Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy

Sponsor

Centers for Disease Control and Prevention (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00153517

Collaborator

(none)

126

Enrollment

Location

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vaginosis, Bacterial Premature Birth Birth Weight Chorioamnionitis	Drug: oral versus vaginal metronidazole	Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 1999

Study Completion Date :

Mar 1, 2005

Outcome Measures

Primary Outcome Measures

changes in vaginal flora []

Secondary Outcome Measures

preterm delivery []
low birth weight []
chorioamnionitis []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.