A Randomized Controlled Trial of Treatment of Bacterial Vaginosis

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-26

Study Completion Date

2022-02-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Bacterial Vaginoses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Metronidazole 500 mg

Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days

Group Type ACTIVE_COMPARATOR

Metronidazole

Intervention Type DRUG

Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days

Placebo

Participants in this arm will receive placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants in this arm will receive placebo

Interventions

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Metronidazole

Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days

Intervention Type DRUG

Placebo

Participants in this arm will receive placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No