatis 9
Epidemiology and Prevalence of Low Birth Weight 25
Biology of Chlamydia trachomatis 27
Developmental Cycle 30
Pathophysiology and Pathogenesis 34
Laboratory Diagnosis of Chlamydial Infections 38
Confounding Factors and Quality of STD Specimens Submitted for Testing 43
Standards on Gen-Probe PACE2C Testing Techniques Within Florida 46
Risk Factors for Low Birth Weight 47
Contribution of Psychosocial and Behavioral Factors 48
Contribution of Physiological and Medical Care Factors 50
Contribution of Sexually Transmitted Diseases 59
3 METHODOLOGY 64
Research Design 64
Protection of Human Subjects 65
Confidentiality 65
v


80
name, and diagnosis. Generally, the age and sex fields have a 98% completion rate, with
race ranging from 80-85%. This difference is the result of absent race/ethnicity
information from private providers. Each of the quality assurance components is
applicable to the discrete study data set time period. This data set provided key variables
for the final study database, and these are presented in Appendix A.
Congenital syphilis database. The congenital syphilis records are the sixth and final
database from which study files were extracted. This database is managed much as the
maternal and infant morbidity database above. However it was separate proprietary system
created circa 1990 and not linked electronically to the maternal or infant case morbidity in
the Sexually Transmitted Disease Management Information System (STD*MIS). The
movement of information into this system differs from that of the morbidity system in one
distinct way. All data entry for the 1996-birth cohort of congenital syphilis cases was done
in the Bureau of STD, unlike the maternal and infant case morbidity that was entered at
the local STD area offices. Additionally the data on each case was initially submitted on
lengthy case worksheets. Bureau of STD personnel then confirmed the details of the
mothers syphilis laboratory test results, her diagnosis, and treatment history. With this
additional information the case determination was made as to whether or not the
submitted congenital syphilis case report was indeed either a true clinical and laboratory
confirmed congenital syphilis case, or a case that met the national surveillance definition
for probable congenital syphilis (CDC, 1998a). The case determination for congenital
syphilis applied to both live infants bom to untreated or inadequately treated infected
women and to syphilitic stillbirths. A positive feature of this database was the close
scrutiny that each case received during the determination process. A limitation of this


97
NYSIIS and SOUNDEX, and the same for first name, street address, city, county, zip,
and race.
5. A frequency analysis is prepared on both files. This allows for a visual inspection of
the probabilities, blocking, and linking variables.
6. Clerical review to inspect the m and u and blocking specifications is conducted.
This guides potential editing of the specifications and continuation of the number of
passes to employ.
At this step, matching probabilities were revised for both files and the automated
match was initiated utilizing five passes on different blocking algorithms with clerical
reviews conducted at each pass. At each review, new cutoff values were assigned
based on the amount of residual unmatched records.
At each pass and clerical review, the matched records, clerical review cases, and
duplicates are removed to prevent repeat matching of a record in a subsequent pass.
7. Extract specifications were prepared for the output files.
After this, the case morbidity file was imported into ACCESS for grooming in
anticipation of the relational database development.
Descriptive analysis. Descriptive analysis was conducted on demographic
variables, prevalence of sexually transmitted infections, and other select variables in the
study population. Sub-populations of county health department clients, specifically women
giving birth to LBW, TLBW and PTLBW infants was then examined according to the
selected variables and presence or absence of a positive test result for chlamydia infection
by frequency, distribution, and consistency between the linked data sets. Bi-variate cross
tabulation was conducted between the dependent variables (LBW, TLBW, and PTLBW)


191
Foglia, G., Rhodes, P., Goldeberg, M., & St. Louis, M. E. (1999). Complteness of and
duration of the time before treatment after screening women. Sexually Transmitted
Diseases1_26(8), 421-426.
Foorghani, B., & Erdman, D. D. (1995). Amplification and detection of viral nucleic acids.
In E. FL Lennette, D. A. Lennette & E. T. Lennette, (Eds.), Diagnostic procedures
for viral rickettsial and chlamvdial infections (pp. 97-120). Washington, DC:
American Public Health Association.
Freund, K. M. (1992). Chlamydial disease in women. Hospital Practice. 2. 175-186.
Galan, H. L., Montalvo, J. F., & Deaver, J. (1997). Retrospective analysis of the serologic
response to the treatment of syphilis during pregnancy. Infectious Diseases in
Obstetrics and Gynecology. 5. 23-28.
Gaydos, C. A., HoweU, M. R., Pare, B., Clark, K_ K., Ellis, D. A.. Hendrix, R. M.,
Gaydos, J. C., McKee, K T., & Quinn, T. C. (1998). Chlamydia trachomatis
infections in female military recruits. New England Journal of Medicine. 339( 11),
739-744.
Gaydos, C. A., HoweU, M. R., Quinn, T. C., Gaydos, J. C., & McKee, K T. (1998). Use
of hgase chain reaction with urine versus cervical culture for detection of
Chlamydia trachomatis in an asymptomatic military population of pregnant and
non-pregnant females attending papanicolaou smear clinics. Journal of Clinical
Microbiology. 36(51 1300-1304.
Gencay, M., Koskiniemi M., Saikku, P., Puolakkainen, M., Raivio, K, Koskela, P., &
Vaheri, A. (1995). Chlamydia trachomatis seropositivity during pregnancy is
associated with perinatal complications. Clinical Infectious Diseases. 21. 424-426.
Gencay, M., Puolakkainan, M., Wahlstom, T., Ammala, P., Mannonen, L., Vaheri, A., &
Koskiniemi M. L. (1997). Chlamydia trachomatis detected in human placenta.
Journal of Clinical Pathology. 50. 852-855.
Gencay, M., Puolakkainen, M., Wahlstrom, T., Ammala, P., Mannonen, L., Vaheri, A.
and Koskmierm, M. (1996, December). Detection of Chlamydia trachomatis DNA
and chlamvdial inclusions using non radioactive in situ hybridization and APAAP
staining of placental samples. Abstract presented at International Symposium on
Immunopathogenesis of Chlamydia Infections, New York, NY. Infectious Diseases
in Obstetrics and Gynecology, 4. 194-210.
GenProbe Incorporated. (1994a). Gen-Probe PACE2: Chlamydia trachomatis.
[Package Insert] San Diego, CA: Author.


170
the highest body mass index group, suggesting that associations with health outcomes may
be wider than those observed in this study (Calle, et aL 1999).
Fetal and infant mortality review projects completed within Florida, have reported
obesity and poor nutrition among the top five factors most commonly present in cases of
fetal and infant deaths occurring in Florida (Bellamy, 1998). A similar finding was not
supported by this study for fetal deaths. Overwhelmingly, more than half of the fetal
deaths occurred to women with normal body mass index and adequate weight gain during
pregnancy. Among those who did not gain enough weight, already underweight women
were most adversely affected; however, the numbers are very small.
Several researchers have suggested that the maternal self-report of their pre-
pregnancy weight, and their total weight gain in the pregnancy may have biased the
findings (Yu & Nagey. 1992; Schieve et aL, 1998; Hickey et aL, 1996). They also discuss
the work of others who have observed that self-reported weight measures correlate well
among non-pregnant women, and that under and average weight women are less likely to
underreport than are obese women.
Inadequate prenatal care visits was not a strongly associated risk factor in this
population. Some recent literature has suggested that the counting of prenatal visits has
not demonstrated a clear association of benefit in reducing adverse pregancy outcomes. It
is plausible that records within this data set had incomplete information regarding timing
and adequacy of visits. Other studies have demonstrated overall accuracy to be as low as
14.3% when birth cerifcate and medical records are compared (Clark, Fu, & Burnett,
1997). Similarly, error may have occurred in the coding of birth weight (Rm skill 1990).


187
Chemesky, M. A., Luinstra, K., Sellors, J., Schachter, J., Moneada, J., Caul, O., Paul, L,
Mikaelian, L., Toye, B., Paavonen, J., & Mahony, J. (1998). Can serology
diagnose upper genital tract chlamydia trachomatis infection? Studies on women
with pelvic pain, with or without chlamydial plasmid dna in endometrial biopsy
tissue. Sexually Transmitted Diseases. 25(1). 14-19.
Chlamydia Genome Project. (1999, July 8). Available: www:http:// chlamydia-www.
berkelev.edu:4231/
Christian, C. W., Lavelle, J., & Bell, L. M. (1999). Preschoolers with syphilis. [Abstract],
Pediatrics. 103(11. 142.
Clark, K., Fu, C-M., & Burnett, C. (1997). Accuracy of birth cetificate data regarding the
amount, timing and adequacy of prenatal care using prenatal medical records as
referents. American Journal of Epidemiology. 145(1). 68-71.
Cnattingius, S., & Haghmd, B. (1997). Decreasing smoking prevalence during pregnancy
in Sweden: The effect on small-for-gestational-age births. American Journal of
Public Health. 87(31. 410-413.
Cohen, L, Tenenbaum, E., Michaeli, G., Beyth, Y., & Sarov, I. (1990a). Serum-specific
antibodies for Chlamydia trachomatis in preterm premature rupture of the
membranes. Gynecologic and Obstetric Investigation. 30. 155-158.
Cohen, I., Veille, J-C., & Calkin, B. M. (1990b). Improved pregnancy outcome following
successful treatment of chlamydial infection. Journal of American Medical
Association. 263(231. 3160-3163.
Collins, J. W., & David, R_ S. (1990). The differential effect of traditional risk factors on
infant birthweight among Blacks and Whites in Chicago. American Journal of
Public Health. 80161. 679-681.
Collins, J. W., & David, R_ S. (1993). Race and birthweight in biracial infants. American
Journal of Public Health. 83(81. 1125-1129.
Committee on Unintended Pregnancy. (1995). The best intentions: I Jnintended pregnancy
and the well-being of children and families (S. S. Brown & L. Eisenberg, Eds.).
Washington, DC: Institute of Medicine.


109
collected during the pregnancy. However a third option existed to identify the women as
county health department patients. This was the provider code contained within the
Healthy Start prenatal screen data fields. This method was selected to identify the records
Table 5. Study Sample Records Linked to the 1996 Birth and Fetal Death Records.
Birth
Fetal
Death
Healthy
Start
Prenatal
Screen
Maternal
Lab Test
Maternal
Morbidity
Infant
Lab Test
Infant
Morbidity
#
%
Linked
Linked

_
9,241
66.0
Linked
Linked
-
Linked
-
-
19
0.1
Linked
Linked
Linked
-
-
-
4,702
33.6
Linked
Linked
Linked
Linked
-
-
17
0.1
Linked
Linked
-
-
-
Linked
8
0.1
Linked
Linked
-
Linked
-
Linked
2
0.0
Linked
Linked
Linked
-
-
Linked
1
0.0
Linked
Linked
-
-
Linked
-
2
0.0
Linked
Linked
Linked
-
Linked
-
10
0.1
Totals:
14,002
14,002
4,730
38
12
11
14,002
100
100%
33.7809%
0.2714%
0.0857%
0.07856%
-
-
of women who received county health department prenatal services for sample extraction.
There are differences in the odds ratios, confidence intervals and p values. It is possible
that inclusion of all women with positive test results for chlamydia would have changed
the findings in some way.
The methodology outlined in Chapter 3 was used to direct the linkage of records.
It was stringent and time consuming in order to achieve the level of accuracy attained. The
cut-off points for each step in the AUTOMATCH processes were maintained and as a
result the time required for visual audits on decision to include or exclude records that


232
1 "<14"
2"15-19"
3 "20-24"
4"25-29"
5 "30-34"
6"35-39"
7 "40-44"
8"45-49"
99 "unk".
Execute.
To recode race for mom from birth file.
compute BMrace=MRACE.
recode BMrace (1=1) (2=2) (else=0).
missing values BMrace (-1).
FORMATS BMrace (F8).
VARIABLE LABELS BMrace "birth mom's race (CHD)".
VALUE LABELS BMrace
.000000000000000 "other"
1.00000000000000 "white"
2.00000000000000 "black" .
execute.
To recode infant hirthrace for CHD sample file
compute BCrace=CRACE.
recode Bcrace (1=1) (2=2) (else=0).
missing values BCrace (-1).
FORMATS BCrace (F8).
VARIABLE LABELS BCrace "birth infant's race (CHD)".
VALUE LABELS BCrace
.000000000000000 "other"
1.00000000000000 "white"
2.00000000000000 "black .
execute.
To recode race mom morbidity file.
compute BMrace=MRACE.
recode BMrace (1=1) (2=2) (else=0).
missing values BMrace (-1).
FORMATS BMrace (F8).
VARIABLE LABELS BMrace "morbidity mom's race (CHD)".
VALUE LABELS BMrace
.000000000000000 "other"
1.00000000000000 "white"
2.00000000000000 "black" .


18
those infants with infection who were not treated as compared with 11.0% that were
treated (Ryan, Abdella, McNeeley, Baselski, & Drummond, 1990). This finding was highly
significant, at 95% Cl, p<0.0001. Others found an odds ratio of 1.5 for low birth weight
associated with chlamydia positivity (Gravett et al, 1986). Harrison et aL (1983) identified
the presence of IgM antibodies among infants bom with low birth weight in a population
with 8% prevalence on culture. Martius et aL, (1988) reported an even higher odds ratio
of 3.9 for chlamydia positive pregnancies to be associated with premature rupture of
membranes or pre-term labor.
Investigators of the Johns Hopkins Study of Cervicitis and Adverse Pregnancy
Outcome reported an odds ratio of 2.4 for intrauterine growth retardation in a population
with 15.5% positivity (1989). In contrast, Germain and colleagues (1994) found no
association when cultures were taken at 23-26 weeks. Cohen, Veille, and Calkins (1990)
identified a non-significant reduction in low birth weight and small-for-gestational-age
infants among another treated group when compared to non-treated controls. Hardy et aL
(1984) only found association for chlamydial infection and low birth weight if co-infected
with Trichomonas vaginalis. One unique aspect of this study however was the destruction
of the chlamydial McCoy culture cells by the protozoa. This aspect may have confounded
the findings of a lack of an association between low birth weight and chlamydia infection.
In 1991, Much and Yeh observed a significant difference in the incidence of low birth
weight between two groups when one was treated with erythromycin, p <0.05. Clearly
additional data is needed to help clarify the relationship between chlamydial infections
during pregnancy and adverse outcomes.


206
Schmitt. K. (1999). [1998 Positivity rates for chlamydial and gonorrhea infections among
counties participating in the Florida infertility prevention project]. Unpublished raw
data, Florida Department of Health, Tallahassee.
Scholl, T. O., Hediger, M. L., Huang, J., Johnson, F. E., Smith, W. & Anees, I. G. (1992).
Young maternal age and parity. Influences on pregnancy outcome. Annals of
Epidemiology. 2(51: 565-575.
Schulz, K F., Schulte, J. M., & Berman, S. M. (1992). Maternal health and child survival:
Opportunities to protect both women and children from the adverse consequences
of reproductive tract infections. In A. Germain, K. K. Holmes, P. Plot, & J. N.
Wasserheit (Eds.), Reproductive tract infections (pp. 145-182). New York, NY:
Plenum Press.
Schwebke, J. R., Sadler, R., Sutton, M., & Hook, E. W. (1997). Positive screening tests
for gonorrheand chlamydia infection fail to lead consistently to treatment of
patients attending a sexually transmitted disease clinic. Sexually Transmitted
Diseases. 24(4). 181-184.
Schwebke, J. R., & Zajackowski, M. E. (1996). Comparison of DNA probe (Gen-Probe)
with culture for the detection of Neisseria gonorrhoeae in an urban STD
programme. Genitourinary Medicine. 72. 108-110.
Seidman, D. S., Ever-Hadani, P., & Gale, R. (1989). The effect of maternal weight gain in
pregnancy on birth weight. Obstetrics and Gynecology, 74. 240-246.
Serow, E., Jones, M., & Luke, G. (1996). Healthy start healthier outcomes: Annual
report 1996. Tallahassee: Florida Department of Health.
Sexton, M., & Hebei, R. H. (1984). A clinical trial of change in maternal smoking and its
effect on birthweight. Journal of the American Medical Association. 251. 911-915.
Shakarishvili, A. (1995, August). Chlamydia trachomatis in economically disadvantaged
young women across the U.S.: Findings from the US Job Corp. 1990-1994. Paper
presented at the Eleventh Meeting of the International Society for STD Research,
New Orleans, LA.
Shiono, P. H. Klebonoff M. A., & Nugent, R.P., Cotch, M. F., Wilkins, D. G, Rollins, D.
E., Carey, J. C., & Behrman, R. E. (1997). The impact of cocaine and marijuana
use on low birth weight and preterm birth: A multicenter study. American Journal
of Obstetrics and Gynecology, 172Q-P1L 19-27.
Shultz, R. A., Arndt, V., Olshan, A. F., Martin, C. F., & Royce, R. A. (1998). Effects of
short interpregnancy intervals on small-for-gestational age and preterm births.
Epidemiology. 10131. 250-254.


71
Jacksonville, Florida. The source document for this data set is the Healthy Start prenatal
screen. All prenatal care providers are required by law to administer the screening
instrument to pregnant women, preferably at their initial prenatal visit. The screening
instrument collects demographic information and responses to a series of risk questions.
The questions are based on medical, psychosocial, and environmental factors associated
with increased risk of poor pregnancy outcomes. A score is calculated based on the risk
factor, and the strength of the risk as a predictor of poor outcomes (Serow, Jones, &
Luke, 1996). In addition to the demographic, medical and provider information collected,
the psychosocial and environmental variables capture risk information about educational
level, access to care, housing, and food, drug, alcohol and tobacco use, risk of domestic
violence, and perceived level of personal stress.
The particular risk factors included were initially based on extensive review of
the literature and an evaluation of birth and fetal death records for associations commonly
observed in the Florida population among low birth weight infants and infant deaths. Two
different years of birth records were evaluated in development of the prenatal screening
instrument utilized since 1994. The 1989 birth and fetal death records were used to
calculate risk ratios on commonly held risk associations, e.g., age less than 18 years, age
over 39 years, unmarried, etc. If a factor occurred in more than 1,000 births and had an
associated risk ratio of greater than twice the average risk, then it was considered a
potential risk factor and included in the initial screening instrument (Thompson,
Hopkins, & Watkins, 1993).
After the first two years of use, a second evaluation utilized the prenatal screens
and the birth records for the period between April 1, 1992 and April 30, 1993 (Thompson,


57
PTLBW and increased associated costs). They also noted that women with private
insurance were more likely to have higher costs and longer stays overall.
In contrast, Larson, Hart and Rosenblatt (1997) found no association with
residence in a non-metropolitan area for LBW or VLBW They did observe an adverse
effect for neonatal mortality and post-neonatal mortality. However, on logistic regression
non-metropolitan residence was not associated with either LBW or neonatal mortality.
Alexy, Nichols, Heverly, and Garzn (1997) reported that rural or urban residence did not
predict LBW. They found race, weight gain, number of total prenatal care visits, and
adequacy of diet resulted in stronger associations to predict LBW. O Campo and
colleagues (1997) conducted muti-level modeling to examine macro (census tract) and
individual risk factors. They noted all individual level risk factors for LBW had a different
effect dependent on the neighborhood of residence. They suggested that housing, crime
and unemployment modify the relationship of urban or rural residence to LBW.
Researchers examined the inter-pregnancy intervals (IPI) of small for gestational
age (SGA) and pre-term births among a North Carolina population of blacks and whites
(Shultz, Arndt, Olshan, Martin, & Royce, 1998). Three categories of IPI were created: 0-
3 months, 4-12 months, and 13-24 months. Those with IPI of greater than 24 months
were excluded, due to the possibility of sub-fecundity and potential increased risk for low
birth weight. Race specific logistic models were used and population attributable risks
calculated. Evaluation of single month intervals indicated that the odds ratio for SGA
infants was elevated for each until 10-12 months, and decreased with increasing IPI. There
was no consistent pattern for pre-term birth associations using the single month
incremental analysis. Overall they found a moderate association (OR 1.6) between SGA


Ill
linked to laboratory tests or case morbidity records. This disparity' reflects that 40% of
women who delivered in 1996 did not receive a Healthy Start prenatal screen, and that
only records for with a Healthy Start prenatal screen that indicated they had initiated care
at county health departments were selected for the study sample.
The actual percent of women who were both offered and accepted prenatal
screening, and delivered a live infant or experienced a fetal death during 1996 is unknown
for comparison. During 1995 to 1997, the percent of women who were both offered and
accepted prenatal screening ranged from 67.5% to 70.6%. This number includes women
who were screened during their pregnancy for those time periods, but does not necessarily
indicate that the woman delivered during the same year that they received the prenatal
screening.
Seventy-five percent of births or fetal deaths occurred to women of the general
population between the ages of 20 and 34 years. Please refer to Table 6. In comparison a
similar proportion of the 1996 births or fetal deaths occurred to a younger segment of
women in the sample population; 74% between the ages of 15 and 30 years. The
downward shift to a younger age is reflected in the sample where the proportion with
age at delivery between 15 and 19 years is more than double the corresponding proportion
in the database. The distribution of age and race indicated that twice as many of the 129
women 14 or less years of age were of black race/ethnicity (data not shown). Twice as
many were of white or other race/ethnicity for the 15-19 year old group, as were those in
the 35 to 44 year old groupings. Race was evenly distributed among women between the
ages of 20 to 34 years; three quarters were of white race/ethnicity.


