Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy

Condition(s) targeted: Vaginosis, Bacterial; Premature Birth; Birth Weight; Chorioamnionitis

Intervention: oral versus vaginal metronidazole (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Centers for Disease Control and Prevention

Official(s) and/or principal investigator(s):
Jane E Hitti, MD, MPH, Principal Investigator, Affiliation: University of Washington

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.

Official title: Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy (Randomized Trial of BV Treatment in Pregnancy)

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: changes in vaginal flora

Secondary outcome:

preterm delivery

low birth weight

chorioamnionitis

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 (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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria: African American, Hispanic, Asian/Pacific Islander, Native American, and white women.

-

Exclusion Criteria: 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.

-

University of Washington, Seattle, Washington 98185, United States

Starting date: October 1999
Ending date: March 2005
Last updated: September 8, 2005