A Randomized Controlled Trial of Treatment of Bacterial Vaginosis

Phase 4

Terminated

Conditions: Bacterial Vaginoses

Interventions: Drug: Metronidazole
Drug: Placebo

Registration Number: NCT04578015

Lead Sponsor: Ohio State University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 16

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

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