208
Stephens, R. S., Byme, G. L, Christiansen, G., Clarke, L N., Grayston, J. T., Rank, R. G,
Ridgeway, G. L., Saikku, P., Schachter, J., & Stamm, W. E. (Eds.) (1998).
Chlamydial infections: Proceeding of the ninth international symposium on human
chlamydial infection. San Francisco, CA: International Chlamydia Symposium.
StolL S. J., Lee, F. K, Larsen, Hale, E., Schwartz, D., Rice, R. J., Ashby, M., Holmes, R.,
& Nahmias, A J. (1993). Clinical and serologic evaluation of neonates for
congenital syphilis: A continuing diagnostic dilemma. The Journal of Infectious
Diseases. 167. 1093-1099.
Stringer, M. (1998). Issues in determining and measuring adequacy of prenatal care. J
Perinat, 18(11. 68-73.
Suitor, C. W. (1997). Maternal weight gain: A report of an expert work group. Arlington,
VA: National Center for Education in Maternal and Child Health.
Tanner, M. A, Harris, J. K., & Pace, N. R. (1999). Molecular phylogeny of Chlamydia
and relatives. In R. S. Stephens (Ed.), Chlamydia: Intracellular biology,
pathogenesis, and immunity fpp 1-8). Washington, DC. American Society for
Microbiology.
Teutsch, S. M. & Churchill, R. E. (Eds.). (1994). Principles and practice of public health
surveillance. New York, NY: Oxford Press.
Thomas, G. B., Jones, J., Sbarra, A. J., Cetrulo, C., & Reisner, D. (1990). Isolation of
Chlamydia trachomatis from amniotic fluid. Obstetrics and Gynecology, 76I3P21.
519-520.
Thompson, D. R. (1993, July). Developing a prenatal risk criteria for Florida. Paper
presented to the Healthy Start Advisory Committee, Orlando, FL.
Thompson, D. R. (1995). Low birth weight and the interval between pregnancies: Florida
resident live births. 1994. Available: www: http://
doh.state.flus/planning_eval/phstats/papers & articles/.
Thompson, D. R_, Hopkins, R. S., & Watkins, S. M. (1993). Using the birth record to
develop a screening instrument for infant mortality and morbidity. Florida Journal
Public Health. V(1L 4-7.
Thorp J. M., Katz, V. L., Fowler, L. J., Kurtzman, J. T., & Bowes, W. A (1989). Fetal
death from chlamydial infection across intact amniotic membranes. American
Journal of Obstetrics and Gynecology, 161. 1245-1246.
Turrentine, M. A, Troyer. L., & Gonik, B. (1994). Randomized prospective study
comparing erythromycin, amoxicillin, and clindamycin for the treatment of


140
Table 16. Adjusted Odds Ratios, Based on Logistic Regression, for White Race.
Low Birth Weight
Variable
OR
95% Cl
p value
Inadequate weight gain
2.65
2.19, 3.21
0.0000
Married not
1.28
1.06, 1.55
0.0108
Medical history
1.38
1.06, 1.81
0.0176
Mom foreign bom
1.28
1.02, 1.61
0.0364
MomLBW
1.38
1.04, 1.83
0.0259
Prior poor pregnancy outcome
1.56
1.26, 1.94
0.0000
Smoking from birth record
1.87
1.52, 2.31
0.0000
Term Low Birth Weight
Variable
OR
95% Cl
p value
Alcohol use from Healthy Start screen
1.59
1.13, 2.24
0.0078
Inadequate weight gain
2.45
1.82, 3.31
0.0000
MomLBW
1.53
1.01,2.30
0.0434
Prior poor pregnancy outcome
1.59
1.15, 2.18
0.0045
Smoking from birth record
2.17
1.61, 2.92
0.0000
Pre-Term Low Birth Weight
Variable
OR
95% Cl
p value
Inadequate weight gain
3.75
2.89, 4.87
0.0000
Married not
1.38
1.06, 1.80
0.0161
Medical history
1.73
1.21, 2.46
0.0024
Mom foreign bom
1.44
1.05, 1.98
0.0255
Prior poor pregnancy outcome
1.43
1.06, 1.93
0.0178
Smoking from Healthy Start screen
1.68
1.25, 2.23
0.0006
reflects the inadequate power in this variable, with insufficient positive test results to
accurately predict associations. The following independent variables were associated with
an increased risk of low birth weight among white women:


I certify that I have read this study and that in my opinion it conforms to
acceptable standards of scholarly presentation and is fully adequate, in scope and quality,
as a dissertation for the degree of Doctor of Philosophy.
Sharleen H. Simpsonl Chair
Associate Professor of Nursing
I certify that I have read this study and that in my opinion it conforms to
acceptable standards of scholarly presentation and is fully adequate, in scope and quality,
as a dissertation for the degree of Doctor of Philosophy.
Donna M. Treloar
Associate Professor of Nursing
I certify that I have read this study and that in my opinion it conforms to
acceptable standards of scholarly presentation and is fully adequate, in scope and quality,
as a dissertation for the degree of Doctor of Philosophy.
ms J. Malasanos
Distinguished Service Professor
ofNursing
I certify that I have read this study and that in my opinion it conforms to
acceptable standards of scholarly presentation and is fully adequate, in scope and quality,
as a dissertation for the degree of Doctor of Philosophy.
arles S. Mahan
Dean, College of Public Health
University of South Florida
I certify that I have read this study and that in my opinion it conforms to
acceptable standards of scholarly presentation and is fully adequate, in scope and quality,
as a dissertation for the degree of Doctor of Philosophy.
~\ y
V
James P. Stansbury
Assistant Professor of Anthropology


215
Appendix A Continued.
Original Variable
Name
New Variable
Name
Variable labels
WTKELOGM
WTKILOGM
moms weight in kilograms
HTMETER
HTMETER
moms height in meters
BMI
BMI
moms (bmi) body mass index
RACELABI
RACELABI
infants race on lab test
ETHLAB1
ETHLABI
infants ethnicity on lab test
CHD PROG
CHD code
program codes
CTLABINF
CTLABINF
chlamydia test result
GCLABINF
GCLABINF
gonorrhea test result
YLABEXI
YLABEXI
year of lab test
MLABEXI
MLABEXI
month of lab test
DLABEXI
DLABEXI
day of lab test
BFD C
BFD C
b or fd designation for infant lab record
V185
V185
certificate number infant lab
VI86
V186
bfd number infant lab
CUY B
CITY B
city for infant morbidity
INFPAT
INFPAT
infant case patient number
INFMORB
INFMORB
infant case morbidity number
DIAGNOSI
DIAGNOSI
infant diagnosis
RPTDATE
RPTDATE
report date 1
RPTDAT1
RPTDAT1
report date 2
RPTDAT2
RPTDAT2
report date 3
DATEEXAM
DATEEXAM
exam date 1
DATEEX1
DATEEX1
exam date 2
DATEEX2
DATEEX2
exam date 3
DATERPT
DATERPT
date reported as a case 1
DATERP1
DATERP1
date reported as a case 2
DATERP2
DATERP2
date reported as a case 3
DATETREA
DATETREA
date of treatment 1
DATETR1
DATETR1
date of treatment 2
DATETR2
DATETR2
date of treatment 3
TREATMEN
TREATMEN
treatment used
BFD D
BFD D
b or fd designation for infant case morbidity
V206
V206
certificate number infant case morbidity
V207
V207
bfd number infant case morbidity
LABRACEM
LABRACEM
moms lab race
PROGCODE
PROGCODE
mom program code
CTRESULM
CTRESULM
chlamydia test result
GCRESULM
GCRESULM
gonorrhea test result
YLABCOLM
YLABCOLM
year of lab test
MLABCOLM
MLABCOLM
month of lab test
DLABCOLM
DLABCOLM
day of lab test
BFD E
BFD E
b or fd designation for mom lab record
V216
V216
certificate number mom lab
V217
V217
bfd number mom lab
MOMPAT
MOMPAT
mom pah ait number
MOMMORB
MOMMORB
mom morbidity number
V220
V220
mom diagnosis
MOMCASE
MOMCASE
mom case number
YMOMREPT
YMOMREPT
year of report
MMOMREPT
MMOMREPT
month of report
DMOMREPT
DMOMREPT
day of report
YEXMOM
YEXMOM
year of exam
MEXMOM
MEXMOM
month of exam


36
reaction assays on selected intervening culture-negative specimens. In recent years other
researchers have used either culture or DNA amplification to examine persistent infection
concluding that persistence of infection is not supported (National Chlamydia Committee,
1999a). Hopefully, more conclusive evidence will be forthcoming in the future from
researchers.
A suggested alternate model is one of an inflammatory response mediated by
human heat-shock proteins and chlamydial heat-shock protein-60 or -70. Chlamydiae
evoke persistent host cell production of these pro-inflammatory cytokines. Strong
serologic levels of chsp-60 in severe pathology were observed by some groups and
reduced serologic response in other groups with milder pathology (Rasmussen et aL,
1997; Morrison, Lyng, & Caldwell, 1989; Patton et aL, 1994). Witkin and colleagues
(1997) suggested that this same model may contribute to the reduced success with in vitro
fertilization and embroyo transfer observed among women with high levels of cervical IgA
antibodies to Chlamydia trachomatis. Other researchers question if the chlamydial heat
shock proteins are causally involved in chlamydial immunopathogenesis or merely markers
of persistent infection (Peeling & Brunham, 1996).
The third model for pathogenesis of Chlamydia trachomatis is one of genetic
susceptibility (Brunham, 1999; Peeling & Brunham, 1996). In this model the data
examined supported individual differences in immune responses. Those individuals with
weak cell-mediated and strong antibody response were susceptible to re-infection, slower
to resolve, and demonstrated more inflammation and disease. In contrast, those individuals
with a strong cell-mediated immune response and lower antibody response were less
susceptible to both the infection and disease. While the numerous models continue to be


167
(Hillis et al, 1993). Perhaps an association exists between chlamydia pathogenesis and the
timing of treatment. This question merits further study.
The distribution of inadequate weight gain indicated that fewer women of black
race/ethnicity were underweight when compared to women of white race/ethnicity. Black
women were more likely to be of either high or obese body mass index. A greater percent
of black women were obese among women over 34 years of age. Other researchers have
reported this same finding. Among the very youngest of mothers, (129 records < 14 years)
more black women were underweight, 69.1% compared to 30.9%. It was this same age
group that had the highest rate of low birth weight, 12.7% in the study sample. It was also
among this younger age group, those under 14 years of age, that the rate was highest, with
42.6% of 129 young women underweight. Scholl and colleagues (1992) reported an
adjusted odds ratio of 5.74 for small-for-gestational-age, among adolescents of younger
age and low pre-pregnancy body mass. The interactions between maternal age and
pregnancy weight gain remain to be explored with this data.
No information was available in this relational database to identify if these
adolescents were less than two years postmenarche. Some conflicting research has
suggested that a potential association may exist between the interval from menarche, onset
of pregnancy and a metabolic state of developmental growth in the very young adolescent
(Suitor, 1997; Institute of Medicine, 1992). Additionally, some research suggests that the
very young pregnant women may be at a higher risk of a slow rate of weight gain during
pregnancy (Institute of Medicine, 1992). Maternal eating disorders such as anorexia
nervosa, bulimia and bulimia nervosa, place a woman at increased risk of weight gain
abnormalities (Institute of Medicine, 1992). No information was available within this study


17
infiltration of the endometrium. This raises the possibility that such infections are
associated with failure of implantation or early pregnancy loss due to spontaneous
abortion. However, Sozio and Ness (1998) do not support a relationship between acute
chlamydial infection and the subsequent development of spontaneous abortion.
Bell and others (1994) examined the perinatal transmission in relationship to mode
of delivery. With the use of both culture and serology, they concluded that chlamydia may
be transmitted more often than is suggested by other reports. The transmission rate to the
infant was 60% among infected women delivering vaginally (75 of 125 infants). Those
women who delivered by caesarian section were not significantly less likely to be infected
than those delivered by the vaginal route with cephalic presentation, however the numbers
studied were small (10 infants delivered by caesarian section). Two of ten infants (20%)
delivered by caesarian section were later found to be infected in the conjunctiva or
nasopharynx. Cord blood was tested for IgM antibody to Chlamydia trachomatis for 26
of the infants included in the study. In all cases the cord serology was negative; a positive
IgM which would have indicated prior intrauterine infection.
As with other adverse outcomes of pregnancy, the causal link between known
infection with Chlamydia trachomatis and LBW has not been conclusively established.
Recent studies have shown an increased risk of low birth weight and premature rupture of
the membranes linked to recent chlamydial infection while others failed to identify any
associations. Gencay et aL (1995) reported that gestational age was longer among IgG
and IgM sero-negative infants. They also found less chorioamnionitis and atelectasis and
pneumothorax among the sero-negative group. In another study designed to examine the
effect of treatment on pregnancy outcome, low birth weight was reported in 19.6% of


44
1989). For example, unavailability oflarge drum swabs reduce the ease with which a
clinician can adequately and efficiently clean the cervix of excess exudate or blood. In one
study the use of the cytobrush to collect chlamydial specimens improved the rate of
adequate endocervical specimens but not the sensitivity' of the enzyme-linked
immunosorbent assay used (Kellog, Seiple, Klinedinst, & Levisky, 1992). In contrast,
Moneada and colleagues (1989) observed improved sensitivity for both direct flourescent-
antibody and enzyme-linked immunosorbent assays with use of the cytobrush. Another
group of researchers who compared swab type and storage temperature reported that
calcium alginate swabs were toxic to Chlamydia trachomatis and herpes simplex virus and
that cotton on wood appeared to be inhibitory to chlamydiae (Mahony & Chemesky,
1985). The authors also cite others who reported that wooden shafts were toxic to
Ureaplasma urealyticum and Neisseria gonorrhoeae (Mardh & Zeberg, 1981 as cited in
Mahony & Chemesky, 1985). Their concluding recommendation was to use cotton, rayon
or dacron tips on aluminum or plastic shafts to increase the viability of specimens for
culture.
Training and skills of those sampling the cervix is variable and may affect the
quality of the specimen collected. The timing and force with which a swab is rotated
within the cervical os may dictate the likelihood of retrieval of adequate numbers of
columnar cells, and adversely impact on a positive finding for direct detection tests with
lower sensitivity. Because Chlamydiae are obligate intracellular parasites, one must collect
the appropriate host cells, columnar epithelial cells located in the cervical os, or at the
transition zone. Additionally, the clinician needs to apply adequate pressure and vigorous
swabbing to obtain the infected cells (Schachter, 1990).


5
Definition of Terms
The following definitions were used in this study.
Asymptomatic refers to an absence of symptoms e.g., discharge from urethra or
vagina, vulvar itching, intermittent pelvic pain, change in menstrual flow or consistency,
burning on urination, or vaginal discharge with an odor. Symptoms are different from
signs that the clinician identifies as indicative of the presence of infectious processes e.g.,
frothy green discharge versus adherent white clumping discharge, painless ulcer
visualized on the surface of the cervix, or palpable mass on the ovary. At times symptoms
may be present but the individual may not recognize them as such due to their frequency
of occurrence, or unawareness of their relevance in regard to their health, e.g., inter-
menstrual spotting.
Chlamydia is the common term used to refer to Chlamydia trachomatis. It is the
most common sexually transmitted infection in the United States, capable of causing
long-term adverse and permanent sequelae.
Chlamydia trachomatis is an obligate intracellular parasite that requires a host cell
in order to live and reproduce. In the context of this study those serovars that cause
genital and congenital infections are the reference. Several other serovars are the cause of
lymphogranuloma venereum or LGV.
DNA hybridization is a laboratory technique used to increase the likelihood of
detecting genetic material specific to chlamydia and gonorrhea present in the test
specimen. This technique is used for Gen-Probe PACE2 testing and was employed by
the laboratories participating in this study.


99
Inclusion and exclusion criteria
For the preliminary descriptive analyses all records in each relational database table
were included to determine the sample distribution. These records include: the birth fetal
death records, STD case morbidity for mothers and infants, the Healthy Start prenatal
screening records, the laboratory test database for mothers and infants, and the congenital
syphilis case reports. At the second step, descriptive analyses were conducted on the final
linked study sample. The study sample was limited to all women and female adolescents
who initiated prenatal care through county health departments and met the following
inclusion criteria: pregnant, with a social security number and date of birth, and a matching
birth fetal death record registered in the Florida Vital Statistics for 1996. The sub
populations of women and adolescents who delivered low birth weight, term low birth
weight, and pre-term low birth weight infants were then examined for distribution,
similarities, and differences and compared to similar sub-populations in the full birth and
fetal death records file.
Exclusion criteria were applied only to the extracted study sample. The study
sample was extracted with the following exclusion parameters: 1) non-county health
department client as identified from the Healthy Start data file variable CHD provider;
2) multiple-gestation births; and 3) those births identified as delivered by Cesarean section.
(Keith, Papiemik, Keith,, & Luke, 1995; Ventura, Martin, Mathews,, & Clarke, 1996).
The exclusion criteria decision for each relate to the scope of the study question(s). The
investigator sought to examine women served in county health departments with a
chlamydia test result. No laboratory information is available within the linked database for
the majority of women, those served by private providers.


87
Alcohol use in pregnancy was obtained from a field on the live birth certificate.
When yes is answered, a secondary part asks for the average number of drinks per week.
This variable does not allow for identification of when, during the pregnancy, alcohol was
consumed, or if the woman drank and then stopped drinking once she realized she was
pregnant.
Alcohol use in the last two months was obtained from a field on the Healthy Start
prenatal screen. This variable does not allow for clarification if the consumption took
place prior to the onset of pregnancy, as might be the situation where a screen was
conducted early in the first trimester. When considered alone, the information from this
variable does not provide clear information on the quantity of alcohol consumed, or
whether the woman drank throughout the pregnancy. Both of these variables are a crude
measure of alcohol use in pregnancy and do not provide an accurate level of risk
assessment or measurement.
Birth interval was created to capture information on the time from any prior event
of pregnancy regardless of outcome, and the present birth. Many authorities have long
espoused that a woman should ideally space births two years apart to allow their bodies to
replace reserves and recover physiologically from the pregnancy and birth processes
(Youngkin & Davis, 1994). Researchers in Utah recently defined a short inter pregnancy
interval (IPI) as one that was less than 12 months based on a parallel study that
demonstrated an increased association for adverse perinatal outcomes with IPIs of less
than 12 months (Duncan, Nagle, Streeter, Bloemaum, & Tingey, 1998). This group
calculated the DPI from the time between delivery dates of consecutive live-bom infants
and the gestational age of the most recent child. Another study conducted in Florida


This study is dedicated to my parents John and Ardelle Schmitt. Their life has long
been an example of hard work, love and commitment to each other, their children and
grand children. They have always provided generous support to the dreams we each have
had and more importantly never doubted our ability to achieve them. They will always
remain a powerful influence and beacon light for the path ahead, and for each of
my tomorrows.


2
5.5% in those aged 20-24 years. The rates were lower among women more than 24 years
old (Schmitt, 1996a).
Close to 80% of infected females and more than 65% of infected males are
asymptomatic (Gaydos et al., 1998; Quinn et al, 1996; Schmitt, 1996b, 1999). Hence the
potential exists for undetected and untreated infections, or inadequately treated
chlamydial infections to lead to significant morbidity, with an increased risk of
postpartum endometritis, ectopic pregnancy, pelvic inflammatory disease, salpingitis,
preventable infertility, chronic pain syndromes, septic disseminated infection,
spontaneous abortion, pre-term labor, or even death. In the infected neonate chlamydial
infections are associated with pneumonia, otitis media, and conjunctivitis (Batteiger,
Fraiz, Newhall, Katz, & Jones, 1989; Brunham, Holmes, & Embree, 1990; CDC, 1998b;
Berman et aL, 1987; Askienazy-Elbhar, 1996; Gene & Mardh, 1996; Harrison &
Alexander, 1990; National Academy of Sciences, 1996; Gencay et aL, 1995; Datta et aL,
1988). Chlamydia trachomatis has also been associated with adult and childhood
myocarditis and atherosclerosis (Muhlestein et aL, 1996; Grayston, Mordhorst, & Wang,
1981). Pathologic synergism has been identified between chlamydia and cervical
dysplasia (Paavonen, Koutsky, & Kiviat, 1990; Yla-Outinen et aL, 1990). Chlamydia has
also been shown to enhance transmission of human immunodeficiency virus infection by
three to four fold (Laga et aL, 1993; Plummer et aL, 1991).
During the last decade there has been an increased awareness of chlamydial
infections and reporting of most identified cases of chlamydia (CDC, 1995, 1996b,
1998b). The epidemiology of Chlamydia trachomatis during pregnancy suggests a range
of prevalence from less than 6% to over 20%, depending on the age, clinic setting and


216
Appendix A. Continued.
Original Variable
Name
New Variable
Name
Variable labels
DEXMOM
DEXMOM
day of exam
YTXMOM
YTXMOM
year of treatment
MTXMOM
MTXMOM
month of treatment
DTXMOM
DTXMOM
day of treatment
V231
V231
treatment
BFD F
BFD F
b or fd designation for mom case morbidity
V233
V233~
certificate number mom case morbidity
V234
V234
bfd number mom case morbidity
V235
V235
morbidity file age group


202
O Campo, P., Xue, X., Wang, M., & Caughy, M. (1997). Neighborhood risk factors for
low birthweight in Baltimore: A multilevel analysis. American Journal of Public
Heal^87(7), 1113-1118.
Oh, M. K., Cloud, G. A., Fleenor, M, Sturdevant, M. S., Nesmith, D., & Feinstein, R. A
(1996). Risk for gonococcal and chlamydial cervicitis in adolescent females:
Incidence and recurrence in a prospective cohort study. Journal Adolescent Health
Care. 18(41. 270-275.
Olsen, J. (1992). Cigarette smoking in pregnancy and fetal growth: Does the type of
tobacco play a role? International Journal of Epidemiology. 21. 279-284.
Orr, S. T., James, S. A, Miller, C. A., & Barakat, B. (1996). Psychosocial stressors and
low birthweight in an urban population. American Journal of Preventive Medicine.
12(6), 459-466.
Oshiro, B. T., Graham, J. M., Blanco, J. D., Seraj, I. M., & Bishop, K. D. (1994).
Pregnancy outcome in swiss-webster mice infected with Chlamydia trachomatis.
Infectious Disease in Obstetrics and Gynecology. 1(5). 242-245.
Paavonen, J., Kiviat, N., Brunham, R. C., Stevens, C. E., Kuo, C. C., Stamm, W. E.,
Meittinen, A, Soules, M., Eschenbach, D. A, & Holmes, K. K. (1985).
Prevalence and manifestations of endometritis among women with cervicitis.
American Journal of Obstetrics and Gynecology. 152. 280-286.
Pachciarz, J. A., Abbott, M. L, Gorman, B., Henneman, C. E., & Kuhl, M. (1992).
Continous quality improvement of pap smears in an ambulatory care facility.
Quality Review Bulletin. 7. 229-235.
Papiemik, E., Charlemain, C., Goffinet, F., Paul, G, & Keith, L. G. (1998). Vaginal
bacterial colonization, the uterine cervix and preterm births. Prenatal and Neonatal
Medicine. 3(11. 98-102.
Pate, M. S., Dixon, P. B., Hardy, K., Crosby, M., & Hook. E. W. (1998). Evaluation of
the biostar chlamydia oia assay with specimens from women attending sexually
transmitted disease clinic. Journal of Clinical Microbiology. 36(81. 2183-2186.
Patient Outcomes Research Team. (1998). Low birthweipht in minority and high-risk
women. Washington, DC: Agency for Health Care Policy and Research.
Patton, D. L., Askienazy-EIbhar, M., Henry-Suchet, J., Campbell, L. A., Cappuccio, A.,
Tannous, W., Wang, S-P., & Kuo, C-C. (1994). Detection of Chlamydia
trachomatis in fallopian tube tissue in women with postinfectious tubal infertility.
American Journal of Obstetrics and Gynecology, 171. 95-101.


59
the development of pre-eclampsia during their own pregnancies as teenagers or young
adults (Innes, Marshall, Byers, & Calonge, 1999).
Contribution of sexually transmitted infections Dunkel-Schetter (1998) has
suggested the possibility that stress increases risky sexual behavior during pregnancy, with
reduced prenatal care utilization for the detection of infection. However, she offers no
evidence to support this concept. Other literature reports ample associations between intra
and inter-uterine infection, low birth weight, spontaneous pre-term labor/delivery and the
more commonly known sexually transmitted infections like gonorrhea, syphilis, herpes,
trichomonas, and more recently, chlamydia and human immunodeficiency virus. Less
commonly known are other diseases often associated with sexually active women, but
whose modes of transmission are even less well understood than the historical STDs.
These include group B Streptococcus, hepatitis B and C, cytomegalovirus, and the many
organisms associated with bacterial vaginosis. The more well known adverse pregnancy
events associated with STDs include stillbirth, perinatal death, and mental retardation,
attributable to early syphilis, herpes, cystomegalovirus, and group B Streptococcus,
(Goldenberg, Andrews, Yuan, Mackay, & St, Louis, 1999).
Eschenbach (1998) suggests that any amniotic infection is a fetal infection, and
consequently may have a role in causality of pre-term delivery before 28 weeks. Other
recent studies with chlamydia that have examined pathogenesis of the fetal, and maternal
tissues would support such a hypothesis and deserve more consideration.
Not much research has been conducted to examine the direct association between
low birth weight and each sexually transmitted infection while controlling for other
confounding variables. Researchers have prospectively evaluated the role of Trichomonas


113
Table 6. Continued.
Births
Fetal Deaths
TOTALS
Relational Database
190,497
1.501
191,998
Study Sample
13,914
88
14,002
#
%
#
%
Trimester of entry1
Is4
116,328
43.1
8,602
61.4
2nd
51,099
20.2
4,351
31.1
3rd
12,189
4.8
1,012
7.2
Method of delivery
Vaginal
149,304
77.8
-
-
Cesearean section
41,949
21.9
-
-
Is* pregnancy yes
62,314
24.1
5,204
37.2
Mother Hispanic yes
36,001
18.8
3,039
21.7
Mother foreign born yes
46,422
24.2
3,392
24.2
Mothers race
Black
42,906
22.3
4,217
30.1
Other
4,652
2.4
293
2.1
White
144,197
75.0
9,492
67.8
Infants race
Black
45,935
23.9
4,556
32.5
Other
5,499
2.9
335
2.4
White
140,341
73.1
9,111
65.1
1 Represents the Heahhy Start variable.
While more than two thirds of women statewide were married at the time of
delivery, a little more than one third in the sample were married. More than twice as many
mothers had not yet finished high school in the sample while a similar distribution was


159
was observed statewide among women who received their prenatal care at the county
health departments during the same time period (2.0%, 5.5%).
Key among the independent variables at the bivariate level, was the significant
association between many of them and low birth weight. The study question variable,
chlamydia infection, was significant at all levels of low birth weight, indicating nearly two
fold the risk of low birth weight among, infected pregnant women; unadjusted odds ratios
at the 95% confidence interval were 1.88, 1.87 and 1.86 with p values 0.00, 0.03, and
0.01, respectively. Other traditionally reported risk factors such as smoking, inadequate
weight gain, black race, and history prior poor birth outcomes, were also significant. Of
interest was the protective association of stress and of not having completed high school.
Noteworthy, was the statistical significance of gonorrheal infection and the pooled
infection of other sexually transmitted infections; these were higher than smoking,
chlamydia, and race.
An unanticipated finding for this researcher was the persistent and very significant
association between inadequate weight gain and low birth weight. This association
remained in each of the first four logistic models and across all ranges of low birth weight.
The adjusted odds ratios at 95% confidence interval ranged from a low of 2.27 (p <
0.0000) among women of black race/ethnicity with low birth weight to a high of 3.75 (p
< 0.0000) among women of white race/ethnicity who delivered a pre-term low birth
weight infant. The highest significance within each of the four models was with pre-term
low birth weight. Most other studies examining the association between weight gain and
pre-term delivery have identified an increased risk ranging from 50% to 100% among
pregnant women with inadequate weight gain (Carmichael & Abrams, 1997). Overall, the


90
Medical history for this pregnancy is a category reported on the birth record to
capture any of the following sub-variables; diabetes, chronic hypertension, anemia
(hemoglobin <10, hematocrit < 30), pregnancy-associated hypertension, cardiac disease,
hydraminos, oligohydraminos, eclampsia, renal disease, acute or chronic hmg disease, or
hemoglobinopathy. Extensive literature exists linking these sub-variables with adverse
pregnancy and birth outcomes. Isolation and linkage of each of these sub-variables was
beyond the scope of this study. There is less or significantly conflicting information for
other sub-variables such as like genital herpes, incompetent cervix, Rh sensitization and
other/specified
Mistimed pregnancy Three fields on the Healthy Start prenatal screen file contain
information on the timing of this pregnancy in response to the question Tf you could
change the timing of this pregnancy, would you want it a) earlier, b) later, c) not at all, or
d) no change? An answer of yes to any of the first three fields designated a woman as at
risk for a mistimed pregnancy in the indicator variable. Mistimed or unwanted pregnancies
have been associated with increased risk of LBW and pre-maturity (Committee on
Unintended Pregnancy, 1995). This group examined numerous studies and reported
unadjusted odds ratios ranging from 1.2 to 1.4. The authors noted that if all unwanted
pregnancies were eliminated there would be 7% less births, less than 2,500 grams among
black women and 4% less among white women (Kendrick, 1990 as cited in Committee on
Unintended Pregnancy, 1995). An evaluation of various population based surveys
conducted in Florida suggests that the unintended pregnancy rate ranged from 43.04 % to
61.92% during 1993 among the women surveyed (Steele, 1995).


227
/ORDER ANALYSIS .
To create inadequate weight gain indicator.
compute LAWGindi=0.
if ((BMIG eq 1) and (gweeks ge 37) and ( wtgain LT 28)) IAWGindi=l.
if ((BMIG eq 2) and (gweeks ge 37) and (wtgain LT 25 )) IAWGindi=l.
if ((BMIG eq 3) and (gweeks ge 37) and (wtgain LT 15 )) IAWGindi=l.
if ((BMIG eq 4) and (gweeks ge 37) and (wtgain LT 15 )) IAWGindi=l.
if ((BMIG eq 1) and (gweeks ge 20 and gweeks le 36) and (wtgain LT (12 + (gweeks-
20)))) IAWGmdi=l.
if ((BMIG eq 2) and (gweeks ge 20 and gweeks le 36) and (wtgain LT (10.5 + (gweeks-
20)))) IAWGindi=l.
if ((BMIG eq 3) and (gweeks ge 20 and gweeks le 36) and (wtgain LT (7.25 + (gweeks-
20)))) IAWGindi=l.
if ((BMIG eq 4) and (gweeks ge 20 and gweeks le 36) and (wtgain LT (7.25 + (gweeks-
20)))) IAWGindi=l.
missing values IAWGindi (-1).
FORMATS IAWGindi (F8).
VARIABLE LABELS IAWGindi "inadequate weight gain indicator".
VALUE LABELS IAWGindi
.000000000000000 "adequate weight gain"
1.00000000000000 "inadequate weight gain"
FREQUENCIES
VARIABLES= IAWGindi
/ORDER ANALYSIS.
To create a CT and GC infected indicators for mom and infant.
compute CTindic=0.
if (CTRESULM = 1) CTindic=l.
if (CTRESULM = 3 or CTRESULM = 4) CTindic=-l.
missing values CTindic (-1).
FORMATS CTindic (F8).
VARIABLE LABELS CTindic "CT infected mom".
VALUE LABELS CTindic
.000000000000000 "CT negative"
1.00000000000000 "CT positive"
compute GCindic=0.
if (GCRESULM = 1) GCindic=l.
if (GCRESULM = 3 or GCRESULM = 4) GCindic=-l.
missing values GCindic (-1).
FORMATS GCindic (F8).
VARIABLE LABELS GCindic "GC infected mom".
VALUE LABELS GCindic


148
OR 1.96, a history of a prior poor pregnancy
OR 1.76, use of any form of tobacco in the two months prior to HS screen
OR 1.51, mother was of black race
OR 1.37, mother not married
Logistic Model Five: All CHD with race indicator and inadequate weight gain -
term low birth weight. This sub-sample examined women identified with inadequate
weight gain, controlling for those who did gain the recommended amount for their body
mass index and length of gestation and who delivered a term low birth weight infant. The
analysis terminated after the 13th step and included 2,864 excluding the 236 for missing
data. (Please refer to Table 18.)
No STD related predictor variable was significantly associated with term low birth
weight. The chlamydial indicator was removed at the 3rd step; the gonorrheal indicator was
eliminated at the 6th step and the STD indicator at the 12th step. The following
independent variables were identified as significant:
OR 3.62, use of alcohol at any time during pregnancy
OR 2.93, mother weighed less than 5.5 pounds when she was bom
OR 2.35, identified as having smoked at any time dining pregnancy
OR 2.19, a history of a prior poor pregnancy
OR 1.75, pregnancy was mistimed
OR 1.61, mother was of black race
Not having completed high school and a history of a medical condition during the
pregnancy both reduced the likelihood of a term low birth weight event by 40% and 50%
respectively.


144
Logistic model four: Women of black race only TLBW. Due to missing data on
284 of the 4,217 women in the study sample, 3,933 cases were included in this analysis
and terminated after the 13th step. The gonorrheal and chlamydial infection indicators were
eliminated at the 7th and 9th steps due to low significance. Overall most variables had a
higher odds ratio than in other sub-samples. Again mother not being a high school
graduate decreased her risk of experiencing a PTLBW event by 43%. (Please refer to
Table 17.)
OR 2.46, mother had inadequate weight gain
OR 2.43, identified as having smoked at any time during pregnancy
OR 2.39, use of alcohol at any time during pregnancy
OR 2.24, a history of any sexually transmitted infections
OR 2.18, mother weighed less than 5.5 pounds when die was bom
OR 2.10, a history of a prior poor pregnancy outcome
OR 0.57, mother not a high school graduate
Logistic model four: Women of black race only PT .RW Due to missing data on
210 of the 4,217 black women in the study sample, 4,007 cases were included in this
analysis. The analysis was terminated after the 15* step. The gonorrheal and chlamydial
infection indicators were eliminated at the 4th and 9th steps due to low significance. As in
the other models for this sub-sample, a history of any sexually transmitted infection
remained significantly associated with an increased risk of PTLBW. Two variables were
again protective: lack of a high school diploma and mother bom outside of this country.
(Please refer to Table 17.)


130
Table 13. 1996 Statewide Chlamydia and Gonorrhea Prevalence Estimates Based on
Laboratory Test Results.
Chlamydia +
Gonorrhea +
Dual
Infected
# of records
%
#
%
it
%
#
Total
128,786
4.7
6,106
4.4
5,690
0.6
795
Age Category
< 15 years
1,261
9.6
121
4.2
53
1.6
20
15 19 years
27,219
9.3
2,530
5.3
1,430
1.4
382
20 24 years
35,490
6.1
2,176
4.7
1,689
0.7
254
25 29 years
23,973
3.0
735
3.7
893
0.3
76
30 -34 years
16,834
1.8
296
3.6
613
0.2
33
35 39 years
11,226
1.1
127
4.1
465
0.1
15
40-44 years
5,895
0.7
43
4.7
274
0.1
5
> 45 years
6,119
0.6
39
3.8
234
0.1
7
Race/ethnicity
Black
48,748
7.5
3,666
9.6
4,436
1.3
637
Hispanic
1,920
4.6
92
2.4
46
0.2
4
Other
1,293
4.2
54
2.3
20
0.3
46
White
72,605
3.0
2,139
1.2
859
0.2
141
Unknown
1,917
4.3
81
1.8
33
0.2
Gender
Female
107,222
4.2
4.2
1.8
1.928
0.5
553
Male
21,615
7.3
7.3
17.3
4,849
1.1
236
Unknown
1,917
5.1
5.1
2.5
4
-
-
Program code
Family Planning
52,096
3.6
1,852
0.9
462
0.3
158
HIV Clinic
189
1.1
2
4.8
9
-

Other
6,819
2.2
150
1.4
96
0.2
16
Pre Natal
14,655
5.5
796
1.1
153
0.5
72
STD Clinic
28,966
6.5
1,856
11.1
3,169
1.1
312
Unknown
27,126
5.4
1,450
6.7
1,801
0.9
237
Content adapted from: Schmitt, 1996a.


APPENDIX A
VARIABLE LIST


CHLAMYDIAL INFECTION IN PREGNANCY:
AN ASSOCIATION WITH LOW BIRTH WEIGHT
By
KARLA SCHMITT
A DISSERTATION PRESENTED TO THE GRADUATE SCHOOL
OF THE UNIVERSITY OF FLORIDA IN PARTIAL FULFILLMENT
OF THE REQUIREMENTS FOR THE DEGREE OF
DOCTOR OF PHILOSOPHY
UNIVERSITY OF FLORIDA
1999


65
Protection nf Human Subjects
"'This was a retrospective epidemiologic analysis of existing data. The University of
Florida, Health Center Institutional Review Board, and the Florida Department of Health,
Review Council for Human Subjects, both approved the study protocol. The request to
waive documentation of informed consent was approved by both groups. No direct
contact was made with subjects. No treatment or care was provided or altered for the
subjects included in this study. Since this study retrospectively examined existing
information, no individual informed consents were deemed necessary by either review
body. The reporting of births and fetal deaths and of positive tests diagnostic of the
sexually transmitted infections studied and morbidity information is required by law;
Chapters 382 and 384, Florida Statutes. The original consents to examine the data sets as
outlined in the study protocol were obtained from the respective administrative data
managers charged with the confidential maintenance of each data systems that contained
the morbidity or vital records. Oversight review for the study was provided by Department
of Health Review Council for Human Subjects.
Confidentiality
During the entire duration of the research period, the confidentiality of all data
systems was maintained in compliance with confidential security management protocols of
the Florida Department of Health. The study data set was stored on a server with access
limited to the investigator and four other departmental staff who assisted with the data
extraction process. The final study data set constructed through the matching process was
password protected and accessible only to the investigator. The researcher was assisted by


200
Moore, D. E., & Cates, W. (1990). Sexually transmitted diseases and infertility. In K.K.
Holmes, P. A. Mardh, P. F. Sparling, & P. J. Wiesner, (Eds.), Sexually transmitted
diseases (pp. 763-769). New York, NY: McGraw-Hill, Inc.
Morrison, R_ P. (1996). Immune protection against Chlamydia trachomatis in females.
Infectious Diseases in Obstetrics and Gynecology, 4. 163-170.
Morrison, R. P., Lyng, K., & Caldwell, FL D. (1989). Chlamydial disease pathogenesis -
ocular hypersensitivity elicited by a genus-specific 57 kDa protein. Journal of
Exploratory Medicine. 169. 663-675.
Morre, S. A., Moes, R. M., Van Vaalkengoed, I. G. M., Boeke, J. A. P., Meijer, C. J. L.
M., & Van den Brule, A. J. C. (1998). Chlamydia trachomatis genotyping in urine
specimens will faciltate large epidemiological studies. [Abstract}. In R. S.
Stephens, G. L Byrne, G. Christiansen, I. N. Clarke, J. T. Grayston, R. G. Rank,
G. L. Ridgeway, P. Saikku, J. Schachter & W. E. Stamm (Eds.), Chlamydial
Infections Proceeding of the Ninth International Symposium on Human
Chlamydial infection (pp. 63-66). San Francisco, CA: Author.
Morse, S. A, & Beck-Sague, C. M. (1999). Gonorrhea. In P. J. Hitchcock, FL T. MacKay
& J. N. Wasserheit (Eds.), Sexually transmitted diseases and adverse outcomes of
pregnancy (pp. 151-174). Washington, DC: American Society for Microbiology.
Much, D. FL, & Yeh, S. (1991). Prevalence of Chlamydia trachomatis infection in
pregnant patients. Public Health Reports. 106(5). 490-493.
Muhlestein, J. B., Hammond, E. H., Carlquist, J. F., Radicke, E., Thomson, M. J.,
Karagounis, L A, Woods, M. L., & Anderson, J. L. (1996). Increased incidence of
Chlamydia species within the coronary arteries of patients with symptomatic
atherosclerotic versus other forms of cardiovascular disease. Journal of American
College of Cardiologv27(71; 1555-1561.
Nair, P., Alger, L., Hines, S., Seiden, S., Hebei, R_, & Johnson, J. P. (1993). Maternal and
neonatal characteristics associated with HIV infection in infants of seropositive
women. Journal of Acquired immune Peficincv Syndromes. 6. 298-302.
Nathan, L., Bawdon, R. E., Siwadi, E., Stettler, R. W., Mclntire, D. M., & Wendel, G. D.
(1993). Penicillin levels following the administration of benzathine penicillin G in
pregnancy. Obstetrics and Gynecology, 82. 338-342.
National Academy of Sciences. (1996). The hidden epidemic: Confronting sexually
transmitted diseases (pp. 305-309). Washington, DC: Institute of Medicine.
National Chlamydia Committee. (1999a). Persistence of chlamydial DNA and chlamydial
antigens after therapy. Paper submitted for review.


154
late latent. A diagnosis of early latent syphilis is based on or more of the following criteria:
1) documented seroconversion or fourfold or greater increase in titer of a nontreponemal
test during the previous 12 months; 2) a history of symptoms consistent with primary or
secondary syphilis during the previous 12 months; 3) history of sexual exposure to a
confirmed or probable primary or secondary case; and 4) reactive nontreponemal test and
treponemal tests from a person whose only possible exposure occurred within the
preceding 12 months (CDC, 1997b). While the numbers of linked STD cases in the study
file are much fewer than those in the larger relational database, and it is of limited value to
conclude anything from the results, the trends are the same. These include: 1) not all
congenital syphilis cases were linked with a woman also identified as having syphilis from
the case morbidity file and 2) not all cases of chlamydia pneumonia or opthalmia were
linked to a woman who was identified as having the infection either on the case morbidity
file or from laboratory tests. Five of those in the study sample with latent syphilis were
low birth weight.
Among all women in the relational database identified with syphilis during the time
parameters as appropriate to her individual pregnancy, 20% (5/24) of those with primary
or secondary syphilis had a low birth weight event compared to 11% (30/261) with latent
syphilis. Of the nine syphilis and fetal death linked records, none were low birth weight.
Closer scrutiny of the syphilis cases in the database revealed that 14% received
treatment outside of the standard parameter of 14 days from diagnosis, and 17% never
received appropriate treatment for the stage of disease. The majority of all these cases
were not reported into the case morbidity system within the standard of 14 days from test
date to report date.


112
Table 6. Comparison of Select Demographic Variables Between Relational Database and
Study Sample.
Births
Fetal Deaths
TOTALS
Relational Database
190,497
1.501
191,998
Study Sample
13,914
88
14,002
#
%
#
%
Age at delivery
<14
634
0.3
129
0.9
15-17
9,459
4.9
1,708
12.2
18-19
15,279
8.0
2,408
17.2
15-19
24,738
12.9
4,116
29.4
20-24
46,454
24.2
5,008
35.8
25-29
50,973
26.5
2,633
18.8
30-34
44,089
23.0
1,399
10.0
35-39
20,639
10.7
590
4.2
>40
4,288
2.2
127
0.9
Educational level
< High school
40,906
21.6
6,287
44.9
High school
67,274
35.0
5,333
38.1
> High school
82,180
42.8
2,213
15.8
Married yes
124,314
67.7
5,506
39.3
Prenatal Provider
CHD
17,162
8.9
14,002
100
DOH contract
9,119
4.7
n/a
n/a
Private
46,689
24.3
n/a
n/a
Insurance
HMO
23,993
12.5
356
2.5
Medicaid
43,450
22.6
9,684
69.2
Other
4,424
2.3
123
0.9
None
18,315
9.5
3,807
27.2


230
To create a variable for all weeks from 1 to 42.
(less the really extreme outliers
compute allGwks=trunc((CDOBdays-LMPdays)/7).
if (allGwks GT 42 or allGwks LT 1) allGwks=-l.
if (LMPM GT 12 or LMPM LT 1) allGwks=-l.
if (CDOBM GT 12 or CDOBM LT 1) allGwks 1.
missing values allGwks (-1).
execute.
FORMATS allGwks (F8).
VARIABLE LABELS allGwks "42 gestational wks".
FREQUENCIES
VARIABLE S=allGwks
/HISTOGRAM NORMAL
/ORDER ANALYSIS .
To create a foriegn bom indicators for mom and dad.
compute momforgn=0.
if (MBST ge 52 and MBST le 59) momforgn=l.
if(MBST ge 88) momforgn1.
missing values momforgnT (-1).
execute.
FORMATS momforgn (F8).
VARIABLE LABELS momforgn "mom foreign bom".
VALUE LABELS momforgn
.000000000000000 "US bom
1.00000000000000 "foreign bom".
compute dadforgn=0.
if (FBST ge 52 and FBST le 59) dadforgn=l.
if(FBST ge 88) dadforgn 1.
missing values dadforgn(-l).
execute.
FORMATS dadforgn (F8).
VARIABLE LABELS dadforgn "dad foreign bom".
VALUE LABELS dadforgn
.000000000000000 "US bom"
1.00000000000000 "foreign bom".
FREQUENCIES
VARIABLES= momforgn dadforgn
/ORDER ANALYSIS .


83
Definition of Study and Indicator Variables
The study variables used by this investigator were obtained from different data sets
within the linked relational database. Dependent variables and independent indicator
variables were created to support the calculation of crude odds ratios and the logistic
regression analyses. Please see Table 3.
The list includes the following: alcohol use in pregnancy, alcohol use in the last
two months, birth interval, body mass index group, chlamydia positive, gonorrhea
positive, gestational age, high school graduate, history of past or current sexually
transmitted disease, inadequate weight gain, low birth weight group by gestation, low
birth weight, marital status, medical history, mistimed pregnancy, mother was low birth
weight at birth, mother is of foreign birth, mother of black race, mother resides in a rural
area, prenatal care indices, prior poor pregnancy outcome, smoked during pregnancy,
smoked in the last two months, and stress identified in mother's life. All indicator variables
used in logistic regression were coded with O for absence o£ and 1 for the presence of
the designated condition, risk or measure. Other variables were coded according to their
use in the study analysis. Supportive syntax utilized for the indicator variables is contained
in Appendix B. The dependent variables included low birth weight and low birth weight
groups by gestational age. All other variables were used as independent variables in the
calculation of crude odds ratios and for the logistic regression models. Due to the
complexity of some variables, and their development from multiple database variables,
more in-depth explanation follows.


81
database with its stand-alone design was the failure to directly link by computer the infant
case congenital records to the maternal case history, laboratory tests, or treatment records.
This weakness has been resolved in the 1998 STD*MIS system version with the
development of an internal congenital syphilis module.
Methodological issues in the use of administrative databases
Teutsch and Churchill (1994) make recommendations regarding the management
of databases to maintain the integrity and completeness. Among the issues that must be
addressed are the credentials of data entry staff, updating of records, back-up of computer
files, automatic data entry fields, e.g., todays date or todays age calculated from date of
birth. Controlled system parameters and must enter fields are useful to ensure accurate
spelling of common variables, e.g., county names, and validate data entry for
completeness. No documented independent validation studies have been conducted on the
data contained in any of these data systems and entered during the period spanning late
1995 to the middle of 1997, the timeframes for data-sets included in the study. However,
routine production of quality assurance reports facilitate the identification and frequency
of common errors, identify the appropriateness of the range of values entered, and assess
the completeness of demographic data entry from each of the systems from which these
data set were extracted.
Other published guidelines provide suggestions for the evaluation of surveillance
systems like the STD maternal and infant case morbidity and congenital systems used in
this study. Evaluation of a surveillance systems should include 1) description of the
importance of the health event under surveillance, 2) description of the system, 3)


CHAPTER 2
REVIEW OF THE LITERATURE
The specific aim of this chapter is to review the literature relevant to the research
question. This chapter will consist of eight sections. The epidemiology, biology, and
pathogenesis of Chlamydia trachomatis will be reviewed. The epidemiology of low birth
weight and common risk factors for low birth weight will be covered in other sections.
Finally laboratory diagnosis of chlamydial infections, confounding factors related to
specimen collection, testing standards for the specific test used in this study, and the
sensitivity and specificity of tests available for the detection of Chlamydia trachomatis will
be discussed.
Epidemiology and Prevalence of Chlamydia trachomatis
Infection in the female reproductive tract (especially in the cervix) can cause
premature rupture of membranes and induce premature labor [and] this is responsible for
many preventable infant deaths, 1950 quote attributable to L C. Knox and J. K. Homer
(McGregor & French, 1997).
Chlamydia trachomatis has led the list of nationally reportable diseases since 1995.
Chlamydia and other sexually transmitted diseases such as gonorrhea, AIDS, primary and
secondary syphilis, and hepatitis B accounted for 87% of the top ten most frequently
9


174
that would appropriately address eating behaviors, eating disorders, access to the needed
food groups, and instruction on preparation of nutritionally valuable meals.
implications for Public Health Policy
A relational database of the size developed for this study is a labor-intensive
initiative. It is also a powerful tool for examination of numerous public health issues and
problems from the vantage of different program priorities. It would be advantageous for
the Florida Department of Health to assure that common demographic information
contained in the many data systems used in this study be standardized, in the future, to
support more relational database analyses. This will entail simultaneous development of
coding, file layout for the fields and conversion programming to support the transmission
of data files to different federal agencies, e.g., National Center for Health Statistics, The
Centers for Disease Control and Prevention. These same federal agencies also do not
share standard coding of variables such as race, ethnicity or counties between offices
within their own agency or with other federal agencies involved in the collection of health
related data.
Future computerized data systems should be developed with all the input of all
parties that might want to utilize the data. While data systems are developed to support
particular program goals, statutory requirements, or the evaluation of services, the
involvement of prospective users of the data could greatly enhance the benefits to program
goals, evaluation and reduce costs in recognition of unproductive services through better
analyses. A Department of Health-wide ongoing cross-disciplinary work group focused on


40
decreases in sensitivity a significant cost savings of 37% to 46% with pooled sensitivity of
92.8% in pools of four urines and 97.9% in pools of 8 urines (Krepel et aL, 1999). Gaydos
and colleagues (1998) reported lower sensitivity (88.6%) using amplified testing on urine
specimens. Unfortunately, amplified tests remain much more costly than other direct
detection methods. Direct detection offers the advantage of rapid results when compared
to cultivation in culture mediums. Other advantages are generally affordable cost and high
volume capabilities, important considerations for any public health screening program. The
disadvantage of the direct detection approach is variable sensitivity and specificity between
testing technologies and manufactured products, as well as variable sensitivity and
specificity among groups with different prevalence, a phenomenon common to all
screening tests.
Cultivation of the organism in a suitable host is the standard by which all other
detection methods are compared, especially for medical-legal documentation. This is true
for Chlamydia trachomatis, even though cell culture is reported to range from 50% to
90% sensitive (Fedorko & Smith, 1991; Newhall et aL, 1999). The range of sensitivity is a
function of prevalence in the population, laboratory expertise, quality of specimen
collection and most often, of specimen transportation. Specimens collected to identify
Chlamydia trachomatis must be inoculated onto cycloheximide-treated McCoy cells. The
specimens should be refrigerated and processed within 48 hours of collection; if the
interval will be longer then the specimens should be frozen at 60 C (Schachter, 1995).
These parameters and the bacterias sensitivity to heat exposure often adversely effect the
viability of organisms for cell culture during the transportation interval These factors


60
vaginalis in low birth weight in a large multi-center study among an ethnically diverse
population (Cotch et aL, 1991, 1997). They reported at a 95% confidence interval that
pregnant women infected with the protozoan were significantly more likely to deliver a
low birth weight infant, and to have a pre-term birth weight infant (OR 1.3, and 1.4, p <
.01). Also, infection with Trichomonas vaginalis accounted for a disproportionate share
of low birth weight deliveries among blacks as compared to whites or Hispanics in this
study. Earlier studies found no association between the pathogen and low birth weight
(Mason & Brown, 1980; Ross & Middlekoop, 1983, as cited in Wohier-Hanssen, 1999).
Trichomonas vaginalis is more likely to be found in the squamous epithelium, but
evidence has been reported of infection in desquamated cells from human amniotic
membranes (Wolner-Hanssen, 1999).
Syphilis was the earliest recognized maternal sexually transmitted infection to be
associated with adverse outcomes. One study published in 1917 and another in 1951
identified a transmission rate during pregnancy of 60% to 70% (Schultz, Schulte, &
Berman, 1992). While sexual transmission is believed to cease after four years of infection,
the possibility of transmission of the spirochete to the fetus by blood-bome transplacental
infection is more enduring as demonstrated with a 25% risk of fetal infection during early
and 12% during late syphilis (Ingraham, 1951, as cited in Radolf, Sanchez, Schulz, &
Murphy, 1999). Many studies have identified the strong association between stillbirth and
spontaneous abortion,the most common sequelae, that occurs most often in the 2nd and
early 3rd trimesters (Radolf Sanchez, Schulz, & Murphy, 1999). No literature is available
that suggest an association between syphilis and low birth weight while controlling for
other confounding variables.


126
The strongest indicator in all low birth weight events was an inadequate weight
gain: OR of 3.12 for LBW, OR 2.56 for TLBW, and 3.35 with PTLBW. (Please refer to
Tables 10-12.) Examination of inadequate weight gain between women of different
race/ethnicity groups indicates that both white and black women were 20% more likely to
have inadequate weight gain with short inter pregnancy intervals. For both white and black
Table 11. Unadjusted Odds Ratios for Term Low Birth Weight, Based on Bi-variate
Analysis of Independent Variables in the Study Sample.
Variable
OR
95% Cl
p value
1. Age < 18, > 40
1.32
1.00, 1.75
0.0491
2. Alcohol use from birth record
4.17
2.42, 7.17
0.0000
3. Alcohol use from Healthy Start screen
1.69
1.31,2.20
0.0001
4. Birth interval short
0.80
0.61, 1.06
0.1173
5. Chlamydia positive
1.87
1.06, 3.30
0.0305
6. High school no-
0.94
0.75, 1.18
0.6023
7. Gonorrhea positive
4.23
1.67, 10.70
0.0024
8. Inadequate PNC indices
1.40
1.13, 1.74
0.0021
9. Inadequate weight gain
2.56
2.06, 3.17
0.0000
10. Married-not
1.38
1.10, 1.73
0.0048
11. Medical history
1.05
0.74, 1.49
0.7899
12. Mistimed pregnancy
1.19
0.96, 1.47
0.1121
13. Mom foreign bom
0.75
0.57, 0.97
0.0298
14. Mom LBW
1.95
1.47, 2.58
0.0000
15. Prior poor pregnancy outcome
1.84
1.46, 2.31
0.0000
16. Race of mother black
1.70
1.38, 2.11
0.0000
17. Rural residence
0.93
0.75, 1.16
0.5399
18. Smoking from birth record
2.05
1.64, 2.56
0.0000
19. Smoking from Healthy Start
1.49
1.20, 1.85
0.0003
20. STDs, past or current
2.08
1.26, 3.42
0.0042
21. Stressful life
0.90
0.68, 1.18
0.4460


198
Lee, K_, Ferguson, D. M., Corpuz, M., & Gartner, L. M. (1988). Maternal age and the
incidence of low birthweight at term: A population study. American Journal of
Obstetrics and Gynecology. 158. 84-89.
Lennete, D. A. (1995). General principles for laboratory diagnosis of viral, rickettsial, and
chlamydial infections. In E. FL Lennette, D. A. Lennette & E. T. Lennette, (Eds.),
Diagnostic procedures for viraL rickettsial and chlamydial infections (pp. 97-120).
Washington, DC: American Public Health Association.
Li, D-K (1999). Changing paternity and the risk of preterm delivery in the subsequent
pregnancy. Epidemiology. 10(2). 148-152.
Lowe, S., & Saxe, J. M. (1999). Microscopic procedures for primary care providers (pp.
95-116). Philadelphia, PA: Lippincott, Williams & Wilkins.
Lumey, L. FL (1998). Compensatory placental growth after restricted maternal nutrition in
early pregnancy. Placenta. 19. 105-111.
Mahony, J. B., & Chemesky, M. A. (1985). Effect of swab type and storage temperature
on the isolation of Chlamydia trachomatis from clinical specimens. Journal of
Clinical Microbiology, 22151. 865-867.
Martens, M. G., Young, R L., Uribe, M., Buttram, V. C., & Faro, S. (1993). Presence of
chlamydia, mycoplasma, ureaplasma, and other bacteria in the upper and lower
genital tracts of fertile and infertile populations. Infectious Diseases in Obstetrics
and Gynecology, 1(2). 85-90.
Martin, D. H (1990). Chlamydia infections. Sexually Transmitted Diseases. 74(61. 1367-
1387.
Martin, D. H., Koutsky, L., Eschenbach, D. A., Daling, J. R, Alexander, E. R, Benedetti,
J. K, & Holmes, K. K. (1982). Prematurity and perinatal mortality in pregnancies
complicated by maternal Chlamydia trachomatis infections. Journal of the
American Medical Association. 247(11). 1585-1588.
Martius, J., Krohn, M. A., Hillier, S. L., Stamm, W. E., Holmes, K. K., & Eschenbach, D.
A. (1988). Relationships of vaginal Lactobacillus species, cervical Chlamydia
trachomatis, and bacterial vaginosis to preterm birth. Obstetrics and Gynecology.
71(1), 89-94.
Mason, P. R, & Brown, M. T. (1980). Trichomoniasis in pregnancy. Lancet 2. 1025.
MatchWare Technologies, Inc. (1997). AUTOMATCHL generalized record linkage
system, version 4,0. users manual Burtonsville, MD: MatchWare Technologies,
Inc.


39
direct visualization examples include gram stain for Neisseria gonorrhoeae and saline or
potassium hydroxide microscopy for bacteria vaginosis and candidiasis (Lowe & Saxe,
1999). Many commercial enzyme immunoassay tests for chlamydial and gonorrheal
antigens, and direct fluorescent antibody for visualization of chlamydial elementary bodies
have been available since the 1980s for wide spread screening programs. (Chemesky,
1999; Ehret & Judson, 1991; Fedorko & Smith, 1991). These tests have a sensitivity of
50% to 75% and specificity of 95% to 100% (Pate, Dixon, Hardy, Crosby, & Hook,
1998).
Highly sensitive nucleic acid amplification technology has become available more
recently. This method utilizes either target amplification, probe-amplification, or signal
amplification to detect minute numbers of organisms in a specimen. These tests are vastly
superior overall to culture or any other technology now available with sensitivity ranges of
95% to 100% and 99% to 100% specificity, (Kacena et al, 1998; Everett, Homnung, &
Anderson, 1999; Quinn et aL, 1996b). Two other studies with LCR show a similar range
of sensitivity. One conducted in France including women of both high (STD clinic) and
low risk (prenatal clinic) for chlamydial infection found an overal sensitivity of 95.2% and
specificity of 99.6% (de Barbeyrac, Rodriquez, Dutilh, le Roux, & Bebear, 1995). The
second study conducted in Florida among subjects from obstetric and gynecological clinics
reported the sensitivity as 97.6% and the specificity of 100% (Davis, Riley, Peters, &
Rand, 1998).
Pooling of chlamydia specimens will reduce the sensitivity slightly from 100% to
98.4%, but not for gonorrhea specimens as reported by researchers (Kacena et aL,1999;
Kacena, Quinn, Hartman, Quinn, & Gaydos, 1999). Pooling can provide even with minor


85
Term low birth weight (TLBW) was birth weight defined as greater than or equal
to 1500 grams and less than or equal to 2499 grams and gestational age equal to or
greater than 37 weeks. Pre-term low birth weight (PTLBW) was defined as LBW with
gestational age of equal or greater than 20 weeks and equal or less than 36 (Ventura,
Martin, Mathews, & Clarke, 1996; Graf & Perez-Woods, 1992). LBW, PTLBW and
TLBW were the dependent variables for the logistic regression models.
Gestational age was calculated from the date of birth and date of the last menstrual
period reported on the birth certificate (Ventura, Martin, Curtin, & Mathews, 1999).
Where the day of the month was missing the fifteenth was imputed (Buescher, Smith,
Holliday, & Levine, 1987). Reported gestational age in weeks had a slightly narrower
standard deviation (2.56) compared to that of estimated gestation (2.84). In addition, the
skewness for the reported gestation was larger (1.07) compared to the skewness for the
calculated gestation (0.42). When those births with computed gestational age less than 20
weeks and greater than 42 weeks (11.4%) were removed, the skewness was reduced even
further to (0.37), with a histogram that presents a more normal curve. Given this
information, the assumption was made that the calculated gestational age is more reliable
since the calculated gestational age exhibited a more standard bell-shaped curve than
reported gestational age. There may be bias in the reported gestational age data due to the
fact that reported gestation is recorded after the birth has occurred and the size, weight,
and appearance of the infant may influence the clinical estimate of gestational age. Some
researchers have expressed concern that calculated gestation from the LMP date
underestimates in the direction of pre-term deliveries (Kramer, McLean, Boyd, & Usher,
1988). There may also be recall bias associated with the calculated gestational age. The


231
To create dual infected variable.
compute ch=9.
if(ctresulm eq 1) ch=l.
if (ctresulm eq 2) ch=0.
missing values ch (9).
execute,
compute gc=9.
if (gcresulm eq 1) gc=l.
if (gcresulm eq 2) gc=0.
missing values gc (9).
execute.
compute gcch=9.
if (gc eq 0 and ch eq 0) gcch=l.
if (gc eq 1 and ch eq 0) gcch=2.
if (gc eq 0 and ch eq 1) gcch=3.
if (gc eq 1 and ch eq 1) gcch=4.
missing values gcch (9).
execute.
FORMATS gcch (F8).
VARIABLE LABELS gcch "gcch".
VALUE LABELS gcch 1 'no std' 2 'has gc' 3 'has ct' 4 lias both'.
FREQUENCIES
VARIABLE S= gcch
/ORDER ANALYSIS.
To create age groups.
RECODE
age (1 thru 10=0) (50 thru Highest=99) (11 thru 14=1) (15 thru 19=2) (20
thru 24=3) (25 thru 29=4) (30 thru 34=5) (35 thru 39=6) (40 thru 44=7)
(45 thru 49=8) INTO agegroup .
VARIABLE LABELS agegroup 'agegroup'.
EXECUTE.
*change decimal point then
VALUE LABELS agegroup
1 <14"
2"15-19"
3 "20-24"
4 25-29"
5"30-34"
6"35-39"
7 "40-44"
8"45-49"
99 "unk".
Execute.
VALUE LABELS V235


123
Table 9. Comparison Between Relational Database and Study Sample of Records
Identified for Use as the Independent Indicator Variables.
Births
Fetal Deaths
Totals
Relational
Database
190,497
1.501
191,998
Study Sample
13,914
88
14,002
Independent Indicator Variable
#
%
#
%
1. Age <18, >40
12,929
6.7
1,909
13.6
2. Alcohol use from birth record
1,700
0.9
158
1.1
3. Alcohol use from Healthy Start
11,933
6.2
1,910
13.6
4. Birth interval short
41,501
21.6
2,502
17.9
5. Chlamydia positive
437
0.2
285
2.0
6. High school no-
99,755
52.0
9,955
71.1
7. Gonorrhea positive
103
.01
51
0.4
8. Inadequate PNC indices
89,362
46.5
7,268
51.9
9. Inadequate weight gain
27,985
14.6
3,100
22.1
10. Married-not
67,556
35.2
8,491
60.6
11. Medical history
6,923
3.6
1,362
9.7
12. Mistimed pregnancy
37,194
19.4
7,266
51.9
13. Mom foreign bom
46,422
24.2
3,392
24.2
14. Mom LBW
8,251
4.3
1,376
9.8
15. Prior poor pregnancy outcome
16,963
8.8
2,761
19.7
16. Race of mother black
42,906
22.3
4,217
30.1
17. Rural residence
67,069
34.9
5,346
38.2
18. Smoking from birth record
23,524
12.3
2,871
20.5
19. Smoking from Healthy Start
19,401
10.1
4,114
29.4
20. STDs, past or current
768
0.1
340
2.4
21. Stressful life
73,601
38.3
13,102
93.6
unadjusted odds ratios, upper and lower confidence intervals and p-vahies are summarized
in Table 10 for LBW, Table 11 for TLBW and Table 12 for PTLBW.


24
This association was significant after adjustment and in the presence of IgG antibodies to
the serovars G (OR 6.6), D (OR 3.1), I (OR 4.4) and E (OR 2.3).
Other researchers have identified that cervical epithelial changes are significantly
associated with several reproductive tract infections. Singh and colleagues (1995)
examined a population of women attending a maternal health center in New Delhi, India.
A specimen was collected for a Pap smear. Other specimens were collected to screen for
chlamydia, gonorrhea, trichomoniasis, bacterial vaginosis, herpes simplex virus, genital
warts, HIV, syphilis, and candidiasis. If indicated, the woman also received a colposcopic-
directed biopsy for any atypical lesions. After controlling for interaction the adjusted odds
ratio for an association with inflammatory epithelial changes and chlamydia was 21.3,13.5
for human papillomavirus, and 22.6 for bacterial vaginosis. They observed a significant
additive effect: two infections increased the magnitude of inflammatory changes by
adjusted OR 31.4 and three infections by 72.6 fold. Young age was mildly protective and
parity greater than one increased the risk by OR 1.7
Today in an age of fetal STDs like HTV the rate of chlamydial infection in a
community is epidemiologically significant. A growing body of research provides evidence
that the population attributable risk from chlamydial infections is a predictor of increased
HTV transmission rates among young women and their partners (Laga et aL, 1993;
Plummer et aL, 1991). These researchers studied prostitutes prospectively and reported
adjusted odds ratios associating chlamydia with HIV-1 sero-conversion ranging from 3.2 -
5.7 with a median of OR 4.5. Laga and colleagues also calculated a population attributable
risk in their study population of 22% for increased HIV transmisson in the presence of


68
64 V-1 of the Florida Administrative Code provides clear direction on the preparation of
the certificate regarding paternity, maternity, birth attendance, the childs name and
surname, and residency. Local registrars provide regular training to hospital medical
records staff and the clerical staff responsible for completing the birth certificate (Office of
Vital Statistics, 1996b; R. Shepard, personal communications, June 30, 1999). The birth
record segments reflect the handbook directions and training provided to collect the
information from the numerous sources. The first segment has the legal demographic
information. This detail should be collected from the mother, father or other person with
knowledge of the frets. The second segment contains the medical and health history
information. The medical history detail should be collected from the medical records, with
both delivery and prenatal supplied to the hospital (or birth attendant, or center). The
details about the condition of the neonate should be collected from the neonatal unit
records, e.g., abnormal conditions of the newborn, anesthetic complications, etc.
Clear directions and regularly conducted training sessions do not necessarily
translate into accurate completion of birth certificates (Sammet, personal communications,
June 30, 1999). During the data entry process at the state registrars office, a staff member
telephones county health departments for clarification if they are unable to decipher data
on the birth certificate. Routine quality assurance reports are completed monthly to
identify outliers in data field. Habitual problems like late reporting, or high error rates in a
particular data fields are generally identified and addressed at the local registrars level
though consultation with the hospital administrators. Persistent problems and unusual
outliers in the data are addressed by visits to the hospital from the local registrar or from


192
GenProbe Incorporated. (1994b). Gen-Probe PACE2: Chlamydia trachomatis probe
competition assay [Package Insert]. San Diego, CA: Author.
Germain, M., Krohn, M. A., Hillier, S., & Eschenbach, D. A. (1994). Genital flora in
pregnancy and its association with intrauterine growth retardation. Journal of
Clinical Microbiology, 3219). 2162-2168.
Gest, C., Thompson, D. R_, & Hopkins, R. S. (1999). What is the effect of changes in
multiple birth rates on low birth weight rates? Epi update: A weekly publication by
the bureau of epidemiology. Available: www.doh.state.fLus.
Ghaem-Maghami, S. Hay, P. E., & Lewis, D. J. M. (1996). Antigen and isotope specificity
of human B cell responses in immunopathogenesis of genital Chlamydia
trachomatis infection, infectious Diseases in Obstetrics and Gynecology, 4. 179-
180.
Gittens, L. N., Nichols, R. R_, & Apuzzio, J. J. (1994). Epidemiology of sexually
transmitted diseases among pregnant adolescents. Infectious Diseases in Obstetrics
and Gynecology, 1(5). 216-219.
Gjerdingen, D. (1992). Premature labor, part I: Risk assessment, etiologic factors, and
diagnosis. Journal of American Board Family Practice. 5. 459-509.
Goldenberg, R. L., Andrews, W. W., Yuan, A. C., MacKay, EL T., & St. Louis, M. E.
(1999). Pregnancy outcomes related to sexually transmitted diseases. In P. J.
Hitchcock, H. T. MacKay & J. N. Wasserheit (Eds), Sexually transmitted diseases
and adverse outcomes of pregnancy (pp. 1-24). Washington, DC: American
Society for Microbiology.
Graf, R. A., & Perez-woods, R. (1992). Trends in preterm labor. Journal of Perinatology,
12(1), 51-57.
Gravett, M. G., Niesson, P., DeRouen, T., Critchlow, C., Eschenbach, D. A., & Holmes,
K K. (1986). Independent associations of bacterial vaginosis and Chlamydia
trachomatis infection with adverse pregnancy outcome. Journal of the American
Medical Association, 2561141. 1899-1903.
Grayston, J. T., Mordhorst, C. H, & Wang, S. (1981). Childhood myocarditis associated
with Chlamydia trachomatis infection. Journal of the American Medical
Association, 2461241. 2823-2827.
GrimpreL E., Sanchez, P. J., Wendell, G. D., Burstain, J. M., McCracken, G. H, Radolfi
J. D., & Norgard, M. V. (1991). Use of polymerase chain reaction and rabbit
infectivity testing to detect Treponema pallidum in amniotic fluid, fetal and


162
contribute to sustained inflammatory response. Others report that this sustained
inflammatory response may remain asymptomatic, with infants regularly infected as
demonstrated by transplacental passage of IgG antibodies collected from cord blood in
infants who remained symptom free for the first week of life (Djukie et aL, 1998).
While the research remains conflicting, it has been suggested that a pathogenesis
model of inflammatory response would explain apparent persistent chlamydiae presence,
as well. Beatty, Morrison and Byrne (1994) observed the presence of chlamydial antigen
and nucleic acids in culture negative specimens. Viable RBs may retain the capability to
stimulate immunopathologic changes, yet remain non-replicating. Bragina and Gomberg
(1998) observed atypical cytoplasmic inclusions in individuals where infection persisted
after unsuccesful antibiotic therapy. They noted that their latency could be distinguished
from persistency by the failure to demonstrate any metabolic processes. They suggest this
phenomenon of morphologically changed chlamydial bodies as a possible explanation for
persistence. As noted in a prior section, Dean and colleagues (1998) provided compelling
evidence of long-term persistence through analysis with ompl genotyping. In contrast,
Workowski and colleagues (1993) maintained that persistence did not follow adequate
treatment.
Immunity to most etiologic agents associated with sexually transmitted infections
remains poorly defined. Researchers have observed that the younger the patient, the
greater the likelihood that any given infection will be a primary infection. Brunham et aL
(1990) have suggested that it is likely that, in general, primary infections in a non-immune
host cause the greatest morbidity. In the study population, the rates of chlamydial infection
were significantly higher among the youngest of adolescents, as was low birth weight;


This dissertation was submitted to the Graduate Faculty of the College of Nursing
and to the Graduate School and was accepted as partial fulfillment of the requirements for
the degree of Doctor of Philosophy in Nursing.
December, 1999
lA L L /--L -Mrw
Dean, College of Nursing J
Dean. Graduate School


42
to 99% (Dinh & Martens, 1993; Stamm, 1999; Newhall et aL, 1999). The direct detection,
non-culture test employed to diagnose Chlamydia trachomatis genital infections, Gen-
Probe PACE2C, was used in this study. The test manufacturers published chlamydia
sensitivity ranges from 92.5% among those with a high (17.8%) positivity rate to 94.3%
among those with a low (4.1%) positivity rate (Gen-Probe Incorporated, 1994a).
Early studies conducted on persons who sought care in Florida county health
departments and elsewhere report a sensitivity of 96.4% for the Gen-Probe PACE2C
combination assay among asymptomatic and symptomatic females and males. The
prevalence ranged from 6.6% to 9.3% for chlamydia and from 6.6% to 56.5% for
gonorrhea, with a combined specificity in this same group of 98.0% (Hale, Melton,
Pawlowicz, Halstead & Wright, 1995; Hale, Melton, Lewis, & Willis, 1993; Schwebke &
Zajackowski, 1996). This technology may be less sensitive with male urethral specimens.
Khiytmans et aL (1991) reported a sensitivity of 70% among a male population with a
culture prevalence of 13.2%. In this same group the female sensitivity was 92.7% and
prevalence 8.6%.
More recent studies conducted with Gen-Probe PACE2C compared with DNA
amplification tests and other non-culture tests suggest that earlier studies may have over
estimated the sensitivity of this nucleic acid hybridization test (Newhall et aL, 1999; Wylie,
1998). Wylie et aL(1998) reported a prevalence of 10.4% and sensitivity of 79.3% among
a population of females residing in Manitoba Canada. Newhall et aL (1999) found a
prevalence of 3.9% and sensitivity of 75.3% and 75.3% respectively, among populations
of family planning patients from Washington and Oregon.


103
Strengths of the Study
Development of the relational database through the stringent processes employed
provided an opportunity to extract quality data from multiple files simultaneously with
assurance that the information pertained to the same individual or case. Additionally, the
linkage supported the creation of complex variables for the analysis using fields from
several files. The matched files also allowed for scrutiny of some demographic fields to
ascertain the level of concordance between databases. Finally, development of this
database has provided a source of data that will support further analysis and studies, as
well as a model for similar studies on this or other topics in the future.


50
Gillespie (1997) studied nicotine dependence among black and white women and reported
differences in plasma cotinine to cigarette ratios. Black women scored higher on plasma
cotinine levels; cotinine per cigarette ratio and carbon monoxide boost suggest ethnic
differences in nicotine metabolism. They also refer to information from other studies that
indicated black women sustained greater lung damage and less lung function recovery
following cessation than their white counterparts. These potential effects of smoking
among black women may potentiate the adverse impact on pregnancy and birth weight and
merit additional study to better understand the relationship of this risk factor.
Contribution of physiological and medical care factors. Weight gain has been
associated with fetal growth and consequent birth weight ranges (Abrams & Laros, 1986;
Seidman, Ever-Hadani, & Gale, 1989). Schieve, CogswelL and Scanlon (1999) examined
associations between weight gain per week of pregnancy and net weight gain per week of
pregnancy in a low-income urban population. Their findings suggest an association
between both low and high weight gain and PTL. They concluded that women with a
weekly weight gain at or near the Institute of Medicine guidelines for their respective body
mass index had the lowest risk of pre-term delivery. Abrams and Parker (1990) who
examined only term pregnancy outcomes reported that a wider range of maternal weight
gain than recommended in earlier published guidelines, was associated with good
outcomes. They also found no significance between maternal weight gain and SGA
infants.
Lumey (1998) examined the effects of under nutrition in pregnancy among infants
bom during 1944-1946 in the Netherlands and hypothesized that potential biological
compensatory mechanisms increase placental growth in conditions of under nutrition. The


171
This phenomenon was suspected with the observation of extreme outliers noted during
analysis, and addressed in the methodology applied.
One area of analysis that highlighted ongoing discussions in the literature was race
and ethnicity. Aspinall (1998) provides a comprehensive review of several concerns
regarding the use of race as a risk factor. While he suggests that ethnicity may be a more
suitable way to categorize individuals within the context of a study, he observes that it is
equally subject to flaws. In this study, there was an apparent discrepancy noted between
the coding of infant race, based on maternal and paternal distribution, and coding rules. As
noted in the prior chapter, ethnicity was hardly all encompassing due to a very restrictive
list of options available to those who enter the data. When the data in this study was
examined without regard to race, the scope of associations between the independent
variables and low birth weight was greater than in subsequent logistic models when race
and weight gain were controlled for. Simiarly, different patterns of association were noted
when women of white and black race were compared. Perhaps race as a variable in this
study is merely a marker for other contributory factors such as poverty. Rabin and others
(as cited by CDC, 1993) make this same suggestion.
Implications for Clinical Practice
The significant associations observed in this study between chlamydial infection in
pregnancy and low birth weight, suggest numerous opportunities to positively impact on
clinical practice. For example, urine-based tests for chlamydia and pregnancy should
become the standard practice for screening young reproductive age women who receive or
seek routine health care services while participating in school related sports activities, e.g.,


LIST OF FIGURES
Figure page
1. Chlamydia Rates Per 100,000 Females, Aged 15-44 Years:
Florida and the United States from 1994 1998 10
2. Chlamydiales Tree 29
3. The Developmental Cycle of Chlamydiae 32
4. Primary Steps in Research Analysis 106
IX


74
testing, and timely billing of providers. Following is a review of the system specifications
and the flow of data into that system, as regards specimens submitted for testing with the
Gen-Probe PACE2C nucleic acid hybridization technology (S. Crowe, personal
communication, June 29, 1999).
Beginning in December 1995, the Florida Department of Health, Bureau of
Laboratories commenced implementation of a long-range plan to computerize and store all
test-related data in an electronic system This represented a transfer from a hardcopy filing
system based on specimen ascension numbers to an electronic data system, allowing recall
of a particular test result(s) from numerous demographic or biological variables, and the
ascension number. Additionally, the database was structured to support centralized billing
to providers, regardless of the branch laboratory at which the specimen was processed.
Each laboratory was brought onto the new system sequentially, beginning with the main
branch site that processed the highest volume of specimens. By late-year 1996, all branch
laboratory computer systems were functional, as was the central statewide database.
During this same period many test reports from the branch laboratories actually were key
punched into the system at the central office she, to facilitate the billing process.
The system software written in Massachusetts Utility Multi Programming System
(MUMPS) language is a proprietary product. During 1996, h is run on a Unix platform
operating system through centralized servers linking the five branch laboratories. Data are
entered from personal computers located in each respective area of the laboratory. In the
routine course of laboratory operations specimens are received in the delivery/mailroom
At this initial point specimen labeling is matched against test requisition slip data for
accuracy, completeness in accordance with state and federal laws, and regulations


221
1.00000000000000 "TLBW >1500 <2499 >37wks".
execute.
compute LBWind3=0.
if (BWG eq 1 and gweeks ge 37) LBWind31.
if (BWG eq 1 and gweeks le 36) LBWind3=l.
if (BWG eq 2 and gweeks le 36) LBWind3=l.
missing values LBWind3 (-1).
FORMATS LBWind3 (F8).
VARIABLE LABELS LBWind3 "preterm low birth weight indicator".
VALUE LABELS LBWind3
.000000000000000 ,rNBW >2500"
1.00000000000000 "PTLBW >500 <2499 <36wks".
execute.
To create a marital status indicator variable.
compute maritali=0.
if (MMS=2) maritali=l.
missing values MMS (-1).
FORMATS marital! (F8).
VARIABLE LABELS maritali "marital status indicator".
VALUE LABELS maritali
.000000000000000 "married"
1.00000000000000 "not married".
FREQUENCIES
VARIABLES=maritali
/ORDER ANALYSIS .
To create a plural indicator variable to account for plural births.
BUT this only works if you have not first selected out the plural births!
compute phirindi=pluraL
recode plurindi (2, 3, 4, 5=1) (9=-l) (else=0).
missing values plurindi (-1).
FORMATS plurindi (F8).
VARIABLE LABELS plurindi "plural birth indicator".
VALUE LABELS plurindi
.000000000000000 "singleton birth"
1.00000000000000 "plural birth".
To create a maternal age indicator variable.
compute ageindic=0.
if (MAGE LT 18 or MAGE GT 40) ageindic=l.
missing values ageindic (-1).
FORMATS ageindic (F8).
VARIABLE LABELS ageindic "maternal age indicator".


107
match. However, it is believed the rate reflects the inconsistencies of demographic data
between different files. For example, many infants are not recorded with the same last
name in the early months, or may be addressed by the mother or guardian with what is
actually the middle name. As a result, this name may be used to requisition a laboratory
test or entered onto the medical record from which the morbidity case information may
have been extracted. Of the 126 infant morbidity cases relative to the parameters for a
1996 birth date, 110 were linked to a birth record (0.10%). From the 3,745 morbidity
records meeting the initial matching parameters 317 (0.2%) were linked to mothers, These
included 308 to birth records and 11 to fetal death records.
The Healthy Start prenatal screen database contained 191,333 records spanning
the period from 1995 through 1997. Of these, 59.6% (113,771) of the screens were linked
to a birth record and 44.3% (665) to a fetal death record. In total, no screen was matched
to more than forty percent of birth and fetal death records for the live births and fetal
deaths that occurred during 1996. The total number of records from each database is
presented below in Tables 4 and 5. The overall percent of records successfully linked is
very low for the STD maternal and infant case morbidity, the laboratory test database and
the congenital syphilis database.
Besides changing the scope of the data content available for analysis, halting the
data base construction also required a change in the methodology for extraction of the
final study sample. Originally, the study design included the county health department
service codes in order to identify all women who were health department patients for
inclusion at the first step of descriptive analysis. Inclusion and exclusion criteria of those
women who were both pregnant and had a linked chlamydia laboratory test would have


115
field immediately follows the last menstrual period and calculated estimated date of
delivery. It is completed during the prenatal care period when the prenatal screen is
offered and not likely to be associated with recall bias. However, it most likely is
completed prior to ultrasonic verification of gestational age. Based on this second option
for trimester of entry 61% of the study sample initiated care in the first trimester while
only 43% were identified as entering care in the first trimester for the general population
(valid percent based on Healthy Start variable). This finding is a marked difference from
official reported rates and is presented in Table 6.
For all births, 77.8% were delivered vaginally and 21.9% by Cesarean section.
Only those with a vaginal delivery were included in the study sample, due to exclusion of
those experiencing a Cesarean section. The Cesarean section rate is slightly higher than the
national rate of 20.7% and significantly higher than the rate for the total county health
department population (17.3%). One quarter of the general population and more than one
third of the study sample were identified as pregnant for the first time.
Nearly one fifth of the women in the study sample were identified as being of
Hispanic ethnicity, a slightly lower percentage than in the general population. Ethnicity is a
very misleading category in this database. Only eight ethnic options are allowed for data
entry. These include 1) non-Hispanic, 2) Mexican, 3) Puerto Rican, 4) Cuban, 5) Central
or South American, 6) other, 7) Haitian, and 8) unknown. Hence ethnicity in this data set
literally indicates membership in some broad grouping of Hispanic ancestry, ranging from
the Caribbean though Central and South America.
Close to two thirds of the study population were of white race compared to three
quarters of all women. Of interest was the subtle shift in identified race for the infanta In


189
Desenclos, J-C. A., Garrity, D., Scaggs, M., & Wroten, J. E. (1992). Gonococcal
infection of the newborn in florida, 1984-1989. Sexually Transmitted Diseases.
119(21. 105-110.
Dink T. A., & Martens, M. G. (1993). Chlamydia testing in pregnancy: When is a positive
a positive? The American Journal of Gynecologic Health. 7(41. 11-15.
Djukie, S., Nedeljkovic, M., Pervulov, M., Vesic, S., Ljubic, A., & Vranes, B. (1998).
Prevalence of Chlamydia trachomatis antibodies in cord blood. [Abstract]
Presented at International Symposium on Immunopathogenesis of Chlamydia
Infections, New York, NY. Infectious Diseases in Obstetrics and Gynecology. 4.
184-185.
Dorfman, D. H. & Glaser, J. H. (1990). Congenital syphilis presenting in infants after the
newborn period. New England Journal of Medicine. 323(191. 1299-1302.
Dreses-Werringloer, U., Jurgens, B., Zeidler, H., & Kohler, L. (1998). Persistence of
Chlamydia trachomatis and chlamydial antigens in HEP-2 and THP-1 cells after
treatment with ciprofloxacin. [Abstract] Presented at International Symposium on
Immunopathogenesis of Chlamydia Infections, New York, NY. Infectious Diseases
in Obstetrics and Gynecology. 4. 185-186.
Duncan, J., Nagle, B., Streeter, N., Bloemaum, L., & Tingey, T. A. (1998). Risk factors
for short interpregnancy interval- Utak June 1996 June 1997. Morbidity and
Mortahty Weekly Review., 47(43).
Dunkel-Schetter, C. (1998). Maternal stress and preterm delivery. Prenatal and Neonatal
Medicine. 3(11. 39-42.
Ehret, J. M., & Judson, F. N. (1991). Gonorrhea. In B. B. Wentworth, F. N. Judson & M.
J. R. Gilchrist, (Eds.) Laboratory methods for diagnosis of sexually transmitted
diseases. (2nd ed., pp. 53-94). Washington, DC: American Public Health
Association.
Eschenbach, D. A. (1998). Amniotic fluid infection is a fetal infection. Prenatal and
Neonatal Medicine. 3(11. 76-81.
Eschenbach, D. A. (1999). Bacterial vaginosis. In P. J. Hitchcock, H. T. MacKay & J. N.
Wasserheit (Eds), Sexually transmitted diseases and adverse outcomes of
pregnancy (pp. 103-123). Washington, DC: American Society for Microbiology.
Everett, K D. E., Homnung, L. J., & Anderson, A. A. (1999). Rapid detection of the
Chlamydiaceae and other families in the order Chlamydiales: Three PCR tests.
Journal of Clinical Microbiology. 37(31. 575-580.


220
LLBM "last live birth month" LLBD "last live birth day" DOTdays "last other termination
total days" DOTY 'last other termination year" DOTD 'last other termination day"
lastpreg "days since most recent pregnancy" birthint "birth interval in days" Blindic "birth
interval indicator" .
FORMATS Blindic (F8).
VALUE LABELS Blindic
.000000000000000 "0- birth interval adequate"
1.00000000000000 "1- birth interval inadequate" .
FREQUENCIES
VARIABLES= LLBdays DOTdays lastpreg birthint Blindic
/ORDER ANALYSIS .
To create a rural indicator variable.
compute ruralind=MRCNTY.
recode ruralind (49, 32, 29, 17, 31, 73, 25, 43, 34, 33, 40, 72, 50, 75, 77, 12, 35, 14, 24,
36,
48, 71, 57, 76, 28, 70, 42, 30, 55, 22, 64, 38, 54=1) (else=0).
if (ruralind=0 and MRLIM=2) ruralind=l.
missing values ruralind (-1).
FORMATS ruralind (F8).
VARIABLE LABELS ruralind "rural indicator".
VALUE LABELS ruralind
.000000000000000 "urban"
1.00000000000000 "rural" .
To create a LBW indicator variable.
compute LBWindic=0.
if (BW GE 500 and BW LE 2499) LBWindic=l.
if (BW LE 499) LBWindic=-l.
missing values LBWindic (-1).
FORMATS LBWindic (F8).
VARIABLE LABELS LBWindic "low birth weight indicator".
VALUE LABELS LBWindic
.000000000000000 "NBW >2500"
1.00000000000000 "LBW >500 <2499".
execute.
compute LBWind2=0.
if (BWG eq 1 and gweeks ge 37) LBWind2=l.
if (BWG eq 1 and gweeks le 36) LBWind21.
if (BWG eq 2 and gweeks le 36) LBWind21.
missing values LBWind2 (-1).
FORMATS LBWind2 (F8).
VARIABLE LABELS LBWind2 "term low birth weight indicator".
VALUE LABELS LBWind2
.000000000000000 "NBW >2500"


LIST OF REFERENCES
Abrams, B. F., & Laros, R. K (1986). Prepregnancy weight, weight gain, and birth
weight. American Journal of Obstetrics and Gynecology. 154(31. 503-509.
Abrams, B. F., & Parker, J. D. (1990). Maternal weight gain in women with good
pregnancy outcome. Obstetrics and Gynecology. 7611). 1-7.
Ahijevych, K., & Gillespie, J. (1997). Nicotine dependence and smoking topography
among Black and White women. Research in Nursing and Health. 20. 505-514.
Ahluwalia, I. B., Hogan, V. K., Grummer-Strawn, L., Colville, W. R., & Peterson, A.
(1998). The effect ofwic participation on smafl-for-gestational-age births,
Michigan, 1992. American Journal of Public Health. 88(9). 1374-1377.
Alexander, G. R., & Kotelchuck, M. (1996). Quantifying the adequacy of prenatal care: a
comparison ofindices. Public Health Reports. 111(5). 408-419.
Alexander, G. R., Tompkins, M. E., Petersen, D. J., & Wesis, J. (1991). Source of bias in
prenatal care utilization indices: Implications for evaluating the medicaid
expansion. American Journal of Public Health. 81(81. 1013-1016.
Alexy, B., Nichols, B., Heverly, M. A, & Garzn, L. (1997). Prenatal factors and birth
outcomes in the public health service: A rural urban comparison. Research in
Nursing and Health. 20. 61-70.
Allaire, A D., Huddleston, J. F., Graves, W. L., & Nathan, L. (1998). Initial and repeat
screening for Chlamydia trachomatis during pregnancy. Infections Diseases in
Obstetrics and Gynecology, 6. 116-122.
Anderson, K N., Anderson, L. E., & Glanze, W. D. (Eds). (1994). Mosbvs medicaL
nursing, and allied health dictionary (4th Edition). St. Louis, MD: Mosby.
Askienazy-EIbhar, M. (1996). Immune consequences of chlamydia infections in pregnancy
and in vitro fertilization outcome, infectious Diseases in Obstetrics and
Gynecology, 4. 143-148.
Aspinall, P. J. (1998). Describing the White ethnic group and its composition in medical
research. Social Sciences and Medicine. 47(111. 1797-1808.
182


168
data set to evaluate these and other behaviors or conditions that may have contributed to
the strength of the observed association between inadequate weight gain and low birth
weight.
Other maternal medical conditions may confound or amplify the risk of low birth
weight in women with less than ideal weight gain during pregnancy. For example, iron
deficiency anemia may increase the risk of inadequate weight gain in the first and second
trimesters (CDC, 1999b). Data from the 1996 Pregnancy Nutrition Surveillance System,
suggested that 40% of black women and 29% of all women had anemia in the third
trimester. While history of maternal medical conditions were controlled for in this study,
closer examination of the interactions between anemia and other medical conditions such
as preeclampsia, body mass index and weight gain are warranted. Particularly in light of
reported low levels of reporting on medical risk factors observed by researchers
(Woolbright & Harshbarger, 1995; Woolbright, Hilliard, Harshbarger, & Wertelecki,
1999).
Smoking was strongly identified with all levels of low birth weight events among
women with less than recommended weight gain in this study (OR 1.76, OR 2.35 and OR
1.67). Data from the Healthy Start prenatal screen tobacco use indicator, revealed women
in this sample were smoking at a similar rate as pregnant women surveyed nationally,
29.4% compared to 23-37% in the Pregnancy Nutrition Surveillance System (CDC,
1999b). Between those identified from the birth record as having ever smoked, and those
identified from the Healthy Start prenatal screen as having used tobacco in the last two
months, the rates of low birth weight were similar (8.2% and 7.0% respectively). This rate


58
and IPI of 0-3 months. No significant association was observed for the IPI of 4 to 24
months.
Prior LBW events and prior pre-term deliveries have been reported as significantly
associated with an increased risk for subsequent LBW and PTL events. The birth record
and the Healthy Start prenatal screen both contain fields to capture information related to
prior poor birth outcomes. Hulsey and others (1998) reported a 2.8 times increased risk
for a subsequent pregnancy with PTL, following an initial pre-term delivery. The authors
calculated a population attributable risk that attributes 22.5% of second pre-term
deliveries to having had one previously. Black women experienced an overall greater rate
of pre-term deliveries, but if a white woman delivered prematurely on the first pregnancy
she was at a 4.5 times increased risk compared to black women with 2.5 increased risk.
Another risk for poor outcomes may be the role of the father. One study, reported
that among women who changed partners after their first delivery before 34 weeks, a 33%
reduction in the risk of a subsequent early pre-term delivery was observed compared with
those who did not change partners (Li, 1999). Among women who had initially delivered
at gestation over 36 weeks, changing partners increased their risks of a subsequent pre
term by 16%. Among women between 34 and 36 weeks no effect was observed with the
changing of partners. The weight of the father may also contribute to increased risk of low
birth weight delivery for his partner. Klebanoff and others (1998) studied the offspring of
an historic Danish cohort combining data from birth registries, military records and
midwifery records. They found a significant association between paternal birth weight and
the subsequent birth weight of their offspring, independent of the maternal birth weight.
Other researchers have demonstrated an association between a womans birth weight and


117
Table 7. Comparison Between Relational Database and Study Sample of Selected
Variables Used in Combination to Create Independent Indicator Variables for the Logistic
Modeling.1
Relational Database
Study Sample
Births
190,497
13,914
Fetal Deaths
1.501
88
TOTALS
191,998
14,002
#
%
#
%
Timing of pregnancy
Earlier
4,348
3.8
672
4.8
Later
25,187
22.0
5,142
36.7
Not at all
7,659
6.7
1,452
10.4
Timing is okay
40,853
35.7
6,699
47.8
History of medical complications
6,923
3.6
1362
9.7
Mother LBW at birth yes
8,251
4.3
1,376
9.8
Body mass index
Low
51,551
35.7
6,545
25.3
Normal
39,070
27.1
6,564
46.9
High
9,145
6.3
1,159
11.5
Obese
14,670
10.2
2,334
16.7
Prior poor pregnancy outcome
16,963
8.8
2,761
19.7
Plural birth
5,106
2.6
-
-
Resides outside of city limits
61,366
32.0
4,356
31.1
Stressful life questions
Difficulty keeping appointments
5,800
5.1
1,714
12.2
Moved > 3x in 12 months
7,745
6.8
1,882
28.8
Feels unsafe
3,461
3.0
693
53.7
Hunger
2,492
2.2
711
17.3
Physical violence
4,871
4.3
1,143
4.8
Stress level low
22,121
19.5
4,032
36.7
Stress level medium
42,989
37.6
7,515
10.4
Stress level high
12,997
11.4
2,429
47.8
Chronic illness
6,818
6.0
1,354
9.7


197
behavior advice andinitial prenatal care procedures. Journal of the American
Medical Association. 271(171. 1340-1345.
Kogan, M. D., Martin, J. A., Alexander, G. R., Kotelchuck, M., Ventura, S. J., &
Frigoletto, F. D. (1998). The changing pattern of prenatal care utilization in the
United States, 1981-1995, using different prenatal care indices. Journal of the
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Koehler, L., Nettelbreker, E., Hudson, A., Gerard, FL, Bonk, D., & Zeidler, FL (1996).
Variability of non-cuhurable Chlamydia trachomatis persisting in human
peripheral blood monocytes and human monocytic THP-1 cells. Infectious
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gestational age estimation by menstrual dating in term, preterm, and postterm
gestations. Journal of the American Medical Association. 260. 3306-3308.
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(1999). The impact on accuracy and cost of ligase chain reaction testing by pooling
urine specimens for the diagnosis of Chlamydia trachomatis infections. Sexually
Transmitted Diseases. 26(91. 504-507.
Laga, M., Manoka. A., Kivuvu, M., Malele, B., Tuliza, M., Nzila, N., Goeman, J., Behets,
F., Batter, V., Alary, M., Heyward, W. L., Ryder, R. W., & Piot, P. (1993). Non
ulcerative sexually transmitted diseases as risk factors for HIV-1 transmission in
women: Results from cohort study. AIDS. 7(1). 95-102.
Laga, M., Plummer, F. A., Piot, P., Datta, P., Namaara, W., Ndinya-Achola, J. O.,
Nsanze, FL, Maita, G, Ronald, A. R_, Pamba, H. O., & Brumham. R. C. (1988).
Prophylaxis of gonoccocal and chlamydial opthahrria neonatorum. New England
Journal of Medicine. 318. 653-657.
Larson, E. FL, Hart, L. G., & Rosenblatt, R. A. (1997). Is non-metropolitan residence a
risk factor for poor birth outcome in the US? Social Science Medicine. 45121. 171-
188.
Larson, S. A., Hunter, E. F., & McGrew, B. E. (1991). Syphilis. In B. B. Wentworth, F.
N. Judson & M. J. R. Gilchrist (Eds.) Laboratory methods for diagnosis of
sexually transmitted diseases. (2nd ed., pp. 1-52). Washington, DC: American
Public Health Association.
Launer, L. J., Villar, J., Kestler, E., & Onis, M. (1990). The effect of maternal work on
fetal growth and duration of pregnancy: A prospective study. British Journal nf
Obstetrics and Gynecology, 97. 62-70.


62
Bacterial vaginosis has been identified in a significant number of studies as strongly
associated with pre-term low birth weight. The Vaginal Infections and Prematurity Study
Group reported an odds ratio of 1.4 for bacteria vaginosis and preterm delivery of a low
birth weight infant (Holier et aL, 1995). The Patient Outcomes Research Team (1998)
reported that bacterial vaginosis in women of black race/ethnicity accounts for 40% of
excess pre-term births. They also demonstrated that antibiotic treatment for bacterial
vaginosis in pregnancy reduced pre-term deliveries. Eschenbach (1999) and HOlier and
Holmes (1999) provide comprehensive reviews of bacterial vaginosis. The authors note
the strong associations between this infection and adverse pregnancy outcomes, and the
positive impact (albeit conflicting impact) that treatment during pregnancy has in reducing
incidence of prematurity. Eschenbach also provides a discussion on the potential
association between fetal and maternal immune response in the presence of infection with
bacterial vaginosis.
The actual impact on low birth weight from bacterial vaginosis is probably
underestimated since this condition is roughly twice as common as other reportable STDs
and also asymptomatic. However, a recently completed national multi-centered study
failed to provide the needed evidence that treatment for bacterial vaginosis during
pregnancy reduces the likelihood of prematurity or low birth weight (Hillier, 1998). Two
other areas of concern with bacterial vaginosis (BV) are the non-sexual acquisition of the
syndrome and the role of BV in HIV acquisition. Black women are three times more likely
to have BV regardless of the number of sexual partners, and in the absence of sexual
partners. In contrast white women are more likely to develop or acquire the condition with
increasing number of partners (Hillier, 1998). Numerous studies suggest that BV enhance


116
both groups there were slightly more infants of black race. Both populations had a similar
percent of women who were foreign bom. The percent reported as other does not make
up this difference. The birth and fetal death record coding instructions assign black race to
all children bom of black mothers except when the fathers race is reported as Asian or
American, then the child is assigned the particular race code for the fathers country of
origin. In the case of infants for whom the fathers race is unknown, the child is also
assigned black race from the mother. Please refer to Table 6.
In categories of pregnancy timing for those records with a Healthy Start prenatal
screen, women generally reported less dissatisfaction with the timing of their pregnancy,
yet significantly fewer stated that the timing was acceptable. Please refer to Table 7. This
variable is markedly affected by the 30% who declined to answer the question altogether,
even though a screen was linked. Only one third as many women in the general population
were identified with a medical history. Twice as many women reported having been
themselves of 5.5 pounds or less at birth. More than twice as many women in the sample
reported a prior poor pregnancy outcome. This is interesting considering that the overall
rate of low birth weight was lower for the study sample than observed for the combined
1996 birth and fetal death records (6.9% compared to 8.1% respectively). This pattern
was also noted for the proportion of fetal death records, with 0.78% observed in the
relational database and 0.63% in the study sample.
Marked differences were observed for body mass index between the two groups,
most likely the result of missing values on this variable for the larger group. Forty percent
more women were calculated to have a low body mass index among the larger group.


