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NCT03364491 · ClinicalTrials.gov registry record · Phase 3
Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean
A Phase 3 study, sponsored by The George Washington University Biostatistics Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 11,000
- Enrollment target
NCT03364491: Completed Phase 3 study, sponsored by The George Washington University Biostatistics Center.
NCT03364491 is a Phase 3 study that has completed, run by The George Washington University Biostatistics Center. The registered enrollment target is 11,000 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1327% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03364491, a Phase 3 study, has completed, sponsored by The George Washington University Biostatistics Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 11,000 participants
- Enrollment target
Study Summary
A randomized placebo-controlled trial of 11,000 women to assess whether tranexamic acid as prophylaxis lowers the risk of postpartum hemorrhage in women undergoing a cesarean delivery.
Primary Outcome
Participants were monitored from delivery until hospital discharge or 7 days after delivery (postpartum), whichever is sooner. This is the number of mothers who died for any reason, or had a blood transfusion of 1 or more units (of packed red blood cells, including whole blood or cell saver).
Interventions
- DRUG Placebo
- DRUG Tranexamic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11,000 participants |
| Start Date | 2018-03-15 |
| Est. Completion | 2021-10-29 |
| Phase | Phase 3 |
What the finished NCT03364491 record still lists
NCT03364491 is an interventional study that assigns participants to a tested intervention. Its 11,000 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1327% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03364491 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03364491 about?
NCT03364491 is a clinical study titled "Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean". A randomized placebo-controlled trial of 11,000 women to assess whether tranexamic acid as prophylaxis lowers the risk of postpartum hemorrhage in women undergoing a cesarean delivery.
What is the current status of trial NCT03364491?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 11,000 participants. The study started on 2018-03-15. Estimated completion is 2021-10-29.
What interventions are being tested in trial NCT03364491?
The interventions under investigation include: Placebo (DRUG), Tranexamic Acid (DRUG).
Who is sponsoring clinical trial NCT03364491?
This trial is sponsored by The George Washington University Biostatistics Center, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03364491's enrollment target sits among peer trials
11,000 22nd of 2000 higher than 1,976 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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