Bacterial vaginosis (BV) is extremely prevalent among low-income, urban pregnant women. The current standard of medical care does not involve screening pregnant women for BV unless clinical symptoms are reported; however, the majority of pregnant women with BV are asymptomatic. A number of studies have found associations between BV and late pregnancy outcomes; such as, preterm labor, premature rupture of membrane, chorioamnionitis, and low birth weight. The impact of BV on the risk for spontaneous abortion (SAB) is unclear. In the proposed prospective cohort study, all women will be screened for BV early in pregnancy regardless of symptoms.
The specific aims of this study are to: 1) characterize the prevalence and predictors of BV in women early in pregnancy and 2) evaluate whether BV during pregnancy is an important, independent predictor of SAB. Women attending their first clinical prenatal care visit at the Hospital of the University of Pennsylvania Obstetric Clinic with a pregnancy of 12 weeks gestation or less as determined by last menstrual period will be recruited. We will screen all women for bacterial vaginosis and follow-up through 22 weeks gestation to identify women experiencing a spontaneous abortion. We will enroll 2200 women over a three year period arid compare SAB rates for the estimated 400 women found to test positive for BY (20 percent of patients) and the 1600 women found to test negative for By. Baseline data collection will be standardized and include a structured in-person interview, a vaginal smear used to detect By, and urine analysis to determine alcohol, cocaine and cotinine. Follow-up telephone interviews will be conducted at 22 weeks gestation to determine the status of pregnancy (SAB vs. non-SAB) and BV diagnosis and treatment. Pregnancy outcome status will also be ascertained through ongoing review of medical records, pathology logs and birth certificates. Initial analyses will be exploratory and descriptive, characterizing the prevalence and predictors of BV and the risk factors for SAB. The primary analysis will be logistic regression, with relative risks and 95 percent confidence intervals, to explore whether BV is an independent predictor of SAB. This study will provide a unique opportunity to evaluate the prevalence of BV among pregnant women and to determine the relationship between BV and incident SAB.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
1R01HD038856-01A1
Application #
6331914
Study Section
Epidemiology and Disease Control Subcommittee 2 (EDC)
Program Officer
Willinger, Marian
Project Start
2001-06-01
Project End
2005-03-31
Budget Start
2001-06-01
Budget End
2002-03-31
Support Year
1
Fiscal Year
2001
Total Cost
$469,177
Indirect Cost
Name
University of Pennsylvania
Department
Biostatistics & Other Math Sci
Type
Schools of Medicine
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
Nelson, Deborah B; Shin, Hakdong; Wu, Jingwei et al. (2016) The Gestational Vaginal Microbiome and Spontaneous Preterm Birth among Nulliparous African American Women. Am J Perinatol 33:887-93
Nelson, Deborah B; Hanlon, Alexandra L; Wu, Guojiao et al. (2015) First Trimester Levels of BV-Associated Bacteria and Risk of Miscarriage Among Women Early in Pregnancy. Matern Child Health J 19:2682-7
Seravalli, Laura; Patterson, Freda; Nelson, Deborah B (2014) Role of perceived stress in the occurrence of preterm labor and preterm birth among urban women. J Midwifery Womens Health 59:374-9
Nelson, Deborah B; Hanlon, Alexandra; Nachamkin, Irving et al. (2014) Early pregnancy changes in bacterial vaginosis-associated bacteria and preterm delivery. Paediatr Perinat Epidemiol 28:88-96
Herring, Sharon J; Nelson, Deborah B; Pien, Grace W et al. (2014) Objectively measured sleep duration and hyperglycemia in pregnancy. Sleep Med 15:51-5
Herring, Sharon J; Foster, Gary D; Pien, Grace W et al. (2013) Do pregnant women accurately report sleep time? A comparison between self-reported and objective measures of sleep duration in pregnancy among a sample of urban mothers. Sleep Breath 17:1323-7
Mitchell, Caroline; Gottsch, Michelle L; Liu, Congzhou et al. (2013) Associations between vaginal bacteria and levels of vaginal defensins in pregnant women. Am J Obstet Gynecol 208:132.e1-7
Nelson, Deborah B; Komaroff, Eugene; Nachamkin, Irving et al. (2013) Relationship of selected bacterial vaginosis-associated bacteria to Nugent score bacterial vaginosis among urban women early in pregnancy. Sex Transm Dis 40:721-3
Herring, Sharon J; Nelson, Deborah B; Davey, Adam et al. (2012) Determinants of excessive gestational weight gain in urban, low-income women. Womens Health Issues 22:e439-46
Uscher-Pines, Lori; Hanlon, Alexandra L; Nelson, Deborah B (2009) Racial differences in bacterial vaginosis among pregnant women: the relationship between demographic and behavioral predictors and individual BV-related microorganism levels. Matern Child Health J 13:512-9

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