Suspended

A Randomized Controlled Trial of Treatment of Bacterial Vaginosis in Late Third Trimester to Prevent Maternal Peripartum Infection

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What is being tested

Metronidazole

+ Placebo

Drug
Who is being recruted

Urogenital Diseases+17

+ Genital Diseases

+ Adnexal Diseases

From 18 to 50 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: April 2021
See protocol details

Summary

Principal SponsorOhio State University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 26, 2021

Actual date on which the first participant was enrolled.

This is a double-blinded, placebo controlled, multi-center randomized trial of 482 pregnant women who are diagnosed with Bacterial Vaginosis (BV) in the late 3rd trimester (>34 weeks). During routine clinic visit after 34 weeks, prospective patients will be counseled about the study. Patients who agree to be enrolled, will sign informed consent. Following enrollment, patients will be screened for BV. Those patients who are BV positive by clinical diagnosis, will be randomized to receive either metronidazole 500 mg BID orally for 7 days or identically appearing placebo.

Official TitleA Randomized Controlled Trial of Treatment of Bacterial Vaginosis in Late Third Trimester to Prevent Maternal Peripartum Infection
NCT04578015
Principal SponsorOhio State University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

16 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesPelvic Inflammatory DiseaseBacterial Infections and MycosesBacterial InfectionsEndometritisFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleInfectionsPathologic ProcessesPostoperative ComplicationsSurgical Wound InfectionPathological Conditions, Signs and SymptomsUterine DiseasesVaginal DiseasesVaginitisWound InfectionVaginosis, BacterialFemale Urogenital Diseases

Criteria

4 inclusion criteria required to participate
Pregnant women 18 to ≤50 years with the ability to give informed consent.
Patients expected to have a vaginal delivery with no obstetric contraindication for vaginal delivery at time of screening.
Diagnosed with bacterial BV per Amsel criteria at time of screening in clinic.
Gestational age ≥ 35 weeks
6 exclusion criteria prevent from participating
Plan for elective cesarean delivery
Allergy or contraindications to metronidazole
Receipt of metronidazole or clindamycin on admission for delivery for other indications.
Hemodialysis
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days

Group II

Placebo
Participants in this arm will receive placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Columbus, United StatesOpen The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine in Google Maps
SuspendedOne Study Center