A Phase 4 interventional study of Metronidazole and Placebo in Bacterial Vaginoses, sponsored by Ohio State University. Terminated at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-06-15.
Sponsored by Ohio State University · Phase 4, Interventional, and Treatment
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.
228 studies on the registry are indexed under Vaginosis, Bacterial; 39 are open to participants now.
This study's enrollment of 16 is below the median of 100 across 194 interventional studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →Ohio State University is the lead sponsor of 658 studies on the registry; 145 are open to participants now.
Of its 66 completed or terminated interventional studies of FDA-regulated products, 49 (74%) have results posted.
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Exclusion Criteria:
Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days
Drug: Metronidazole
Participants in this arm will receive placebo
Drug: Placebo
Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days
Participants in this arm will receive placebo
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
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
Evaluating Incidence of Maternal Death
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: Through study completion, approximately 9.5 months
Evaluating Incidence of Suspected Sepsis for Newborns
Time frame: Within 7 days of delivery
Evaluating Incidence of Confirmed Sepsis for Newborns
Time frame: Within 7 days of delivery
Evaluating Incidence of Newborn Intensive Care Unit (NICU) Admission and Duration
Time frame: After delivery through study completion, approximately 9.5 months
Evaluating Incidence of Neonatal Morbidities
Time frame: After delivery through study completion, approximately 9.5 months
| Milestone | Metronidazole 500 mg | Placebo |
|---|---|---|
| Started | 8 | 8 |
| Completed | 0 | 0 |
| Not completed | 8 | 8 |
No measurements were reported for this outcome.
Chorioamnionitis, endometritis, wound infection (including necrotizing fascitis), other infections including abscess, septic thrombosis, pneumonia, pyelonephritis and breast infection.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Temperature \> 100.4 F at least twice 30 minutes apart, or once with the use of antipyretic, or ≥101 F once.
No measurements were reported for this outcome.
Hospital stay, postpartum clinic or emergency room visit within 4 weeks of delivery, need for imaging or other invasive procedures, postpartum antibiotic use.
No measurements were reported for this outcome.
Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis), GI symptoms (nausea, vomiting, diarrhea, constipation, ileus, etc)
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over Through study termination. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Metronidazole 500 mg | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Placebo | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
Baseline analysis population data was not obtained as participants assigned to the treatment and placebo group did not complete the study, and this study was terminated due to lack of participant enrollment before data could be collected. No baseline data was collected.
| Age, Categorical | Metronidazole 500 mg | Placebo | Total |
|---|---|---|---|
| <=18 years | — | — | — |
| Between 18 and 65 years | — | — | — |
| >=65 years | — | — | — |
| Age, Continuous | Metronidazole 500 mg | Placebo | Total |
|---|
| Sex: Female, Male | Metronidazole 500 mg | Placebo | Total |
|---|---|---|---|
| Female | — | — | — |
| Male | — | — | — |
| Race and Ethnicity Not Collected | Metronidazole 500 mg | Placebo | Total |
|---|
| Region of Enrollment(participants) | Metronidazole 500 mg | Placebo | Total |
|---|
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Apr 2021 to primary completion in Feb 2022, 9 months.
Results were first posted in Jun 2023, 1 year 4 months after primary completion.
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This study is terminated, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Metronidazole