A Randomized Controlled Trial of Treatment of Bacterial Vaginosis

Bacterial Vaginoses Clinical Trial

Official title:

A Randomized Controlled Trial of Treatment of Bacterial Vaginosis in Late Third Trimester to Prevent Maternal Peripartum Infection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04578015
• Other study ID #: 2020H0476
• Status: Terminated
• Phase: Phase 4
• Start date: April 26, 2021
• Est. completion date: February 9, 2022

Study information

• Verified date: May 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: February 9, 2022
• Est. primary completion date: February 9, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Vaginoses
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• Metronidazole
Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days
• Placebo
Participants in this arm will receive placebo

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating Composite of Chorioamnionitis, Postpartum Endometritis, SSI, Wound Infection, or Other Post-cesarean Infections (Occurring Within 6 Weeks After Delivery)		Through study completion, approximately 9.5 months
Secondary	Evaluating Incidence of Individual Infections.	Chorioamnionitis, endometritis, wound infection (including necrotizing fascitis), other infections including abscess, septic thrombosis, pneumonia, pyelonephritis and breast infection.	At the time of admission for labor trough study completion, approximately 9.5 months
Secondary	Evaluating Incidence of Maternal Death		After delivery through study completion, approximately 9.5 months
Secondary	Evaluating Incidence of Puerperal Fever.	Temperature > 100.4 F at least twice 30 minutes apart, or once with the use of antipyretic, or =101 F once.	Through study completion, approximately 9.5 months
Secondary	Evaluating Incidence of Use of Resources.	Hospital stay, postpartum clinic or emergency room visit within 4 weeks of delivery, need for imaging or other invasive procedures, postpartum antibiotic use.	Through study completion, approximately 9.5 months
Secondary	Evaluating Incidence of Adverse Events	Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis), GI symptoms (nausea, vomiting, diarrhea, constipation, ileus, etc)	Through study completion, approximately 9.5 months
Secondary	Evaluating Incidence of Suspected Sepsis for Newborns		Within 7 days of delivery
Secondary	Evaluating Incidence of Confirmed Sepsis for Newborns		Within 7 days of delivery
Secondary	Evaluating Incidence of Newborn Intensive Care Unit (NICU) Admission and Duration		After delivery through study completion, approximately 9.5 months
Secondary	Evaluating Incidence of Neonatal Morbidities		After delivery through study completion, approximately 9.5 months