Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity

Phase 1TerminatedNCT03954990

The University of Texas Medical Branch, Galveston75 enrolled

Overview

Bacterial vaginosis (BV) is the most common cause of vaginal discharge among repro-ductive aged women. It is been linked to adverse maternal and neonatal outcomes. Our objective is to evaluate if the use of a single dose of metronidazole in women with BV at time of delivery reduces infectious morbidities

The investigators are proposing a double-blinded, placebo controlled, randomized trial of 525 pregnant women undergoing induction or admitted in early labor and who are diagnosed with bacterial vaginosis. On admission to labor and delivery, patient will be counseled about the study. Patients who agree to be enrolled, will sign informed consent. Following enrollment patients will be screened for Bacterial vaginosis by doing a speculum exam and testing for Amsel's criteria. BV +ve patients will be randomized to receive either metronidazole 2 grams PO once or identically appearing placebo. The PI, study coordinator, or a collaborator will be responsible for the informed consent. This will be a double-blinded randomized clinical trial. Neither the patient nor provider will be aware of treatment assignment. As with any other in-stance in which antibiotics are administered, there is a chance of an allergic or other adverse reaction. The patient will receive standard inpatient monitoring during the labor course and in the postpartum period, and so any immediate adverse reaction would be promptly detected. Patient will be assessed intrapartum for development of chorioamninoitis. Postpartum patient will be assessed for infective complications up to 4 weeks. Neonates will be assessed for morbidities by chart review for 90 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Bacterial Vaginoses

Interventions

Metronidazole OralDRUG

4 tablets (2 g of metronidazole)

Placebo Oral TabletDRUG

4 tablets

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women ≤50 years at the time of admission with the ability to give informed con-sent. * Admission for induction of labor or early spontaneous labor with cervix ≤3 cm. * Diagnosed with bacterial vaginosis at time of admission or in the week prior to admission if not treated * Gestational age ≥ 34 weeks Exclusion Criteria: * Spontaneous rupture of membranes * Plan for elective cesarean delivery * Allergy or contraindications to metronidazole * Receipt of metronidazole or clindamycin in the admission for delivery for other in-dications. * Hemodialysis * Severe liver dysfunction * Diagnosis of chorioamnionitis at the time of admission

Locations (1)

University of Texas Medical Branch

Galveston, Texas, United States

Outcomes

Primary Outcomes

Rate of Composite outcome of maternal infections

Including Chorioamnionitis, postpartum endometritis, wound infection, pelvic septic thrombosis, pelvic or abdominal abscess

Time frame: Labor to 4 weeks postpartum

Secondary Outcomes

Rate of Chorioamnionitis

Presumptive or confirmed diagnosis

Time frame: From beginning of labor process until time of delivery

Rate of Postpartum Endometritis

Postpartum intrauterine infection

Time frame: From time of delivery to 4 weeks postpartum

Rate of Surgical Site Infection

Including superficial or deep incisional surgical site infection

Time frame: 4 weeks postpartum

Rate of Pelvic Septic Thrombosis

Infection and thrombosis of pelvic vessels

Time frame: 4 weeks postpartum

Rate of Pelvic abscess

Detection of pelvic abscess on imaging

Time frame: 4 weeks postpartum

Rate of Puerperal fever

Temperature of ≥ 100.4 F at least twice 30 minutes apart or once ≥ 101F

Time frame: From beginning of labor process until time of delivery

Rate of Maternal Death

Death of mother while pregnant or within 28 days of pregnancy termination from any cause related to pregnancy or its management.

Data from ClinicalTrials.gov

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