Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy

Centers for Disease Control and Prevention (CDC)

Status and phase: Completed; Phase 2

Conditions: Chorioamnionitis; Birth Weight; Vaginosis, Bacterial; Premature Birth

Treatments: Drug: oral versus vaginal metronidazole

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00153517

CDC-NCCDPHP-2752

U36CCU300430-1179

U36CCU300430-2239

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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126 participants in 2 patient groups

Oral Treatment

Active Comparator group

Description:

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

Treatment:

Drug: oral versus vaginal metronidazole

Vaginal Treatment

Active Comparator group

Description:

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

Treatment:

Drug: oral versus vaginal metronidazole