CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 11,000 enrolled / 11,000 target
Drug / intervention
Tranexamic Acid +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03364491
NCT03364491Phase 3CompletedHigh Momentum (110.5/mo)Completion was 59mo ago
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Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean Delivery: A Randomized Controlled Trial

The George Washington University Biostatistics Center·interventional·Posted Dec 6, 2017·Updated Jun 25, 2026

In Brief

A Phase 3 clinical trial evaluating Tranexamic Acid and Placebo for Obstetrical Complications and 2 related conditions. Completed, enrolled 11,000 participants across 12 sites.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObstetrical Complications, Hemorrhage, Labor and Delivery
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedDec 6, 2017
Enrollment StartMar 15, 2018
Primary CompletionJul 24, 2021
Study CompletionOct 29, 2021
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 8.6 years ago

Arms & Interventions

Tranexamic Acidexperimental

Tranexamic Acid for intravenous administration

Drug: Tranexamic Acid
Placeboplacebo_comparator

Normal saline for intravenous administration

Drug: Placebo

Interventions

Tranexamic Aciddrug

A single dose of Tranexamic Acid (1 gram) in normal saline for a total of 50cc, administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)

Placebodrug

50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)