Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy
Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy (Randomized Trial of BV Treatment in Pregnancy)
Sponsor: Centers for Disease Control and Prevention
A PHASE2 clinical study on Birth Weight and Chorioamnionitis, this trial is completed. The trial is conducted by Centers for Disease Control and Prevention and has accumulated 7 data snapshots since 1999. Infectious disease trials contribute critical data for public health response and treatment development.
Study Description(click to expand)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.
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.
Status Flow
Change History
7 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE2
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Sep 2024 — Present [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Jun 2024 — Jul 2024 [monthly]
Completed PHASE2
-
May 2024 — Jun 2024 [monthly]
Completed PHASE2
▶ Show 2 earlier versions
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Jan 2021 — May 2024 [monthly]
Completed PHASE2
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Jan 2017 — Jan 2021 [monthly]
Completed PHASE2
First recorded
Oct 1999
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Centers for Disease Control and Prevention
For direct contact, visit the study record on ClinicalTrials.gov .