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NCT04578015 · ClinicalTrials.gov registry record · Phase 4
A Randomized Controlled Trial of Treatment of Bacterial Vaginosis
A Phase 4 study, sponsored by Ohio State University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
NCT04578015: Clinical Trial Phase 4 study, sponsored by Ohio State University.
NCT04578015 is a Phase 4 study that was terminated before completion, run by Ohio State University. The registered enrollment target is 16 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04578015, a Phase 4 study, was terminated before completion, sponsored by Ohio State University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
Study 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
- DRUG Placebo
- DRUG Metronidazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2021-04-26 |
| Est. Completion | 2022-02-09 |
| Phase | Phase 4 |
Why NCT04578015 stopped before completion
NCT04578015 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04578015 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04578015 about?
NCT04578015 is a clinical study titled "A Randomized Controlled Trial of Treatment of Bacterial Vaginosis". 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 a...
What is the current status of trial NCT04578015?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2021-04-26. Estimated completion is 2022-02-09.
What interventions are being tested in trial NCT04578015?
The interventions under investigation include: Placebo (DRUG), Metronidazole (DRUG).
Who is sponsoring clinical trial NCT04578015?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04578015's enrollment target sits among peer trials
16 1869th of 2000 higher than 121 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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