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

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.

Study Overview

• Status: Terminated
• Conditions: Bacterial Vaginoses
• Intervention / Treatment: Drug: Metronidazole; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Metronidazole 500 mg; Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days	Drug: Metronidazole; Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days
Placebo Comparator: Placebo; Participants in this arm will receive placebo	Drug: Placebo; Participants in this arm will receive placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluating Incidence of Individual Infections.	Chorioamnionitis, endometritis, wound infection (including necrotizing fascitis), other infections including abscess, septic thrombosis, pneumonia, pyelonephritis and breast infection.	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.	Temperature > 100.4 F at least twice 30 minutes apart, or once with the use of antipyretic, or ≥101 F once.	Through study completion, approximately 9.5 months
Evaluating Incidence of Use of Resources.	Hospital stay, postpartum clinic or emergency room visit within 4 weeks of delivery, need for imaging or other invasive procedures, postpartum antibiotic use.	Through study completion, approximately 9.5 months
Evaluating Incidence of Adverse Events	Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis), GI symptoms (nausea, vomiting, diarrhea, constipation, ileus, etc)	Through study completion, approximately 9.5 months
Evaluating Incidence of Suspected Sepsis for Newborns		Within 7 days of delivery
Evaluating Incidence of Confirmed Sepsis for Newborns		Within 7 days of delivery
Evaluating Incidence of Newborn Intensive Care Unit (NICU) Admission and Duration		After delivery through study completion, approximately 9.5 months
Evaluating Incidence of Neonatal Morbidities		After delivery through study completion, approximately 9.5 months

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2021
• Primary Completion (Actual): February 9, 2022
• Study Completion (Actual): February 9, 2022

Study Registration Dates

• First Submitted: October 1, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: May 21, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Infection; Vaginitis; Cesarean delivery; Surgical site infection; Endometritis; Bacterial Vaginoses
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vaginal Diseases; Vaginosis, Bacterial; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: 2020H0476

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No