12. Unadjusted Odds Ratios for Pre-Term Low Birth Weight. Based
on Bi-variate Analysis of Independent Variables in
the Study Sample 127
13. 1996 Statewide Chlamydia and Gonorrhea Prevalence Estimates based on
Laboratory Test Results 130
14. Adjusted Odds Ratios, Based on Logistic Regression,
for all Variables 133
15. Adjusted Odds Ratios, Based on Logistic Regression,
without Race Variable 137
16. Adjusted Odds Ratios, Based on Logistic Regression,
for White Race 140
17. Adjusted Odds Ratios, Based on Logistic Regression,
for Black Race 143
18. Adjusted Odds Ratios, Based on Logistic Regression,
for Inadequate Weight Gain 147
19. Adjusted Odds Ratios, Based on Logistic Regression,
for Adequate Weight Gain 151
20. Comparison of Sexually Transmitted Disease Findings for
the Study Sample 155
viii


3
area of the country (Allaire, Huddleston, Graves, & Nathan, 1998; Gittens, Nichols, &
Apuzzio, 1994). Recent research suggests that the bacteria invade human host cells
within minutes, cross the placental barrier to invade amniotic cells, and cause
chorioamnionitis (Patton et aL, 1998; Thomas, Jones, Sbara, Cetrulo, & Reisner, 1990).
During the period from 1981 to 1997, the rates of low birth weight (LBW) have
overall decreased from 8.8% to 7.5% nationally (Ventura, Martin, Curtin, & Mathews,
1999). However, since 1988 there has been a creeping upward trend from 6.9 to 7.5 in
1997, the highest since 1973. During this similar period of time in Florida, there has been
an increase from 7.5% in 1980 to 8.1% in 1998 (Office of Vital Statistics, 1996a, 1999).
Not the entire upward trend is attributable to increases in multiple births among older
women secondary to treatment for infertility. Multiple contributing factors have been
identified. Nationally, low birth weight among singleton births rose from 6.03% in 1996
to 6.08% in 1997, or 4% since 1986 (Ventura, Martin, Curtin, & Mathews, 1999). The
group most affected were black women with an increase of 10.3%. Recent analyses of
Duval County, Florida births suggest the following factors may be involved with the
changing rates: 1) increased numbers of multiple deliveries, by 0.36 for 1998 over the
prior year; 2) increased LBW among multiple births, especially twins; 3) LBW among
singleton deliveries has increased; 4) increased numbers of births to women of black
race/ethnicity, up 3% in 1998; and 5) a downward trend for births reported with
macrosomia (Gest, Thompson, & Hopkins, 1999).
Nationally the numbers of women who initiated prenatal care early and received
at least the recommended number of visits increased during the period from 1981 to 1995
(Kogan et aL, 1998). Yet the rates of low birth weight have continued to rise slowly. One


129
from >1 to 5% of the total test reports with test volumes ranging from 1,311 to 5,944.
Two counties are represented with volumes of >5 to 10% (5.6%, 6.9%) and two counties
represent more than 10% each (11.2%, 12.4%) of the total test report database. Less than
1% of reports are associated with no identified county of specimen origin. The findings are
presented in Table 13 below. No chlamydia related laboratory test results are available for
the general population delivering during 1996.
Age is reported on nearly all records with only 0.6% identified as age unknown.
The span of age groups between 15 and 34 years, represents 81.8% of the test reports.
Gender is identified on 99% of reports. Program code is identified on 77.4% of the
specimen reports with 11.3% identified as collected from women who received prenatal
care services. Of the five branch laboratory sites, Jacksonville is over represented,
contributing 63% of the specimen reports, and Pensacola is second with 12.9%.
Race/ethnicity is identified on all but 3.3% of the reports.
The highest positivity for chlamydia is among those under twenty years of age,
with 15 to 19 year olds reported at 9.3% and <15 years at 9.6%. Those women identified
as being of black race/ethnicity have greater than twice the positivity of whites in this
database (7.5% and 3.0% respectively) with males nearly twice the rate of females (7.3%
and 4.2% respectively). The positivity at 5.5% for chlamydia specimens collected from
prenatal clinics is greater than that of all other program areas except for STD clinic
settings. In contrast, the highest positivity for gonorrhea specimens is 11.1% from STD
clinics, followed by 6.7% from unknown clinic settings. The rate of dual infection with


52
overall do not measure content, capture gaps in visits, or adequately consider high-risk
pregnancy visit schedules (Stringer, 1998). The inadequacy of the different indices to
accurately quantify adequacy is highlighted in the numerous studies that have compared
the different measures to the same sample population. Alexander and Kotelchuck applied
five measures to data files containing 169,082 singleton births. The proportion of cases
assigned to each utilization category (adequate, inadequate, etc.) ranged from 34% to
58% for adequate care, 9% to 20% for inadequate care, and 7% to 27% for intensive
utilization.
The Kessner index was applied in a North Carolina study that compared infant
birth weight for women receiving their care at the health departments or from other
providers who accepted Medicaid (Buescher, Smith, Holliday, & Levine, 1987). Medicaid
women who received care from other providers were at twice the risk of having a LBW
infant compared to those who received their care at the health department. Augustyn and
Maiman (1994) utilized the 1988 Institute of Medicine indices to examine psychological
and sociological barriers to prenatal care from the reported literature. Another research
group examined the national changing pattern of prenatal care utilization with four of the
published indices (Kogan, Martin, Alexander, Kotelchuck, Ventura, & Frigoletto, 1998).
Markedly different trends were produced with the different indices. Virtually no change in
utilization for adequate or intensive care was reported using the IOM index, while an
increasing trend was noted for more adequate and intensive prenatal care utilization was
reported with the R-GINDEX and APNCU index. Differing patterns of utilization and
trimester of entry for by teenagers ranged from 2.9% to 16.3% and 12.6%respectively.


41
combined with the cost of culture, have contributed to the widespread popularity of the
direct detection methods commercially available since the 1980s.
Numerous forms of serologic tests have been useful for the detection of sexually
transmitted infections. However, only T. pallidum, C. trachomatis, human
immunodeficiency virus (HTV), hepatitis B virus (HBV), and herpes simplex virus (HSV)
have an adequate immune response in current infection for serologic testing (Chemesky,
1999; Chemesky et aL, 1998). With these responses there is also significant variability,
reducing the reliability of this technique for laboratory diagnosis and restricting its
application to specific situations. In the case of Chlamydia trachomatis the antibody
response elicited during infection may be long lived, therefore serology for identification
of lower tract syndromes has not been successful. (Black, 1997, 1998). Serology is useful
in diagnosis of infant chlamydial pneumonia and HTV, HBV, and HSV. Serology has been
invaluable in the epidemiologic study of chlamydial infections in different populations
(Numazaki, 1998; Gencay et aL, 1995; Harrison et aL, 1983; Numazaki & Chiba, 1996;
Numazaki, Kusaka, & Chiba, 1996; Fejgin et aL, 1997; Cohen, Tenenbaum, Michaeli,
Beyth, & Sarov, 1990). First used as a screening test in diagnosis of non-lesion syphilis
before World War II, serology has proven to be very effective in the control of this STD
(Brandt, 1985; Pynchon, 1964). However, even with positive serology for T. pallidum in
an individual for whom a darkfield examination or direct antibody test is not available,
confirmation should be sought with the use of a treponemal test technique to identify false
positives (Chemesky, 1999; CDC, 1998b).
In populations with low to moderate prevalence, as observed in the study sample,
the sensitivity of the non-culture tests range from 50% to 96% and the specificity from 93


169
is significantly lower than the rate reported by the Prenatal Risk Assessment Monitoring
System for the following year in Florida, 18.2% (CDC, 1999c).
Hickey and colleagues (1997) found in their study that women of black
race/ethnicity were twice as likely to experience low prenatal weight gain with a mistimed
pregnancy than those who reported that the timing of their pregnancy was acceptable, or
who were of another race/ethnicity. In the present study, this finding was not confirmed.
Among black women who reported that the timing of their pregnancy was acceptable,
24.7% had an inadequate weight gain compared to 26.8% who reported that their
pregnancy was mistimed. When inadequate weight gain was examined within the context
of other independent variables such as inter-pregnancy interval, it was observed that both
women of white or black race/ethnicity with inadequate weight gain (20%) were equally
affected by a relationship between short inter-pregnancy interval and low birth weight. The
two groups of women had similar rates of low birth weight, 12% and 12.7%. Rawlings et
aL (as cited in Institute of Medicine, 1992) found a more pronounced difference between
the two racial/ethnic groups. He and colleagues reported an increased risk for white
women only, with short inter pregnancy interval of three months compared to black
women for nine months. The differences observed between race/ethnic groups and inter
pregnancy intervals, merit further analysis to identify their significance. Equally important
would be further analysis to gain more insight into why the observed increased risk for low
birth weight associated with inadequate weight gain appeared to affect white women more
than black women in the logistic modeling. A recent unrelated study looking at mortality
and body mass index, observed that black men and women had lower risks of death with


43
Gen-Probe PACE2C employs the principle of nucleic acid hybridization method.
The concept behind this technology is based on the re-pairing of specific nucleotide bases
that compose the ribonucleic acid (Foorghani & Erdman, 1995). The double-stranded
target ribosomal ribonucleic acid (rRNA) of the chlamydia or gonorrhea organisms is
dissociated and re-paired with a chemiluminescent single strand probe which can be read
by the testing equipment. This process is based on a biological in vivo amplification of
rRNA Many more copies of rRNA (5,000 to 10,000) exist in an individual cell as
compared to a single deoxynucleic acid (DNA) strand. This is a different testing
methodology from DNA amplification utilized in PCR, LCR, TMA, and SDA testing. As
with DNA amplification, rRNA hybridization increases the likelihood that the chlamydia or
gonorrhea organisms will be identified in the specimen as compared to some other
technologies, however the sensitivity does not approach that of amplification.
Confounding Factors and Quality of STD Specimens Submitted for Testing.
Specimens submitted for chlamydia, or other STD testing, may be adversely
affected by any number of clinician-controlled behaviors, laboratory management,
transportation interval, and patient-related issues. Among the many variables controlled by
the level of clinician skills and knowledge are: choice of collection implements, the
presence of excessive blood, mucous, pus or exudate, exfoliated cells, vaginal secretions,
debris, fibers, and lubricants included with the specimens).
Other factors confounding specimen quality are the availability of supplies in the
clime, types of instruments and implements as well as their consistent supply. This issue is
one faced by all providers, public health as well as private (Pachciarz et aL, 1992; Steiner,


151
OR 1.59, a history of a prior poor pregnancy outcome
OR 1.48, age less than 18 years or more than 40 years
OR 1.43, indices of inadequate prenatal care visits during pregnancy
Table 19. Adjusted Odds Ratios, Based on Logistic Regression, for Adequate Weight
Gain.
Low Birth Weight
Variable
OR
95% Cl
p value
Age < 18, >40
1.43
1.12, 1.81
0.0035
Mistimed pregnancy
0.80
0.67, 0.96
0.0161
Medical history
1.32
1.02, 1.72
0.0349
Prior poor pregnancy outcome
1.71
1.41,2.09
0.0000
Race of mother black
2.33
1.93, 2.81
0.0000
Smoking from birth record
1.87
1.52, 2.30
0.0000
Term Low Birth Weight
Variable
OR
95% Cl
p value
Age < 18, >40
1.48
1.01,2.16
0.0437
Alcohol use from Healthy Start screen
1.63
1.15, 2.30
0.0062
Gonorrhea positive
5.11
1.77,14.75
0.0025
Inadequate PNC indices
1.43
1.08, 1.90
0.0115
Prior poor pregnancy outcome
1.59
1.16, 2.18
0.0037
Race of mother black
2.07
1.53, 2.80
0.0000
Smoking from birth record
2.19
1.59, 3.01
0.0000
Pre-Term Low Birth Weight
Variable
OR
95% Cl
p value
Age < 18, >40
1.48
1.06, 2.07
0.0204
Inadequate PNC indices
1.34
1.04, 1.73
0.0252
Prior poor pregnancy outcome
1.88
1.42, 2.49
0.0000
Race of mother black
2.43
1.86,3.17
0.0000
Smoking from birth record
1.48
1.07, 2.03
0.0163


193
neonatal sera, and cerebrospinal fluid. Journal of Clinical Microbiology. 29(8).
1711-1718.
Gutman, L. (1999). Gonococcal diseases in infants and children. In K.K. Holmes, P. F.
Sparling, P. A. Mardh, S. M. Lemon, W. E. Stamm, P. Piot, & J. M. Wasserheh
(Eds.), Sexually transmitted diseases (3rd ed., pp. 1145-1153). New York, NY:
McGraw-Hill, Inc.
Hale, Y. M., Melton, M. E., Lewis, J. S., & Willis, D. E. (1993). Evaluation of the
PACE2 Neisseria gonorrhoeae assay by three public health laboratories. Journal of
Clinical Microbiology. 31 (2), 451-453.
Hale, Y. M., Melton, M., Pawlowicz, M., Halstead, D., & Wright, F. (1995, May). An
evaluation of the gen-probe PACE2 system for Chlamydia trachomatis and
Neisseria gonorrhoeae in a high prevalence population. Poster session presented at
the American Society of Microbiology Meeting, Washington, DC.
Hammerschlag, M. R. (1999). Chlamydial infections in infants and children. In KK
Holmes, P. F. Sparling, P. A. Mardh, S. M. Lemon. W. E. Stamm, P. Piot & J. M.
Wasserheit, (Eds.), Sexually transmitted diseases (3rd ed.. pp. 1155-1164). New
York, NY: McGraw-Hill, Inc.
Hammett, T. M., Kaufman, J. A., Faulkner, A H, Hoaglin, D. C., & Bataglia, M. P.
(1996). Sexually transmitted disease (std) prevention in the United States:
Integrated evaluation of public and private sector disease reporting and service
delivery (CDC No. 200-93-0633). Cambridge, MA: Abt Associates, Inc.
Hardy, P. H., Nell E. E., Spence, M. R_, Hardy, J. B., Granham, D. A., & Rosenbaum, R.
C. (1984). Prevalence of six sexually transmitted disease agents among pregnant
inner-city adolescents and pregnancy outcome. Lancet. 3. 333-337.
Hardy, A V., & Pynchon, M. (1964). Millstones and milestones: Floridas public health
from 1889. Jacksonville, FL: Florida State Board of Health Monograph Series No
7.
Harger, J. H, Meyer, M. P., Amortegui, A., Macpherson, T. V., Kaplan, L., & Muefler-
Heubach, E. (1991). Low incidence of positive amniotic fluid cultures in preterm
labor at 27-32 weeks in the absence of clinical evidence of chorioamnionitis.
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Harrison, H. K, & Alexander, E. R. (1990). Chlamydial infections in infants and children.
In KK Holmes, P. A. Mardh, P. F. Sparling & P. J. Wiesner, (Eds.) Sexually
transmitted diseases (pp. 811-820). New York, NY: McGraw-Hill, Inc.
Harrison, H. R_, Alexander, E. R., Weinstein, L., Lewis, M., Nash, M., & Sim, D. A.
(1983). Cervical chlamdia trachomatis and mycoplasmal infections in pregnancy
epidemiology and outcomes. Journal of the American Medical Association.
250(131. 1721-1727.
Hauth, J. C. Goldenberg, R. L. Andrews, W. W., Dubard, M. B., & Copper, R. L. (1995).
Reduced incidence of preterm delivery with metronidazole and erythromycin in
women with bacterial vaginosis. New England Journal of Medicine. 333. 1732-
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Hedegaard, M., Henriksen, T. B., Sabroe, S., & Secher, N. J. (1996). The relationship
between psychological distress during pregnancy and birth weight for gestational
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Hellerstedt, W. L., Pirie, P.L., & Alexander, G. R_ ( 1995). Adolescent parity and infant
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Hemminki, E., & Gissler, M. (1996). Births by younger and older mothers in a population
with late and regulated childbearing. Finland 1991. Acta Obstet Gynecol Scand.
75, 19-27.
Herrmann, N. (1985). Retrospective information from questionnaires. II. Intrarater
reliability and comparison of questionnaire types. American Journal of
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Hickey, C. A., Cliver, S. P., Goldenberg, R. L., McNeal, S. F., & Hoffman, H J. (1997).
Low prenatal weight gain among low-income women: What are the risk factors?
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Hillier, S. L. (1998, December). BV: Current epidemiology, ongoing research and
unknowns. Paper presented at the meeting of 1998 National STD Prevention
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Hillier, S. L. (1999, October). Bacterial vaginosis. Paper presented at the 1999 Annual
OB-GYN Update for Clinicians, Orlando, FL.
Hillier, S. L., Nugent, R. P., Eschenbach, D. A., Krohn, M. A., Gibbs, R. S., Martin,
D.H, Cotch, M. F., Edelman, R., Pastorek, J. G., Rao, A. V., McNellis, D.,
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Prematurity Study Group. (1995). Association between bacterial vaginosis and


LIST OF TABLES
Table page
1. Comparison of Low Birth Weight Rates: Florida and United
States, 1989-1997 26
2. Historical Milestones in the Recognition and Study of
Chlamydia trachomatis 28
3. List of all Variables Used in Analysis 84
4. Total Records Linked to the 1996 Birth and Fetal Death Records 108
5. Study Sample Records Linked to the 1996 Birth and Fetal 109
Death Records
6. Comparison of Select Demographic Variables Between Relational
Database and Study Sample 112
7. Comparison Between Relational Database and Study Sample of
Select Variables Used in Combination to Create
Independent Indicator Variables for the Logistic Modeling 117
8. Comparison Between Relational Database and Study Sample of
Records Identified for Use as the Dependent Indicator Variables 121
9. Comparison Between Relational Database and Study Sample
of Records Identified for Use as the Independent Indicator Variables 123
10. Unadjusted Odds Ratios for Low Birth Weight, Based on Bi-variate
Analysis of Independent Variables in the Study Sample 124
11. Unadjusted Odds Ratios for Term Low Birth Weight, Based
on Bi-variate Analysis of Independent Variables in the Study Sample 126
vii


143
OR 0.62, mother bom in another country
OR 0.58, mother not a high school graduate
Table 17. Adjusted Odds Ratios, Based on Logistic Regression, for Black Race.
Low Birth Weight
Variable
OR
95% Cl
p value
High school graduate not
0.58
0.46, 0.72
0.0000
Inadequate weight gain
2.27
1.83, 2.82
0.0000
Mom foreign bom
0.63
0.44, 0.88
0.0073
Mom LBW
1.58
1.18, 1.12
0.0023
Prior poor pregnancy outcome
2.27
1.80, 2.86
0.0000
Smoking from birth record
1.93
1.40, 2.67
0.0001
STDs, past or current
1.78
1.20, 2.65
0.0046
Term Low Birth Weight
Variable
OR
95% Cl
p value
Alcohol use from birth record
2.39
1.04, 5.49
0.0396
High school graduate not
0.57
0.40, 0.81
0.0016
Inadequate weight gain
2.46
1.75, 3.45
0.0000
Mom LBW
2.18
1.43, 3.34
0.0003
Prior poor pregnancy outcome
2.09
1.45, 3.01
0.0001
Smoking from birth record
2.43
1.48, 4.01
0.0005
STDs, past or current
2.24
1.24, 4.04
0.0073
Pre-Term Low Birth Weight
Variable
OR
95% Cl
p value
High school graduate not
0.58
0.43, 0.77
0.0002
Inadequate weight gain
2.78
2.10,3.68
0.0000
Mom foreign bom
0.50
0.31, 0.81
0.0044
Prior poor pregnancy outcome
2.60
1.93, 3.49
0.0000
STDs, past or current
1.72
1.03, 2.86
0.0383


25
cervical chlamydia. This was more than five time the attributable risk from genital ulcer
disease in this group.
In summary Chlamydia trachomatis is associated with a profound scope of disease
manifestation in the reproductive age woman. These processes range from mildly annoying
symptoms to life threatening events. When pregnant women are infected with this bacteria
the sequelae may range from spontaneous abortion, premature rupture of membranes, pre
term labor to vertical transmission that results in low birth weight, stillbirth, and infantile
pulmonary infections that may cause lifelong damage to the infants respiratory system.
The full impact of this sexually transmitted infection remains to be established.
Epidemiology and Prevalence of Low Birth Weight
The Florida Office of Vital Statistics reported the rate of low birth weight was
8.5% in 1970 and dropped to 7.5% in 1980 (Office of Vital Statistics, 1996a). Between
the years from 1985 to 1995 the LBW rate hovered between 7.4% and 7.8%. From 1996
there has been a gradual upward shift to 8.1% total LBW for 1998, with an incrementally
upward change also for very low birth weight (VLBW) over the same period (Office of
Vital Statistics, 1999). The observations about rates in Florida mirror the gradual upward
shift in percentage of low birth weight reported nationally. However the national rates for
1998 are not yet available for comparison. Overall the percent of VLBW and total low
birth weight is higher in Florida than for the United States over the period of time
presented in Table 1 below.
Nationally the percentage of low birth weight for singletons among Hispanic
women has changed very little since 1989 at 5.35% to 1997 at 5.43.% The rate among


BIOGRAPHICAL SKETCH
Karla Schmitt is a nursing consultant with the Florida Department of Health,
Bureau of STD Prevention and Control. Primary responsibilities include coordination of
the Florida Chlamydia and Infertility Prevention Project, Integrated Surveillance Project
and Prevalence Studies. Additional responsibilities include development of clinician
resources; sexually transmitted infection training courses; and policies, technical
guidelines, and protocols applicable to delivery of public health care for sexually
transmitted infections. Her previous experience with the Department includes development
of family planning policies, implementation of Norplant and Depo-provera programs
statewide and the supervision of work directed toward the promotion of building an
integrated comprehensive health care system throughout the county health departments.
She has also worked as a nurse in home health care, on-call staffing, cancer chemotherapy,
and geriatric intermediate care. For many years, Ms. Schmitt worked in Belize, Central
America, delivering public health maternal and child health services to indigenous and
refugee populations. She is a member of the Florida Nurses Association, Florida Public
Health Association, and American Sexually Transmitted Disease Association. She received
a Bachelor of Science in Nursing in 1971 from Marquette University in Milwaukee,
Wisconsin, a Master of Public Health, international health management in 1993 from the
University of South Florida, and Master of Science in Nursing, in 1997 from the
University of Florida. She is a womens health nurse practitioner.
235


