Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity

  • STATUS
    Recruiting
  • End date
    Aug 31, 2022
  • participants needed
    525
  • sponsor
    The University of Texas Medical Branch, Galveston
Updated on 8 August 2021
metronidazole
oral metronidazole
vaginal discharge
repro
bacterial vaginosis

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

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.

Details
Condition Bacterial Vaginosis, Bacterial Infection, Bacterial Infections, Vaginitis
Treatment Placebo Oral Tablet, Metronidazole Oral
Clinical Study IdentifierNCT03954990
SponsorThe University of Texas Medical Branch, Galveston
Last Modified on8 August 2021

Eligibility

Yes No Not Sure

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
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