Clinical trial NCT04578015: A Randomized Controlled Trial of Treatment of Bacterial Vaginosis
Official title: A Randomized Controlled Trial of Treatment of Bacterial Vaginosis in Late Third Trimester to Prevent Maternal Peripartum Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Bacterial Vaginoses
Keywords: Bacterial Vaginoses
Cesarean delivery
Surgical site infection
Endometritis
Infection
Vaginitis
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluating Composite of Chorioamnionitis, Postpartum Endometritis, SSI, Wound Infection, or Other Post-cesarean Infections (Occurring Within 6 Weeks After Delivery)
timeFrame: Through study completion, approximately 9.5 months
Secondary outcomes:
measure: Evaluating Incidence of Individual Infections.
timeFrame: At the time of admission for labor trough study completion, approximately 9.5 months
measure: Evaluating Incidence of Maternal Death
timeFrame: After delivery through study completion, approximately 9.5 months
measure: Evaluating Incidence of Puerperal Fever.
timeFrame: Through study completion, approximately 9.5 months
measure: Evaluating Incidence of Use of Resources.
timeFrame: Through study completion, approximately 9.5 months
measure: Evaluating Incidence of Adverse Events
timeFrame: Through study completion, approximately 9.5 months
measure: Evaluating Incidence of Suspected Sepsis for Newborns
timeFrame: Within 7 days of delivery
measure: Evaluating Incidence of Confirmed Sepsis for Newborns
timeFrame: Within 7 days of delivery
measure: Evaluating Incidence of Newborn Intensive Care Unit (NICU) Admission and Duration
timeFrame: After delivery through study completion, approximately 9.5 months
measure: Evaluating Incidence of Neonatal Morbidities
timeFrame: After delivery through study completion, approximately 9.5 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
state: Ohio
Study officials:
References: