A Randomized Controlled Trial of Treatment of Bacterial Vaginosis

Study Overview
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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.

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

Conditions
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Bacterial Vaginoses

Intervention / Treatment
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* Drug: Metronidazole
* Drug: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metronidazole 500 mg<br>Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days | Drug: Metronidazole<br>* Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days<br>|
| Placebo Comparator: Placebo<br>Participants in this arm will receive placebo | Drug: Placebo<br>* Participants in this arm will receive placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Evaluating Incidence of Maternal Death |  | After delivery through study completion, approximately 9.5 months | 
| 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 | 
| 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 | 
| 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 | 
| Evaluating Incidence of Suspected Sepsis for Newborns |  | Within 7 days of delivery | 
| Evaluating Incidence of Confirmed Sepsis for Newborns |  | Within 7 days of delivery | 
| Evaluating Incidence of Newborn Intensive Care Unit (NICU) Admission and Duration |  | After delivery through study completion, approximately 9.5 months | 
| Evaluating Incidence of Neonatal Morbidities |  | After delivery through study completion, approximately 9.5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bacterial Vaginoses, Cesarean delivery, Surgical site infection, Endometritis, Infection, Vaginitis