67
record file, is an extraction from this vital statistics database. The fetal death records were
also extracted from the vital statistics database. Some of the information regarding birth
and death records is similar, and some aspects are dissimilar. The following discussion will
note where they are similar and where they are different.
The registration of births and fetal deaths is both a local and state function of 67
local registration districts corresponding to the jurisdictional area of the county health
department. (Office of Vital Statistics, 1996b). The county health department director or
administrator serves as local registrar for that county. It is his/her responsibility to oversee
the timely and complete registration of births and deaths occurring in their district. Once a
birth or death event is accepted for registration, the local registrar maintains a copy of the
vital record and forwards the original to the state office.
The information contained in the vital birth and death record is obtained from the
following sources: mother, father, relatives or persons who have knowledge of the facts,
physicians, midwives, funeral directors, and hospital records. A standard form is used to
record and register the information required by the vital statistics law, Chapter 382,
Florida Statutes. The registration form in use during 1996 reflects the national model birth
record (Office of Vital Statistics, 1996b). The Florida birth registration form supports
collection of all recommended data from the model birth record, with the notable
exception of parental occupation. The hospital administrator (or if the birth is non-
institutional, the birth attendant) is required to file within five days after the birth a
complete and accurate birth certificate with the local registrar. The certificate must be
signed by at least one parent, attesting to the accuracy of the information, and either the
hospital administrator or designee, or birth attendant for non-institutional births. Chapter


CHAPTERS
DISCUSSION AND RECOMMENDATIONS
The purpose of this study was to examine, using a larger sample size, the research
question originally posed in a pilot study conducted by this investigator and colleagues in
1997, of 2,885 birth records and Chlamydia trachomatis test results. The present larger
study, with 191,988 birth and fetal death records, was designed to examine potential
associations between Chlamydia trachomatis and low birth weight outcomes among a
population-based sample of pregnant women and adolescents, who initiated prenatal care
through county health departments.
Additional variables were sought for the present study to better control for
confounding risk factors. A relational database was constructed that linked birth and fetal
death records, Healthy Start prenatal screens, maternal and infant sexually transmitted
case morbidity, maternal and infant laboratory test results, and congenital syphilis case
records. In this chapter, an analysis of the study question and other findings of interest,
implications for clinical practice, implications for public health policy, and suggestions for
fixture research will be discussed.
157


ACKNOWLEDGMENTS
I would like to thank my committee chair, Dr. Sharleen Simpson, who for the
duration of several years and from great distances has been a mentor and provided
generous guidance. And each of my committee members, Dr. Charles Mahan, Dr. Donna
Treloar, Dr. Lois Malasanos and Dr. James Stansbury, the contribution of their expertise
and, most notably, their consistent availability for consultation.
I would like to acknowledge with appreciation the following individuals whose
contributions have been significant and without whom this study would not have
happened! The relational database was prepared through the assistance and many hours
contributed by Alwin Chang, Ken Kampert, Melodee Dew and Karen Freeman. Dan
Thompson provided generous time and support to all steps of the statistical analyses. Phil
Moncrief provided willing guidance on my intepretation of the case morbidity system and
syphilis findings. The patient teaching of many colleagues strengthened the scope of
content contained in this work. The extensive assistance of Deberah Keith provided
organization to my wandering path on countless occasions. Jack Wroten encouraged my
professional growth and achievement through his exemplary leadership, and allowed me
the opportunity to explore a topic of enduring interest.
Finally, I would like to thank my family and friends for their loving support words
of encouragement, tolerance, nourishing meals and many spontaneous acts of kindness.
IV


150
The chlamydial infection indicator was eliminated at the 2nd step due to low
significance (OR .9535, p-vahie .9416, 95% Cl .2671, 3.4039) and the gonorrheal
infection indicator was eliminated at the 15th step (OR 2.33, p-value .0827, 95% Cl .8963,
6.0566). Pregnant women in the low birth weight adequate weight gain sub-sample
exhibited a substantially higher risk for low birth weight associated with the following
independent variables:
OR 2.33, mother was of black race
OR 1.87, identified as having smoked at any time during
OR 1.71, a history of a prior poor pregnancy outcome
OR 1.43, age less than 18 years or more than 40 years
OR 1.32, a history of medical conditions during pregnancy
In this model women reporting a mistimed pregnancy were 20% less likely to
experience a low birth weight event.
Logistic Model Six: All CHD with race indicator and adequate weight gain term
low birth weight. Due to missing data 377 cases were rejected and 10,525 remained in this
sub-sample analysis that is terminated after the 13th step. The chlamydial infection
indicator was eliminated at the 3rd step and the overall STD indicator at the 10th step. Of
interest is that gonorrheal infection was identified as significantly associated with term low
birth weight, however, with a rather wide confidence interval. (Please refer to Table 19.)
OR 2.33, a history of gonorrheal infection
OR 2.19, identified as having smoked at any time during pregnancy
OR 2.07, mother was of black race
OR 1.63, used drugs or alcohol in the last two prior to HS screen


164
The trae efficacy of different antibiotics used to treat chlamydia and other STDs
during pregnancy is unknown, little evidence exists in the literature that any of the
currently recommended treatments have been researched in controlled clinical trials among
non-pregnant females, and even less in pregnant females. These studies often used tests
with low sensitivity, and did not examine drag absorption or pharmokinetics
simultaneously (Bush, 1994; Turrentine, Troyer, & Gonik, 1994). Earlier work by
researchers has suggested that treatment of chlamydial (and other) infections in pregnancy
has reduced low birth weight rates in the populations studied (Hillier et aL, 1995;
McCormick, 1987; McGregor et aL, 1997; Schachter et aL, 1986; Hauth, Goldenberg,
Andrews, Dubard, & Copper, 1995). However, again these studies often used tests with
low sensitivity, and did not examine drag absorption or pharmokinetics simultaneously.
Information exists concerning altered pharmocokinetics in pregnancy leading to
physiologic changes in absorption, distribution, hepatic metabolism, renal elimination, and
transplacental passage of some drags (Dashe & Gilstrap, 1997). For example, increases in
blood volume and creatinine clearance lead to lower serum concentrations of many
antibiotics. Clearance of cephalosorins appears to be increased during pregnancy, probably
due to increased renal blood flow and decreased protein binding (Meyer, 1995).
Ceftriaxone has a shorter half-life in pregnancy, yet ceftriaxone, a third generation
cephalosorin is the drag of choice for gonorrhea. It is prescribed at one universal dosing
level according to national guidelines regardless of pregnancy status (Dashe & Gilstrap,
1997; CDC, 1998b). Gonorrhea untreated in pregnancy, can cause serious complications
for both the mother and the infant^ including markedly increased risks of disseminated
infection and preterm birth.


118
Table 7. Continued.
Relational Database
Study Sample
Births
190,497
13,914
Fetal Deaths
L501
88
Totals
191,998
14,002
#
%
#
%
Alcohol/drugs/tobacco use
Alcohol birth record
1,700
0.9
158
1.1
Alcohol healthy start
11,933
10.4
1,910
13.6
Tobacco birth record
23,524
12.3
2,871
20.5
Tobacco healthy start
19,401
10.1
4,114
29.4
Sexually transmitted infections2
Mom chlamydia positive test
437
0.2276
285
2.0354
Mom gonorrhea positive test
103
0.0537
51
0.3642
Mom pelvic inflammatory disease
16
0.1536
3
0.0214
Mom all syphilis
295
0.0015
35
0.2500
Mom herpes
2,396
1.2479
96
0.6856
Infant chlamydia positive test
1
0.0005
-
-
Infant chlamydia opthalmia
37
0.0193
5
0.0357
Infant gonorrhea opthalmia
4
0.0021
-
-
Infant chlamydia pneumonia
2
0.0010
1
0.0071
Infant congenital svphilis
67
0.0349
5
0.0357
1 Some variable values do not total to 100% due to missing values in records.
2 These variables at four decimal places to better illustrate that the event did occur.
In contrast, more than half as many in the study sample were of normal body mass index.
Twenty eight percent of the study sample were of high or obese body mass index and
sixty-one percent less were calculated to have an obese body mass index. Twenty four
percent of black women were underweight in the study sample compared to 27.5% of
white women (data not shown). One third again as many black women (21.2%) were
obese as white women (14.7%). Both race/ethnicity groups were similarly distributed for


76
prior to entry of the test results. During the course of testing the test results are verified
and any applicable qualifiers or specimen rejections are entered into the system, along with
the names of those reporting the results. Data error can and does occur at the initial phase
of specimen and demographic registration into laboratory computer systems. Daily quality
assurance activities monitor data entry of demographic information and the reporting of
test results.
During 1998, an unfortunate series of events occurred that caused corruption of
segments of the database affecting calendar years 1996 and 1997. While much of the
primary database was subsequently repaired from archival tapes, not all of 1996 or 1997
test reports could be restored. Hard copy requisition slips are maintained in archival files
for the seven-year time period as required for medical records by law, Chapter
483.05 l(7Xf), Florida Statutes. The extent and the scope of the damage to the electronic
operating system and hardware was not identified until many months after this study was
conceptualized, the protocols written and approved, and countless hours expended on
matching of records to the base study file had commenced. Hence it was impractical at
that point to consider re-framing the study around a different birth cohort. Unfortunately,
these records are stored according to specimen ascension number. The estimated cost for
retrieval of missing test results for subsequent re-entry into the data system would serve
no laboratory purpose and was cost prohibitive to this investigator in terms of the study
budget. There is no reason to believe that the individual test reports contained in the Gen-
Probe test report data set are any more or less complete in any given time segment for the
period included in this study. There is reason, however, to believe that the distribution of
the test reports is constrained by both the events associated with the implementation of the


22
clinicians would prefer not to suggest to parent(s) that a newborn infant be tested for a
sexually transmitted disease. Accordingly many will empirically treat infants exhibiting
suggestive symptoms with antibiotic ointments, without collecting a specimen.
Consequently there are no positive test results reported to authorities. No comprehensive
review of all causes of neonatal opthalmia and pneumonia has been conducted nationally
or in Florida in recent years. In one study conducted in Florida the authors identified a
higher association between gonorrheal opthalmia with hospitals using eyrthromycin for
ocular prophylaxis (Desenclos, Garrity, Scaggs, & Wroten, 1992).
Infants may also present with pneumonia, following intra-partum exposure to
Chlamydia trachomatis (Stamm & Holmes, 1990; Freund, 1992). Chlamydial pneumonia
is a far more serious disease sequelae in this country than is conjunctivitis. Often infants
may continue to have reduced pulmonary capacity well into childhood. This is
demonstrated by abnormal pulmonary function tests and obstructive lung disease as
identified in the study by Weiss et aL, 1986 (as cited in Hammerschlag, 1999). Between 8
to 22% of infants bom to infected mothers will develop pneumonia (Harrison &
Alexander, 1990; Crombleholme, 1991). Chlamydial pneumonia presents with a repetitive
staccato cough accompanied by tachypnea. Hyperinflation and diffuse infiltrates are noted
on chest x-ray. Fever and wheezing are uncommon. Reliable diagnosis is a more invasive
affair than testing for ocular infection, with tracheal aspirates and tissue culture more
sensitive and specific than nasopharygeal specimens for non-culture testing. Effective
treatment often requires a second course of the recommended antibiotic therapy, due to
only 80% efficacy of the recommended eyrthromycin (CDC, 1998a).


77
computer system and the described corruption event that occurred. The skewed
distribution is discussed below in the results chapter. However, one of the strengths of this
data set is the representiveness of specimens collected from women receiving prenatal care
in county health departments.
In the initial step, an extraction using MUMPS was made from the primary
laboratory data system to select data fields with information pertaining to Gen-Probe
PACE2C (S. Shiver, personal communication, June 30,1999). This extraction was done
through the use of programming with Visual Basic to create a database flat file. The files
were then transferred onto the Sequel Server subdirectory. (The NT platform operating
system replaced the Unix system in late 1998 following the discovery of the system
failure.) The files were then accessible through the closed-frame relay departmental wide-
area network to the Bureau of STD staff with appropriate authorization and passwords.
At the next step FOX PRO programming software was used to construct an ASCI flat file
extracting only the desired study variables. In this step some variable fields were made to
conform to numeric codes consistent with the base study file, the 1996 Birth Fetal Death
Records, (race, ethnicity, county), and the Year 2000 date format (YYYYMMDD).
Extraction parameters included: all Gen-Probe PACE2C reports with collection date
between March 1995 through June 1997, for females regardless of date of birth, and
reports for males with a date of birth during 1996. The following variables were extracted
to support the matching process and for subsequent descriptive analysis: last name, first
name, social security number, date of birth, race, sex, address, county, specimen number,
date of specimen collection, test type, and results for both Chlamydia trachomatis and
Neisseria gonorrheae. The extraction totaled 214,121 records from the primary laboratory


100
Assumptions
The reliability of information contained in the birth record files has been discussed
in the literature (Buescher, Taylor, Davis., & Bowling, 1993). The investigator had no
reason to assume that the completion accuracy of the records used in this study would be
any less than that of other records not selected in the matching process.
Limitations of the Study Design and Methodology
This study had three primary limitations. The sample population, while
representative of pregnant women attending county health departments in Florida, may not
be representative of all pregnant women who delivered in the state during the study
period. The county health departments enrolled 30,234 women into prenatal care during
1996. However, not all would have delivered during the calendar year, and some would
have experienced a pregnancy or fetal loss as well This number represents 15.7% of all
births and fetal deaths recorded in the state during that same year. The study sample
examined extracted the records of 14,002 women who initiated their prenatal care through
the county health department for the logistic regression modeling. The number may
represent approximately half of those who were provided prenatal care in the county
health departments during that time period. The rate of first trimester entry was very
similar for both groups of county health department women (62.8% during the calendar
year and 61.4% for the study sample). The power of some independent variables was
limited by the sample size, e.g., chlamydial and gonorrheal infection.
The second significant limitation was loss of data and, consequently, potential
strength of the laboratory test variable, through the loss of months of information from the


207
Singh, V., Gupta, M. M., Satyanarayana, L., Parashari, A., Sehgal, A., Chattopadhya, D.,
& Sodhani, P. (1995). Association between reproductive tract infections and
cervical inflammatory epithelial changes. Sexually Transmitted Diseases. 22(1). 25-
30.
Smith, J. W., Rogers, R.E., Katz, B. P., Brickler, J. F., Lineback, P. L., Van der Pol, B.,
& Jones, R. B. (1987). Diagnosis of chlamydial infection in women attending
antenatal and gynecologic clinics. Journal of Clinical Microbiology. 25(5). 868-
872.
Sozio, J., &Ness, R. B. (1998). Chlamydial lower tract infection and spontaneous
abortion. Infectious Diseases in Obstetrics and Gynecology. 6. 8-12.
Spinillo, A., Capzzo, E., Baharo, F., Piazzi, G., Nicola, S., & Iasci, A. (1996). The effect
of work activity in pregnancy on the risk of fetal growth retardation. ACTA
Obsttrica et Gvnecologica Scandinavica 75. 531-536.
SPSS Inc. (1999). Statistical package for social sciences, version 9,0. Chicago, IL: SPSS
Inc.
Stagno, S., & Whitley, R. J. (1999). Herpesvirus infections in neonates and children:
Cytomegalovirus and herpes simplex virus. In K.K. Holmes, P. F. Sparling, P. A.
Mardh, S. M. Lemon, W. E. Stamm, P. Piot & J. M. Wasserheit, (Eds.), Sexually
transmitted diseases (3rd ed.. pp. 1191-1212). New York: McGraw-Hill, Inc.
Stamm, W. E. (1988). Diagnosis of Chlamydia trachomatis genitourinary infections.
Annals of Internal Medicine. 108(51. 710-717.
Stamm, W. E. (1999). Chlamydia trachomatis infections of the adult. In RR Holmes, P.
F. Sparling, P. A Mardh, S. M. Lemon, W. E. Stamm, P. Piot & J. M. Wasserheit,
(Eds.), Sexually transmitted diseases (3rd ed., pp. 407-422). New York: McGraw-
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Stamm, W. E. & Holmes, K. K (1990). Chlamydia trachomatis infections of the adult. In
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New York, NY: McGraw-Hill, Inc.
Steele, J. A (1995). Intendedness of pregnancy: State level assessment Unpublished
manuscript, Florida State University, Tallahassee.
Steiner, C. (1989). Cervical cancer screening from the public health perspective. Acta
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153
Other Related Study Findings of Interest
Insufficient literature has been published on the associations between sexually
transmitted infections, low birth weight and other adverse pregnancy outcomes. No study
published has controlled for each sexually transmitted infection, along with the many risks
known to be significantly associated with low birth weight, and other adverse pregnancy
outcomes, and also used highly sensitive laboratory tests prospectively in a controlled
study to specifically examine the associations. This study was not explicitly designed to
look at the role of other STDs and pregnancy outcomes. However, some data and their
descriptive analysis within the context of this study merit further discussion.
Within the larger relational database, 427 case infant and maternal morbidity files
were linked to birth and fetal death records. Additionally, other cases of sexually
transmitted diseases were identified from the maternal and infant laboratory test records.
Among those infected with either chlamydia or gonorrhea, no fetal death records were
linked. Nine maternal morbidity cases were linked to fetal death records, all of which were
of normal birth weight. Linkages between the laboratory tests included 437 chlamydia
cases and 103 gonorrhea cases with live birth records. Very few of the women with
positive laboratory tests were matched with the same infant who had a positive laboratory
test linked to their record. Of the 67 linked congenital syphilis cases, 14 were either term
or pre-term low birth weight (20.8%). Only 40 of the 67 congenital cases were matched to
mothers identified as having a diagnosis of syphilis within the context of the relational
database, 39% of which were to latent syphilis cases.
Among the study sample, all but two of the 35 matched maternal syphilis cases
were reported as latent syphilis. This grouping included those with early latent syphlis and


190
Fang, J., Madhavan, S., & Alderman, M. FL (1999). Low birth weight: Race and maternal
nativity impact of community income. [Abstract] Pediatrics. 1030). 142.
Farthing, P., Brumback, B., Morris, M., & Wright, M. (1995, May). Confirmation of
positive Chlamydia trachomatis results using the DNA Probe competition assay.
Poster session presented at the American Society of Microbiology Meeting,
Washington, DC.
Feamside, F. J. (1916). State board of health: 27th annual report. State Board of Health.
Palatka, FL: Palatka News.
Fedorko, D. P., & Smith, T. F. (1991). Chlamydial infections. In B. B. Wentworth, F. N.
Judson, & M. J. R. Gilchrist. (Eds.) Laboratory methods for diagnosis of sexually
transmitted diseases. (2nd ed., pp. 95-125). Washington, DC: American Public
Health Association.
Fejgin, M. D., Cohen, L, Horvat-Kohlmann, M., Charles, A. G., Luzon, A_, & Samra, Z.
(1997). Chlamydia trachomatis infection during pregnancy: Can it cause
intrauterine infection? Israeli Journal of Medical Sciences. 33(2). 98-102.
Available: www.ncbLnlm.nih.gov.
Florida Department of Health. (1997a). Florida Morbidity Statistics. 1996. Tallahassee:
Author.
Florida Department of Health. (1997b). Healthy start annual report. 1997. Tallahassee:
Author.
Florida Department of Health. (1997c). Intervention update. Special edition: Chlamydia.
Tallahassee: Author.
Florida Department of Health. (1999). STD morbidity case reports 1998. Tallahassee.
Author.
Florida Department of Health (1998). Healthy start: Standards and guidelines, 1998.
Tallahassee: Author.
Florida Department of Health and Rehabilitative Services. (1995). Floridas healthy start:
1994-95 annual report. Tallahassee: Author.
Florida Department of Health (1999). Florida WIC nutrition risk criteria: Interpretive
guidelines. Bureau of WIC and Nutrition Services: Tallahassee, FL.


31
is metabolically inactive and resistant to most environmental challenges, but capable of
rapid attachment to the host cell This attachment is generally held to be aided by some
mechanism that triggered adhesion with the assistance of the major outer membrane
protein, and generally was held to have occurred within an hour of infection. Newer
scientific knowledge suggests adhesion may instead be a parasite-specified phagocytosis,
receptor-mediated endocytosis in clarthrin-coated pits, pinocytosis in non-coated pits,
chlamydial heat shock protein70 interaction with ATP hydrolysis or movement assisted by
host microvilli (Raulston, Davis, Paul, & Wyrick, 1998; Patton, Cummings, Cosgrove,
Yvonne & Kuo, 1998; Wentworth, Judson, & Gilchrist, 1991). Most noteworthy is the
sheer speed with which the EB can enter the host. Electron microscope observation of the
in vivo uptake process has recently demonstrated that the EB are assisted by the
epithelial cells microvilli and that internalization is complete within five minutes, and has
reached the Golgi apparatus within ten minutes post infection (Patton et al, 1998). This
group of researchers suggests that the rapid uptake reflects the bacterias need to reach
the host energy source, as it is incapable of producing energy on its own. Once inside the
host cell, a vacuole is formed to envelop the EB, where the EB remain throughout the
growth cycle. After a rapid initial fluctuation in pH, a triggered release of tyrosine
phosphoylation of the epithelial proteins follows and rearrangement of the chlamydiaes
cytoskeleton occurs. There is then an accumulation of F-actin and clathrin which it is
believed, aids to redistribute the EB to the peri-nuclear region of the host cell and the
resultant highly permeable vacuole formation (Wyrick, 1998; Schatcher, 1999a; Schatcher,
1995). The vacuole becomes what microbiologists term the chlamydial inclusion body.
At this point the chlamydiae prime their host for obligate intracellular


199
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mimics that of the euraryotic cell [Abstract]. In R. S. Stephens, G. I. Byrne, G.
Christiansen, L N. Clarke, J. T. Grayston, R. G. Rank, G. L. Ridgeway, P. Saikku,
J. Schachter, & W. E. Stamm (Eds.), Chlamydial Infections: Proceeding of the
Ninth International Symposium on Human Chlamydial Infection (pp. 95-98). San
Francisco, CA: International Chlamydia Symposium.
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(1987). Effect on birth weight of erythromycin treatment of pregnant women.
Obstetrics and Gynecology. 69(21. 202-207.
McGregor, J. A., & French, J. I. (1991). Chlamydia trachomatis infection during
pregnancy. American Journal of Obstetrics and Gynecology', 164 6-P2). 1782-
1788.
McGregor, J. A., & French, J. I. (1997). Pathogenesis to treatment: Preventing preterm
birth mediated by infection. Infectious Diseases in Obstetrics Gynecology. 5. 106-
114.
McGregor, J. A, French, J. L, Parker, R., Draper, D., Patterson, E., Jones, W.,
Thorsgard, K_, & McFee, J. (1997). Prevention of premature birth by screening
and treatment for common genital tract infections: Results of a prospective
controlled evaluation. American Journal of Obstetrics and Gynecology. 173(1).
157-167.
Mertz, K. J., McQuillan, G. M., Levine, W. C., CandaL D. FL, Bullard, J. C., Johnson, R.
E., St. Louis, M. E., & Black, C. M. (1998). A pilot study of the prevalence of
chlamydia infection in a national household survey. Sexually Transmitted Diseases.
25(7), 225-228.
Meyer, J. M. (1995). Antimicrobials during pregnancy. Infections in Medicine. 9. 420-
425,453.
Microsoft. (1997). ACCESS users guide. Redmond, WA: Author.
Mittendorf R., Herschel, M., Williams, M. A, Hibbard, J. U., Moawad, A R, & Lee, K.
(1994). Reducing the frequency of low birth weight in the United States.
Obstetrics and Gynecology, 83. 1056-59.
Moneada, J., Schachter, J., Shipp, M., Boln, G., & Wilber, J. (1989). Cytobrush in
collection of cervical specimens for detection of Chlamydia trachomatis. Journal
of Clinical Microbiology. 27. 1863-1866.


181
gestational weight gain? In future years, an analysis comparing sub-samples of births and
fetal death records for adolescent and young adults infected with sexually transmitted
infections, would provide an opportunity to explore more fully a group at high risk for
STD related adverse outcomes, and other socially related events.
The many statistically significant findings from this study suggest the need to
examine a much larger sample to better understand the association between chlamydia,
gonorrhea, and syphilis infection and low birth weight. A large multi-centered, and multi
disciplinary randomized prospective, designed to examine the contributory role of each
STD while controlling for the others, would be invaluable if highly sensitive tests and all
infections were included. Ideally, such a study would also control for the many low birth
weight risks examined in this study, as well as other behavior risk factors not available
within the present relational database. It would also include the diverse professional
perspectives of laboratorians, advanced practice nurses, physicians, and biologists,
utilizing both quantitative and qualitative analyses to more fully examine the associations
between low birth weight, chlamydia and other sexually transmitted infections. There is
clearly a need to better understand the pathogenesis of Chlamydia trachomatis in
pregnancy to effectively intervene in the process.


