Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy

Phase 2

Completed

• Conditions: Birth Weight; Chorioamnionitis; Vaginosis, Bacterial; Premature Birth
• Interventions: Drug: oral versus vaginal metronidazole

• Registration Number: NCT00153517
• Lead Sponsor: Centers for Disease Control and Prevention

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:

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.

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 Timeline

• Study Start: 1999-10
• Primary Completion: 2004-09
• Study Completion: 2004-09
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal Treatment	oral versus vaginal metronidazole	intravaginal (5 g of 0.75% gel twice daily for 5 days) metronidazole
Oral Treatment	oral versus vaginal metronidazole	oral (250mg three times daily for 7 days) metronidazole

Primary Outcome Measures

Name	Time	Method
Microbiological, Clinical, and Therapeutic Cure Rates at Follow-Up among Women Treated with Oral vs. Intravaginal Metronidazole	4 weeks after treatment	Cure rates were assessed by Gram Stain Score (0-3, 4-6, 7-10); Abnormal clincial signs (0, 1-2, 3-4); Therapeutic cure (Gram Stain 0-3 and no symptoms) treatment

Secondary Outcome Measures

Name	Time	Method
low birth weight	at delivery	birth weight less than 2500 grams
preterm delivery	at delivery	rate of delivery before 37 completed weeks gestation in intervention groups

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States