CompletedPhase 2

Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy

United States126 participantsStarted 1999-10

Plain-language 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 acceptability of oral versus intravaginal metronidazole. 2. To compare the efficacy of oral and intravaginal metronidazole for the treatment of BV 3. To study the efficacy of oral and intravaginal metronidazole for the prevention of hospital admission during the 3rd trimester, chorioamnionitis, preterm delivery, and maternal infectious morbidity.

Who can participate

Age range16 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Tested positive for bacerial vaginosis (Nugent score \>7) * African American, Hispanic, Asian/Pacific Islander, Native American, and white women Exclusion Criteria: * \>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

What they're measuring

Microbiological, Clinical, and Therapeutic Cure Rates at Follow-Up among Women Treated with Oral vs. Intravaginal Metronidazole

Timeframe: 4 weeks after treatment

Trial details

NCT IDNCT00153517

SponsorCenters for Disease Control and Prevention

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2004-09

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