Bacterial Vaginoses
Conditions
Keywords
Bacterial Vaginoses, Cesarean delivery, Surgical site infection, Endometritis, Infection, Vaginitis
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.
Interventions
DRUGMetronidazole
Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days
DRUGPlacebo
Participants in this arm will receive placebo
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluating Incidence of Maternal Death | After delivery through study completion, approximately 9.5 months | — |
| Evaluating Incidence of Puerperal Fever. | Through study completion, approximately 9.5 months | 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. | Through study completion, approximately 9.5 months | 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 | Through study completion, approximately 9.5 months | Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis), GI symptoms (nausea, vomiting, diarrhea, constipation, ileus, etc) |
| Evaluating Incidence of Individual Infections. | At the time of admission for labor trough study completion, approximately 9.5 months | Chorioamnionitis, endometritis, wound infection (including necrotizing fascitis), other infections including abscess, septic thrombosis, pneumonia, pyelonephritis and breast infection. |
| 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 | — |
| Evaluating Incidence of Suspected Sepsis for Newborns | Within 7 days of delivery | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Metronidazole 500 mg Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days
Metronidazole: Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days | 0 |
| Placebo Participants in this arm will receive placebo
Placebo: Participants in this arm will receive placebo | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
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
Population: Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study.
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)
Time frame: Through study completion, approximately 9.5 months
Population: Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study.
Secondary
Evaluating Incidence of Confirmed Sepsis for Newborns
Time frame: Within 7 days of delivery
Population: Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study.
Secondary
Evaluating Incidence of Individual Infections.
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
Population: Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study.
Secondary
Evaluating Incidence of Maternal Death
Time frame: After delivery through study completion, approximately 9.5 months
Population: Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study.
Secondary
Evaluating Incidence of Neonatal Morbidities
Time frame: After delivery through study completion, approximately 9.5 months
Population: Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study.
Secondary
Evaluating Incidence of Newborn Intensive Care Unit (NICU) Admission and Duration
Time frame: After delivery through study completion, approximately 9.5 months
Population: Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study.
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.
Time frame: Through study completion, approximately 9.5 months
Population: Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study.
Secondary
Evaluating Incidence of Suspected Sepsis for Newborns
Time frame: Within 7 days of delivery
Population: Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study.
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.
Time frame: Through study completion, approximately 9.5 months
Population: Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study.