NCT03364491

Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean

Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean Delivery: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 11,000 (actual)
• Sponsor: The George Washington University Biostatistics Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Obstetrical hemorrhage is a common cause of maternal morbidity and mortality worldwide. The frequency and severity of hemorrhage is significantly higher after cesarean delivery than vaginal delivery. Recent evidence has emerged about the importance of the fibrinolytic pathway in the pathophysiology of hemorrhage in different clinical scenarios including trauma-associated bleeding, cardiovascular surgery, and obstetrical hemorrhage. Tranexamic acid (TXA) inhibits fibrinolysis and is used routinely to prevent hemorrhage in trauma cases and high risk surgeries. Randomized trials of TXA as a prophylaxis to prevent hemorrhage in cesarean delivery have been small and of mixed quality; however meta-analysis suggests that it is effective. This study is 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.

Conditions

• Obstetrical Complications
• Hemorrhage
• Labor and Delivery

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	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)
DRUG	Placebo	50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)

Timeline

• Start date: 2018-03-15
• Primary completion: 2021-07-24
• Completion: 2021-10-29
• First posted: 2017-12-06
• Last updated: 2023-02-21
• Results posted: 2023-01-19

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study