NCT04578015

A Randomized Controlled Trial of Treatment of Bacterial Vaginosis

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Bacterial Vaginoses

Interventions

Type	Name	Description
DRUG	Metronidazole	Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days
DRUG	Placebo	Participants in this arm will receive placebo

Timeline

• Start date: 2021-04-26
• Primary completion: 2022-02-09
• Completion: 2022-02-09
• First posted: 2020-10-08
• Last updated: 2023-06-15
• Results posted: 2023-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study