Trial Outcomes & Findings for A Randomized Controlled Trial of Treatment of Bacterial Vaginosis (NCT NCT04578015)

NCT ID: NCT04578015

Last Updated: 2023-06-15

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 16 participants
• Primary outcome timeframe: Through study completion, approximately 9.5 months
• Results posted on: 2023-06-15

Participant Flow

Participant milestones

Measure	Metronidazole 500 mg Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days Metronidazole: Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days	Placebo Participants in this arm will receive placebo Placebo: Participants in this arm will receive placebo
Overall Study STARTED	8	8
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	8	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Randomized Controlled Trial of Treatment of Bacterial Vaginosis

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: Through study completion, approximately 9.5 months

Population: Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At the time of admission for labor trough study completion, approximately 9.5 months

Population: Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study.

Chorioamnionitis, endometritis, wound infection (including necrotizing fascitis), other infections including abscess, septic thrombosis, pneumonia, pyelonephritis and breast infection.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After delivery through study completion, approximately 9.5 months

Population: Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through study completion, approximately 9.5 months

Population: Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study.

Temperature > 100.4 F at least twice 30 minutes apart, or once with the use of antipyretic, or ≥101 F once.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through study completion, approximately 9.5 months

Population: Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study.

Hospital stay, postpartum clinic or emergency room visit within 4 weeks of delivery, need for imaging or other invasive procedures, postpartum antibiotic use.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through study completion, approximately 9.5 months

Population: Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study.

Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis), GI symptoms (nausea, vomiting, diarrhea, constipation, ileus, etc)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 7 days of delivery

Population: Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 7 days of delivery

Population: Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After delivery through study completion, approximately 9.5 months

Population: Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After delivery through study completion, approximately 9.5 months

Population: Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study.

Outcome measures

Outcome data not reported

Adverse Events

Metronidazole 500 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kartik Venkatesh, MD, PhD

The Ohio State University

Phone: 614-293-2222

Email: kartik.venkatesh@osumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place