DESCRIPTION: 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.
Eunice Kennedy Shriver National Institute of Child Health and Human Development
CFDA Code
865
DUNS Number
042250712
UEI
GM1XX56LEP58
Project Start Date
01-June-2001
Project End Date
31-March-2005
Budget Start Date
01-April-2003
Budget End Date
31-March-2004
Project Funding Information for 2003
Total Funding
$611,480
Direct Costs
$385,792
Indirect Costs
$225,688
Year
Funding IC
FY Total Cost by IC
2003
Eunice Kennedy Shriver National Institute of Child Health and Human Development
$611,480
Year
Funding IC
FY Total Cost by IC
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