A Randomized Controlled Trial of Treatment of Bacterial Vaginosis

Phase 4TerminatedNCT04578015

Ohio State University16 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Bacterial Vaginoses

Interventions

MetronidazoleDRUG

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

PlaceboDRUG

Participants in this arm will receive placebo

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Columbus, Ohio, United States

Outcomes

Primary Outcomes

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

Time frame: Through study completion, approximately 9.5 months

Secondary Outcomes

Evaluating Incidence of Individual Infections.

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

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

Evaluating Incidence of Maternal Death

Time frame: 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.

Time frame: 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.

Time frame: 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)

Time frame: Through study completion, approximately 9.5 months

Evaluating Incidence of Suspected Sepsis for Newborns

Data from ClinicalTrials.gov

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