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COMPLETED
NCT03364491
PHASE3

Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean

Sponsor: The George Washington University Biostatistics Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

11000

Start Date

2018-03-15

Completion Date

2021-10-29

Last Updated

2026-06-25

Healthy Volunteers

No

Interventions

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)

Locations (12)

University of Alabama - Birmingham

Birmingham, Alabama, United States

Northwestern University-Prentice Hospital

Chicago, Illinois, United States

Columbia University

New York, New York, United States

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Case Western Reserve-MetroHealth

Cleveland, Ohio, United States

Ohio State University Hospital

Columbus, Ohio, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Brown University

Providence, Rhode Island, United States

University of Texas Medical Branch

Galveston, Texas, United States

University of Texas - Houston

Houston, Texas, United States

University of Utah Medical Center

Salt Lake City, Utah, United States