Back to resultsA Randomized Controlled Trial of Treatment of Bacterial Vaginosis
Primary Purpose
Bacterial Vaginoses
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Metronidazole
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Vaginoses focused on measuring Bacterial Vaginoses, Cesarean delivery, Surgical site infection, Endometritis, Infection, Vaginitis
Eligibility Criteria
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.
Sites / Locations
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Metronidazole 500 mg
Placebo
Arm Description
Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days
Participants in this arm will receive placebo
Outcomes
Primary Outcome Measures
Evaluating Composite of Chorioamnionitis, Postpartum Endometritis, SSI, Wound Infection, or Other Post-cesarean Infections (Occurring Within 6 Weeks After Delivery)
Secondary Outcome Measures
Evaluating Incidence of Individual Infections.
Chorioamnionitis, endometritis, wound infection (including necrotizing fascitis), other infections including abscess, septic thrombosis, pneumonia, pyelonephritis and breast infection.
Evaluating Incidence of Maternal Death
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.
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.
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)
Evaluating Incidence of Suspected Sepsis for Newborns
Evaluating Incidence of Confirmed Sepsis for Newborns
Evaluating Incidence of Newborn Intensive Care Unit (NICU) Admission and Duration
Evaluating Incidence of Neonatal Morbidities
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04578015
Brief Title
A Randomized Controlled Trial of Treatment of Bacterial Vaginosis
Official Title
A Randomized Controlled Trial of Treatment of Bacterial Vaginosis in Late Third Trimester to Prevent Maternal Peripartum Infection
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
After screening many patients for BV, it was determined that the rate of BV is less in our population that the 30% rate mentioned in the literature. It was determined that completing the study will not be feasible due to cost and time constraints.
Study Start Date
April 26, 2021 (Actual)
Primary Completion Date
February 9, 2022 (Actual)
Study Completion Date
February 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginoses
Keywords
Bacterial Vaginoses, Cesarean delivery, Surgical site infection, Endometritis, Infection, Vaginitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metronidazole 500 mg
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will receive placebo
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Intervention Description
Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants in this arm will receive placebo
Primary Outcome Measure Information:
Title
Evaluating Composite of Chorioamnionitis, Postpartum Endometritis, SSI, Wound Infection, or Other Post-cesarean Infections (Occurring Within 6 Weeks After Delivery)
Time Frame
Through study completion, approximately 9.5 months
Secondary Outcome Measure Information:
Title
Evaluating Incidence of Individual Infections.
Description
Chorioamnionitis, endometritis, wound infection (including necrotizing fascitis), other infections including abscess, septic thrombosis, pneumonia, pyelonephritis and breast infection.
Time Frame
At the time of admission for labor trough study completion, approximately 9.5 months
Title
Evaluating Incidence of Maternal Death
Time Frame
After delivery through study completion, approximately 9.5 months
Title
Evaluating Incidence of Puerperal Fever.
Description
Temperature > 100.4 F at least twice 30 minutes apart, or once with the use of antipyretic, or ≥101 F once.
Time Frame
Through study completion, approximately 9.5 months
Title
Evaluating Incidence of Use of Resources.
Description
Hospital stay, postpartum clinic or emergency room visit within 4 weeks of delivery, need for imaging or other invasive procedures, postpartum antibiotic use.
Time Frame
Through study completion, approximately 9.5 months
Title
Evaluating Incidence of Adverse Events
Description
Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis), GI symptoms (nausea, vomiting, diarrhea, constipation, ileus, etc)
Time Frame
Through study completion, approximately 9.5 months
Title
Evaluating Incidence of Suspected Sepsis for Newborns
Time Frame
Within 7 days of delivery
Title
Evaluating Incidence of Confirmed Sepsis for Newborns
Time Frame
Within 7 days of delivery
Title
Evaluating Incidence of Newborn Intensive Care Unit (NICU) Admission and Duration
Time Frame
After delivery through study completion, approximately 9.5 months
Title
Evaluating Incidence of Neonatal Morbidities
Time Frame
After delivery through study completion, approximately 9.5 months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Randomized Controlled Trial of Treatment of Bacterial Vaginosis
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