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NCT00153517 Clinical Trial

Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy

Premature Birth Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00153517
Other study ID # CDC-NCCDPHP-2752
Secondary ID U36CCU300430-223
Status Completed
Phase Phase 2
First received
Last updated
Start date October 1999
Est. completion date March 2005

Study information
Verified date September 2005
Source Centers for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 126
Est. completion date March 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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. -

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• oral versus vaginal metronidazole

Locations
Country Name City State
United States University of Washington Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary changes in vaginal flora
Secondary preterm delivery
Secondary low birth weight
Secondary chorioamnionitis
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