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NCT03954990
Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity
Phase 1 trial testing Metronidazole Oral in Bacterial Vaginoses in 75 participants. Terminated before completion.
26 September 2022
Quick facts
| Lead sponsor | The University of Texas Medical Branch, Galveston |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 75 |
| Start date | 11 October 2019 |
| Primary completion | 26 September 2022 |
| Estimated completion | 26 September 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Metronidazole Oral
- Placebo Oral Tablet — full drug profile →
Conditions studied
- Bacterial Vaginoses — all drugs for Bacterial Vaginoses →
Sponsor
The University of Texas Medical Branch, Galveston
Who can join
Adults 18 to 50, female only, with Bacterial Vaginoses. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Bacterial vaginosis (BV) is the most common cause of vaginal discharge among repro-ductive aged women. It is been linked to adverse maternal and neonatal outcomes. Our objective is to evaluate if the use of a single dose of metronidazole in women with BV at time of delivery reduces infectious morbidities
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03954990
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Metronidazole Oral
Trials testing the same drug.
- NCT06135974 — Vaginal lIve Biotherapeutic RANdomized Trial · EARLY_PHASE1 · completed
- NCT05748145 — Metronidazole as Preoperative Therapy in CRC / FusoMetro-001 · Phase 2 · recruiting
- NCT03593252 — Bowel Preparation in Elective Pediatric Colorectal Surgery · NA · unknown
- NCT05788991 — Comparison of Dequalinium Chloride (Fluomizin) vs Oral Metronidazole for the Treatment of Bacterial Vaginosis · Phase 4 · terminated
- NCT04682522 — Flagyl Microbiome in Crohn's Disease · Phase 4 · completed
Other recruiting trials for Bacterial Vaginoses
Currently open trials in the same condition.
- NCT04807842 — Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis · NA · recruiting
Other The University of Texas Medical Branch, Galveston trials
Trials by the same sponsor.
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- NCT07203287 — Risk of Acute Complications With Rocuronium vs Cisatracurium in Patients With Chronic Kidney Disease · Phase 4 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03954990 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston
- Last refreshed: 12 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03954990.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing