Status:
COMPLETED
Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy
Lead Sponsor:
Centers for Disease Control and Prevention
Conditions:
Vaginosis, Bacterial
Premature Birth
Eligibility:
FEMALE
16+ years
Phase:
PHASE2
Brief Summary
The goal of this study is to examine acceptability and efficacy of 2 kinds of BV treatment among women at low risk for preterm delivery. The objectives are: 1. To examine the side effects and patient...
Detailed Description
This is a randomized, placebo-controlled intervention trial. Women diagnosed as BV+ by Gram stain at 12-16 weeks gestation are randomly assigned to the following treatment groups: oral metronidazole (...
Eligibility Criteria
Inclusion
- Tested positive for bacerial vaginosis (Nugent score \>7)
- African American, Hispanic, Asian/Pacific Islander, Native American, and white women
Exclusion
- \>20 weeks gestaion
- history of preterm delivery
- had a multiple gestation pregnancy
- had major medical complications (e.g., chronic hypertension or pre-existing diabetes)
- antibiotic use within 7 days of screening visit for enrollment in the study,
- allergy to metronidazole
- history of alcohol dependency in past year women under age 16
Key Trial Info
Start Date :
October 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00153517
Start Date
October 1 1999
End Date
September 1 2004
Last Update
May 29 2024
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98185