deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT00153517

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

Updated 7 times since 2017 Last updated: May 28, 2024 Started: Oct 31, 1999 Primary completion: Sep 30, 2004 Completion: Sep 30, 2004
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~Jan 2021 · 48 months · monthly snapshotCompleted~Jan 2021 – ~May 2024 · 40 months · monthly snapshotCompleted~May 2024 – ~Jun 2024 · 31 days · monthly snapshotCompleted~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Present [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jun 2024 — Jul 2024 [monthly]

    Completed PHASE2

  5. May 2024 — Jun 2024 [monthly]

    Completed PHASE2

Show 2 earlier versions
  1. Jan 2021 — May 2024 [monthly]

    Completed PHASE2

  2. 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

Sponsor contact:
  • Centers for Disease Control and Prevention
Data source: Centers for Disease Control and Prevention

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations