Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-10-31

Study Completion Date

2004-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vaginosis, Bacterial Premature Birth Birth Weight Chorioamnionitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

study participants were randomized to treatment with oral metronidazole (Centers for Disease Control and Prevention \[CDC\] recommended regimen: 250mg three times daily for 7 days) plus intravaginal placebo or intravaginal metronidazole (5 g of 0.75% gel twice daily for 5 days) plus oral placebo. The oral and vaginal placebos were indistinguishable from active therapy. Randomization to study group used random number tables, with a 1:1 ratio between study groups.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The Investigational Drug Service at the University of Washington performed the randomization and provided the treatment assignments in opaque, sealed envelopes. Neither the subjects nor the study personnel assessing treatment effect were aware of which active agent had been assigned.

Study Groups

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Oral Treatment

oral (250mg three times daily for 7 days) metronidazole

Group Type ACTIVE_COMPARATOR

oral versus vaginal metronidazole

Intervention Type DRUG

Vaginal Treatment

intravaginal (5 g of 0.75% gel twice daily for 5 days) metronidazole

Group Type ACTIVE_COMPARATOR

oral versus vaginal metronidazole

Intervention Type DRUG

Interventions

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oral versus vaginal metronidazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Tested positive for bacerial vaginosis (Nugent score \>7)
* African American, Hispanic, Asian/Pacific Islander, Native American, and white women

Exclusion Criteria

* \>20 weeks gestaion
* history of preterm delivery
* had a multiple gestation pregnancy
* had major medical complications (e.g., chronic hypertension or pre-existing diabetes)
* antibiotic use within 7 days of screening visit for enrollment in the study,
* allergy to metronidazole
* history of alcohol dependency in past year women under age 16

Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No