Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy
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.
Drug: oral versus vaginal metronidazole
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy (Randomized Trial of BV Treatment in Pregnancy)|
- changes in vaginal flora
- preterm delivery
- low birth weight
|Study Start Date:||October 1999|
|Estimated Study Completion Date:||March 2005|
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.
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98185|
|Principal Investigator:||Jane E Hitti, MD, MPH||University of Washington|