Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity

NCT ID: NCT03954990

Last Updated: 2023-12-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-11
• Study Completion Date: 2022-09-26

Brief Summary

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

Detailed Description

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.

Conditions

Bacterial Vaginoses

Keywords

Bacterial Vaginoses in pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Control Arm

Placebo tablets oral, 4 tablets once.

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

4 tablets

Treatment Arm

Will receive 4 tablets (2g) of metronidazole oral once.

Group Type: ACTIVE_COMPARATOR

Metronidazole Oral

Intervention Type: DRUG

4 tablets (2 g of metronidazole)

Interventions

Metronidazole Oral

4 tablets (2 g of metronidazole)

Intervention Type: DRUG

Placebo Oral Tablet

4 tablets

Intervention Type: DRUG

Other Intervention Names

Flagyl

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sangeeta Jain, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas medical branch, Galveston

Locations

University of Texas Medical Branch

Galveston, Texas, United States

Countries

United States

Other Identifiers

18-0103

Identifier Type: -

Identifier Source: org_study_id