A Randomized Controlled Trial of Treatment of Bacterial Vaginosis

NCT04578015 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2020H0476
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Bacterial Vaginoses; Cesarean delivery; Surgical site infection; Endometritis; Infection; Vaginitis

Outcome Measures

Primary Outcomes (1)

• Evaluating Composite of Chorioamnionitis, Postpartum Endometritis, SSI, Wound Infection, or Other Post-cesarean Infections (Occurring Within 6 Weeks After Delivery)

  Through study completion, approximately 9.5 months

Secondary Outcomes (9)

• Evaluating Incidence of Individual Infections.

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

• Evaluating Incidence of Maternal Death

  After delivery through study completion, approximately 9.5 months

• Evaluating Incidence of Puerperal Fever.

  Through study completion, approximately 9.5 months

• Evaluating Incidence of Use of Resources.

  Through study completion, approximately 9.5 months

• Evaluating Incidence of Adverse Events

  Through study completion, approximately 9.5 months

Study Arms (2)

Metronidazole 500 mg

ACTIVE COMPARATOR

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

Drug: Metronidazole

Placebo

PLACEBO COMPARATOR

Participants in this arm will receive placebo

Drug: Placebo

Interventions

Metronidazole DRUG

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

Metronidazole 500 mg

Placebo DRUG

Participants in this arm will receive placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Plan for elective cesarean delivery
• Allergy or contraindications to metronidazole
• Receipt of metronidazole or clindamycin on admission for delivery for other indications.
• Hemodialysis
• Severe liver dysfunction
• Patient reports BV to nurse or clinician provider at current clinic visit or has been treated for BV within the past 3 months.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

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

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Vaginosis, Bacterial; Surgical Wound Infection; Endometritis; Infections; Vaginitis

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Inflammatory Disease; Adnexal Diseases; Uterine Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Kartik Venkatesh, MD, PhD
• Organization: The Ohio State University

kartik.venkatesh@osumc.edu

614-293-2222

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD Assistant Professor

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 8, 2020
• Study Start: April 26, 2021
• Primary Completion: February 9, 2022
• Study Completion: February 9, 2022
• Last Updated: June 15, 2023
• Results First Posted: June 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)