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Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity

NCT03954990 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-12-12

No results posted yet for this study

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

Conditions

  • Bacterial Vaginoses

Interventions

DRUG

Metronidazole Oral

4 tablets (2 g of metronidazole)

DRUG

Placebo Oral Tablet

4 tablets

Sponsors & Collaborators

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Sangeeta Jain, MD · University of Texas medical branch, Galveston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-11
Primary Completion
2022-09-26
Completion
2022-09-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03954990 on ClinicalTrials.gov