Clinical Trial: Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy (Randomized Trial of BV Treatment in Pregnancy)
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:
- To examine the side effects and patient acceptability of oral versus intravaginal metronidazole.
- To compare the efficacy of oral and intravaginal metronidazole for the treatment of BV
- 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.
Detailed Summary: 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 (250 mg TID x 7 days) with intravaginal placebo; intravaginal metronidazole (5g 0.75% gel BID x 5 days) with oral placebo. African American, Hispanic, Asian/Pacific Islander, Native American, and white women are eligible. Women with a prior preterm delivery, multiple gestation, chronic hypertension or pre-existing diabetes, antibiotic use before enrollment in the study, allergy to metronidazole, history of alcohol abuse in past year, and women under age 18 are excluded.
Sponsor: Centers for Disease Control and Prevention
Current Primary Outcome: changes in vaginal flora
Original Primary Outcome: Same as current
Current Secondary Outcome:
- preterm delivery
- low birth weight
- chorioamnionitis
Original Secondary Outcome: Same as current
Information By: Centers for Disease Control and Prevention
Dates:
Date Received: September 8, 2005
Date Started: October 1999
Date Completion: March 2005
Last Updated: September 8, 2005
Last Verified: September 2005
