A Randomized Controlled Trial of Treatment of Bacterial Vaginosis in Late Third Trimester to Prevent Maternal Peripartum Infection

2020H0476

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.

2021-04-26

2022-02-09

2022-02-09

Terminated

Early phase I

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 16, 'type': 'ACTUAL'}}

2023-06-15