224
if (MHF4 eq 13) poorouti=l.
if(MHF5 eq 13) poorouti=l.
if (MHF6 eq 13) poorouti=l.
missing values poorouti (-1).
FORMATS poorouti (F8).
VARIABLE LABELS poorouti "prior poor pregnancy outcome indicator".
VALUE LABELS poorouti
.000000000000000 "prior pregnancy ok"
1.00000000000000 "prior poor pregnancy outcome
FREQUENCIES
VARIABLE S=poorouti
/ORDER ANALYSIS .
To create the mom LBW at her birth indicator variable
compute momLBW=0.
if (LBWATB =V) momLBW=l.
if (LBW AT B =TST) momLBW=0.
missing values mornLBW (-1).
FORMATS mornLBW (F8).
VARIABLE LABELS mornLBW "mom was LBW at birth".
VALUE LABELS mornLBW
.000000000000000 "mom not LBW at birth"
1.00000000000000 "mom was LBW at birth


CHAPTER 4
RESULTS
In this chapter the results of linking the respective databases, the descriptive
analyses, results of research questions, and statistical significance of the findings will be
presented. Some additional unanticipated findings of interest will be presented at the close.
Results of I .inking the Respective Databases
The original study design included all of those data sets included in the present
analysis: birth and fetal death records, Healthy Start prenatal screen, maternal and infant
sexually transmitted case morbidity, and maternal and infant chlamydia laboratory test
results. The study would also have included the following: 1) geocoding of records by
census tract and income from the 1990 United States Census; 2) county health department
service codes; and 3) Medicaid service and pharmacy records. Many individuals
contributed extensive hours over the course of two years to clean and prepare the files for
linkage within this relational database. Each step of the file preparation, matching
processes, and quality assurance checks required more time than anticipated or scheduled
for in the study timeline. Due to study completion time constraints, it was decided to
conduct the analyses without the development of those linkages that were still pending by
July 1999, or the information that those data sets contained. The final three components
104


119
normal body mass index (whites 47.5% and blacks 45.4%). Ten percent of white women
and 13% of black women were ofhigh body mass index.
Life stressors were among the questions used to solicit information about the level
of stress and psychosocial problems in womens lives. Those in the study sample reported
life stressors at a significantly higher rate than those in the general population. Please refer
to Table 7. The only exception to this question was a medium stress level reported more
than three times more frequently among the larger group that delivered during 1996.
The reported use of alcohol as recorded from the birth record, was very low and
similar to the percent in the study sample. In contrast, alcohol/drug use from the Healthy
Start field was reported about one third more often among women in the study sample. It
is difficult to compare these two fields and make any inference regarding validity about the
marked difference due to the different way in which the question is posed. Please refer to
Table 7. On the birth and fetal death certificate, the mother is asked if she used alcohol
during this pregnancy. In the Healthy Start prenatal screen encounter, the question asked
is: In the last two months, have you used drugs or alcohol? (including beer, wine, mixed
drinks). While any comparison regarding these two database fields is problematic, the ten
fold difference suggests one of them is very unreliable and is subject to both recall bias and
the skills of health care providers to elicit complete alcohol and drug use histories. It is
unlikely that only among women who received a Healthy Start prenatal screen have
alcohol and drug use associated with pregnancy. Tobacco use based on the Healthy Start
prenatal screen variable was higher in both groups than for the same group from the birth
record, and twice as much in the study sample. (Again this field is omitted from the fetal
death record.)


160
risk in this study for a pre-term low birth weight was significantly higher for women with
inadequate weight gain. The initial four logistic models identified associations between
low birth weight and select risk factors.
Analysis suggested that inadequate and adequate weight gain contributed a strong
confounding influence. Once this was controlled for, different patterns of associations
were observed. Of particular interest was the regrouping of independent variables.
Maternal age, black race, smoking, use of alcohol, and gonorrhea infection increased the
likelihood of different levels of low birth weight among women with adequate weight gain
(OR 1.43, 2.33, 1.87,1.63, and 5.11, respectively). Among women with inadequate weight
gain, infection with chlamydia was found to be statistically significantly associated with the
dependent variables (OR 1.98 for LBW, and 2.34 for PTLBW). Other factors that
contributed to increased likelihood of low birth weight events among women with
inadequate weight gain, were use of alcohol (OR 2.36), prior poor pregnancy outcomes
(OR 1.96), smoking (OR 1.76), black race/ethnicity (1.51), and not being married (OR
1.37). Other researchers, who have reported their work in the literature, have not reported
these same patterns of association, perhaps due to the more limited numbers of variables
included in other studies. Controlling for level of weight gain increased the significance of
chlamydia infection, gonorrhea and a history of other sexaully transmitted infections.
The pathogenesis of chlamydial infection in pregnancy and low birth weight is not
well understood. Three models were discussed in Chapter 2: 1) delayed-type
hypersensitivity, 2) inflammatory response mediated by human-heat shock proteins and
chlamydial heat shock proteins, and 3) genetic susceptibility (Chlamydia Genome Project,
1999). Two 1996 studies of the immune consequences of Chlamydia trachomatis have


46
Standards on Gen-Probe PACE2C Testing Technique; Within Florida
Testing standards in the Office of Laboratory Services require that all female
specimens are first screened with the PACE2C System, a combination chlamydial and
gonococcal nucleic acid hybridization technique. The combination assay allows rapid dual
screening for the presence of either Chlamydia trachomatis or Neisseria gonorrhea.
While this first assay does not distinguish between which organisms are present, it is a
cost-effective labor reducing approach in populations with lower prevalence, e.g., prenatal
clinics compared to STD clinics (Hale, Melton, Pawlowicz, Halstead, & Wright, 1995).
All specimens screening positive for the presence of an infection are then re-tested using
both the PACE2 Chlamydia and PACE2 Gonorrhea assays. Additionally, all high negative
specimens and low positive specimens are re-screened (Farthing, Brumback, Morris, &
Wright, 1995). This involves a two step process. The first is a repeat of the PACE2 assay
utilizing the chemiluminescent labeled DNA probe specific first for chlamydia, followed by
that for gonorrhea. Next the specimen is tested using the Probe Competition Assay (PCA)
with reagents that will compete for the target binding sites to form stable DNA-RNA
hybrids. A reduction in the signal generated will indicate the specimen contains Chlamydia
trachomatis or Neisseria gonorrhea rRNA contingent on the assay used (Gen-Probe
Incorporated, 1994a). The PCA functions as a confirmatory test for questionable results as
well as a percentage of all positive findings, an appropriate standard when misdiagnosis of
either sexually transmitted infection could lead to psychological anguish or legal
ramifications for the patient and/or their partner. Those specimens that originally tested as
high negative or low positives but on retesting tested positive or negative respectively, are


201
National Chlamydia Committee. (1999hY Specimen inhibitors of amplification in DNA
amplification assays for Chlamydia trachomatis. Paper submitted for review.
Neeper, I. D., Patton, D. L., & Kuo, C. C. (1990). Cinematographic observations of
growth cycles of Chlamydia trachomatis in primary cultures of human amniotic
cells. Infection and Immunity. 58. 2042-2047.
Nesbitt, T. S., Larson, E. H., Rosenblatt, R A., & Hart, L. G. (1997). Access to maternity
care in rural Washington: Its effects on neonatal outcomes and resource use.
American Journal of Public Health. 87(1). 85-90.
Neuer, A, Ruck, P., Marzusch, K, Dietl, J., Kaiserling, E., Homy, H-P., & Witkin, S. S.
(1996). Human heat shock proteins in first trimester human decidua [Abstract],
Presented at International Symposium on Immunopathogenesis of Chlamydia
Infections, New York, NY. Infectious Diseases in Obstetrics and Gynecology. 4.
188-189.
Newhall, W. J., Johnson, R E., Delisle, S., Fine, D., Hadgu, A., Matsuda, B., Osmond,
D., Campbell, J., & Stamm, W. E. (1999). Head-to-head evaluation of five
chlamydia tests relative to a quality-assured culture standard. Journal of Clinical
Microbiology. 3713). 681-685.
Numazaki, K. (1998). Serologic tests for Chlamydia trachomatis infections: Letter.
Clinical Microbiology Reviews. 11(1). 228-229.
Numazaki, K, & Chiba, S. (1996). Serum gamma-interferon in patients with pnuemonia
caused by Chlamydia pneumoniae. The Pediatric Infectious Disease Journal.
15(2), 174-175.
Numazaki, K, Kusaka, T., & Chiba, S. (1996). Perinatal complications are associated
with seropositivity during Chlamydia trachomatis during pregnancy. [Abstract!,
Clinical Infectious Diseases. 23. 208.
Office of Vital Statistics (1996a). Florida vital statistics annual report, 1995. Jacksonville,
FL: Author.
Office of Vital Statistics. (1996b). Vital records registration handbook: Birth edition
Jacksonville, FL: Author.
Office of Vital Statistics (1997). Florida vital statistics annual report, 1996. Jacksonville,
FL: Author.
Office of Vital Statistics (1999). Florida vital statistics annual report. 1998. Jacksonville,
FL: Author.


34
extracellular form of Chlamydia trachomatis is inhibited by penicillins, but is not killed. In
this form it is sensitive to temperature, freezing, and dessication. Unlike C. psittaci that
can live for months in contaminated cat litter, C. trachomatis will die at 56C after 30
minutes. C. trachomatis is also sensitive to common household disinfectants (Wyrick,
1998; Schachter, 1995; McCalarty & Hatch, 1998).
Pathophysiology and Pathogenesis
The clinical syndromes associated with Chlamydia trachomatis infection are well
recognized in the public health community. The pathogenesis of any of the infections
attributable to Chlamydia trachomatis is not well understood. Of the twenty-three
identified serovars, nine are predominant in the genital tract and in infantile pneumonia: D,
E, F, G, H, I, J, and K, with D, E, and F found most frequently worldwide. One, B, has
been identified in both ocular and genital sites (please refer to Figure 2.). Numerous
serovars and variants have only been identified in the last few years (Stephens et aL, 1998;
Stamm, 1999). Serovars in the C complex grouping (A, C, H, I, J, K) have been identified
as more likely to be associated with symptomatic rectal infection among homosexual
males (Boisvert, Koutsky, Suchland, & Stamm, 1999). It has been hypothesized that
severity of disease may be linked to the serovar. Some studies have supported this;
however, serovar F has often been identified in both less asymptomatic or less
inflammatory infection as well as in women with upper genital tract infection.
Squamocohimnar epithelial cells are the primary target for non-LGV infections and
macrophages for LGV serovars. Initially, focal inflammation with infiltration of
polymorphonuclear neutrophils occurs. Mononuclear cell infiltration follows. Abundant


226
To create a education indicator variable.
(this takes into account young age girls still in high school)
compute edindic=0.
if ((mage ge 18) and (med le 12 or med eq 99)) edindic=l.
missing values edindic (-1).
FORMATS edindic (F8).
VARIABLE LABELS edindic "education level indicator
VALUE LABELS edindic
.000000000000000 "HS grad or adequate for age"
1.00000000000000 "less than high school or indicated for age".
FREQUENCIES
VARIABLE S=edindic
/ORDER ANALYSIS .
To create a race indicator variable (black only).
compute raceindi=0.
if (MRACE eq 2) raceindi=l.
missing values raceindi (-1).
FORMATS raceindi (F8).
VARIABLE LABELS raceindi "black race indicator ".
VALUE LABELS raceindi
.000000000000000 "mom not black race"
1.00000000000000 "mom is black race".
FREQUENCIES
VARIABLE S=raceindi
/ORDER ANALYSIS .
To create an adequate wt gam indicator.
compute BMIG=0.
if (BMI le 19.79) BMIG=1.
if (BMI ge 19.80 and BMI le 26.00) BMIG=2.
if (BMI ge 26.01 and BMI le 29.00) BMI03.
if (BMI ge 29.01) BMIG=4.
missing values BMIG (-1).
FORMATS BMIG (F8).
VARIABLE LABELS BMIG "BMI groups.
VALUE LABELS BMIG
1.00000000000000 "BMI low < 19.79"
2.00000000000000 "BMI normal 19.80 to 26.00"
3.00000000000000 "BMI high 26.01 to 29.00"
4.00000000000000 "BMI obese > 29.01".
FREQUENCIES
VARIABLES^ BMIG
/HISTOGRAM NORMAL


19
The difficulty even in the existence of either epidemiologic or statistically
significant evidence for a relationship between chlamydial infection and adverse pregnancy
outcomes is that neither type of study has provided enough information about the
sequence of events. Therefore it is difficult to demonstrate a direct cause and effect
relationship between chlamydial infections and adverse pregnancy' outcomes. Additionally,
the variable signs, symptoms, test types, definitions of variables, timing of the specimen
collection during the pregnancy, and inclusion or exclusion of specimen collection to test
for other STDs reduces the value of prospective cohort studies conducted to explore the
associations between Chlamydia trachomatis and pregnancy outcomes.
In the United States Chlamydia trachomatis is primarily a sexually acquired genital
infection. However the infection is also a serious congenitally acquired infection. Risk of
any chlamydial infection among infants bom to infected women is estimated at 50% to
75%. Between 35% to 50% of infants bom to infected mothers will go on to develop
conjunctivitis and 8% to 22% will develop pneumonia (Harrison & Alexander, 1990;
Crombleholme, 1991). Initial perinatal infection involves mucous membranes of the eye,
oropharynx, urogenital tract, and the rectum (page 57, CDC, 1998b). The typical course
is inclusion conjunctivitis first noted at 5 to 12 days of age. If left untreated conjunctivitis
may result in comeal scarring and vascularization. It may also be aysmptomatic and self
limited (Schulz, Schulte, & Berman, 1992).
Among infants bom to infected mothers, 20% to 50% will develop conjunctivitis
and 10% to 20% will develop pneumonia and chlamydial respiratory disease syndrome,
with increased sensitization of the infant to further chlamydial infections (Datta et al,
1988; Schachter et aL, 1986). Schachter et aL (1986) reported sub-clinical rectal and


183
Augustyn, M., & Maiman, L. A. (1994). Psychological and sociological barriers to
prenatal care. Womens Health International 4(1). 20-28.
Baden, S. (1999, October). Region IV infertility prevention project data. Presentation at
Bi-Regional Chlamydia Advisory Board Meeting, Tampa, FL.
Barbeyrac, B. de, Rodriquez, P., Dutilh, B., le Roux, P., & Bebear, C. (1995). Detection
of Chlamydia trachomatis by ligase chain reaction compared with polymerase
chain reaction and cell culture in urogenital specimens. Genitourinary Medicine.
71, 382-386.
Batteiger, B. E., Fraiz, J., NewhalL W. J., Katz, B. P., & Jones, R B. (1989). Association
of recurrent chlamydial infection with gonorrhea. The Journal of Infectious
Diseases. 159(41. 661-668.
Bauman, B. J. (1993). Use of a cervical brush for Papanicolaou smear collection: A meta
analysis. Journal of Nurse-Midwifery, 38 (5), 267-275.
Beatty, W. L., Morrison, R P., & Byrne, G. I. (1994). Persistent chlamydiae: From cell
culture to a paradigm for chlamydia pathogenesis. Microbiological Reviews. 58(4).
686-699.
Beck-Sague, C. M., Cordts, J. R, Brown, K., Larsen, S. A., Black, C. M., Knapp, J. S.,
Ridderhof, J. C., Bames, F. G, & Morse, S. A. (1996). Laboratory diagnosis of
sexually transmitted diseases in facilities within the United States: Results of a
national study. Sexually Transmitted Diseases. 23(41. 342-349.
Bell, T. A., Stamm, W. E., Kuo, C-C., Wang, S-P., Holmes, K. K., & Grayston, J. T.
(1994). Risk of perinatal transmission of Chlamydia trachomatis by mode of
delivery. Journal of Infection 29 165-169.
Bellamy, H. (1998). Identifying common threads among Floridas fetal infant mortality
review projects: A workshop for FMTR projects and statewide systems partners.
Washington, DC, Health Systems Research, Inc.
Bergstrom, F., & Libombo, A. (1995). Low birthweight and post partum endometritis-
myometritis. Acta Obstetricia et Gvnecologica Scandinavica. 74. 611-613.
Berkowitz, G. S., Blackmore-Prince, C., Lapinski, R H, & Savitz, D. A. (1998). Risk
factors for preterm birth subtypes. Epidemiology. 9131. 279-285.
Berkowitz, G. S., & Marcus, M. (1992). Adolescence and pregnancy outcome. Annals of
Epidemiology, 2151. 755-757.


195
preterm delivery of a low-birth-weight infant. New England Journal Medicine. 333.
1737-1742.
Hillier, S. L., & Holmes, W. E. (1999). Bacterial vaginosis. In K.K Holmes, P. F.
Sparling, P. A. Mardh, S. M. Lemon, W. E. Stamm, P. Piot & J. M. Wasserheit,
(Eds.), Sexually transmitted diseases (3rd ed.. pp. 563-586). New York, NY:
McGraw-Hill, Inc.
Hillis, S. D., Joesoef R., Marchbanks, P. A., Wasserheit, J. N., Cates, W., & Westrom, L.
(1993). Delayed care of pelvic inflammatory disease as a risk factor for impaired
fertility American Journal of Obstetrics and Gynecology. 168(5). 1503-1509.
Hook, E. W. & Hansfield, H H. (1999). Gonoccoccal infection is the adult. In K.K.
Holmes, P. F. Sparling, P. A. Mardh, S. M. Lemon, W. E. Stamm, P. Piot & J. M.
Wasserheit, (Eds.), Sexually transmitted diseases (3rd ed., pp. 451-466). New
York, NY: McGraw-Hill, Inc.
Hulsey, T. C., Alexander, G. R_, & VanDorsten, P. (1998). Cause of preterm birth in
first and second deliveries. Prenatal and Neonatal Medicine. 3. 134-137.
Innes, K E., Marshall, J. A., Byers, T. E., & Calonge, N. (1999). A womane own birth
weight and gestational age predict her later risk of developing preeclampsia, a
precusor of chronic disease. Epidemiology. 10(2). 153-160.
Institute of Medicine. (1992). Nutrition services in perinatal care (2nd ed). Washington,
DC: National Academy Press.
Investigators of the Johns Hopkins Study of Cervicitis and Adverse Pregnancy Outcome.
(1989). Association of Chlamydia trachomatis and Mycoplasma hominis with
intrauterine growth retardation and preterm delivery. American Journal of
Epidemiology. 129161. 1247-1257.
Ismail, M. A., Pridjian, G., Hibbard, J. U., Harth, C., & Moawad, A. A. (1992).
Significance of positive cervical cultures for Chlamydia trachomatis in patients
with preterm premature rupture of membranes. American Journal of Perinatology.
9(5-6), 368-370.
Jancin. B. (1999). Chlamydia trachomatis linked to squamous cell cervical ca. Family
Practice News. 9.
Jones, R. B. (1999). Chlamydial infection. In P. J. Hitchcock, H. T. MacKay & J. N.
Wasserheit (Eds.), Sexually transmitted diseases and adverse outcomes of
pregnancy (pp. 195-208). Washington, DC: American Society for Microbiology.


172
the required sport physical. The same practice would enhance identification of
asymptomatic infections among incarcerated juveniles and young women, and adolescents
who seek routine immunizations Nurse practitioners, who work in family practice and
primary care settings, should incorporate chlamydia screening (and other STD screening)
along with improved sexual history elicitation into the preventive health and acute care
encounter with young women. This may require the revision of practice guidelines to
reflect the findings and content discussed in this study.
Establishment of multi-disciplinary collaborative case conferences, focused on
sexually transmitted infections during pregnancy, may assist county health departments
and their private community partners to better identify missed opportunities for
identification of early chlamydial infection and to provide timely treatment. Included in
these collaborations should be advanced practice nurses, certified nurse midwives,
physician assistants, infectious disease specialists, and disease investigators from both
private and public settings.
Other significant associations observed in this study between low birth weight, and
gonorrhea and syphilis, suggest numerous opportunities for nurse practitioners to
positively impact on clinical practice. For example, a urine pregnancy test should
appropriately be performed on all women with reactive syphilis serologies in the absence
of documented proof of sterilization or hormonal implants. The opportunity to identify an
early pregnancy in a woman with syphilis could both increase the likelihood for adequate,
and timely treatment, and also increase the outreach activities to identify all potential
partners and sources of re-infection during the pregnancy.


APPENDIX B
SYNTAX


214
Appendix A. Continued.
Original Variable
Name
New Variable
Name
Variable labels
DOTM
DOTM
year of last other terminations
DOT1
DOTY
year of last other terminations
PREFER
PREFER
number of total other terminations
LMPM
LMPM
Imp month
LMPD
LMPD
Imp day
LMPY
LMPY
Imp year
PREMO
PREMO
month prenatal care began
PREVIS
PREVIS
number of prenatal visits
BFD A
BFD
b or fd designation for birth record
BWG
BWG
birth weight group
LMPD AYS
LMPD AYS
calculated total Imp days
GWEEKS
GWEEKS
total gestation weeks
CDOBDAYS
CDOBDAYS
total gestational days for formula
GESTAGE
GESTAGE
gestational age
LBWGGEST
LBWGGEST
lbw by gestational age
AGEGROUP
AGEGROUP
moms age group
WTGAINGP
WTGAINGP
moms weight gain group
LBW AT B
LBW AT B
moms weight at her birth
WEIGHT B
WEIGHT B
moms weight before pregnancy
HEIGHT F
HEIGHT F
moms height feet
HEIGHT I
HEIGHT I
moms height inches
FIRST PR
l'Vregp
first pregnancy
YEAR LAS
YEAR LAS
year of last pregnancy
MONTH LA
MONTH LA
month of last pregnancy
HMO
HMO
pnc covered by hmo?
MEDICAID
MEDICAID
pnc covered by medicaid?
OTHER IN
OTHER IN
pnc covered by other health insurance?
NO COVER
NO COVER
no pnc coverage
APPOINTM
APPOINTM
mom has problems keeping appointments
MOVED
MOVED
mom moved more than 3 times in last 12 months
UNSAFE
UNSAFE
mom feels unsafe where she lives
HUNGRY
HUNGRY
anyone in household goes to bed hungry?
TOBACCO
TOBACCO
mom used tobacco in last 12 months?
DRUGALCO
DRUGALCO
mom used drug or alcohol in last 12 months?
HURTYOU
HURTYOU
has anyone hit mom or tried to hurt her?
STRESS
STRESS
how do you rate (mom) stress level?
PREFERPG
PREFERPG
if you could change the timing of tins pregnancy, would you want it
earlier, later, not at all, no change?
POOROUTC
POOROUTC
did last pregnancy result in poor birth outcome? (stillbirth,
miscarriage, <5.5 lbs, premature, baby stayed in hospital)
CHRONIC
CHRONIC
mom has chronic illness
CHD PROV
CHD PROV
chd provider
DOH CONT
DOH CONT
doh provider
PRIVATE
PRIVATE
private provider
TRIMESTE
TRIMESTE
trimester of pregnancy at first visit
OB HX FU
OB HX FU
number of full term pregnancies
OB HX PR
OB HX PR
number of pre-term pregnancies
OB HX AB
OB HX AB
number of abortions
OB HX LI
OB HX LI
number of live births
OB HX LB
OB HX LB
number of prior live lbw births
BFD B
BFD B
b or fd designation for healthy start screen
VI68
V168
certificate number healthy start
VI69
VI69
bfd number healthy start


222
VALUE LABELS ageindic
.000000000000000 age between 19 & 40'
1.00000000000000 "age <18 or >40".
To create a smoker indicator variable birth record.
compute smokindi=0.
if (TOBUSE =1) smokindi=l.
missing values smokindi (-1).
FORMATS smokindi (F8).
VARIABLE LABELS smokindi "smoker indicator".
VALUE LABELS smokindi
.000000000000000 non-smoker"
"smoker".
To create a smoker indicator variable for Healthy Start.
compute smokind2=0.
if (TOBACCO =1) smokind2=l.
missing