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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 is a Phase 4 study that was terminated before completion, run by Ohio State University. The registered enrollment target is 16 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04578015
The ClinicalTrials.gov registry entry for NCT04578015 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04578015 reports 0 study locations.
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.
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