CompletedPhase 3

Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean

United States11,000 participantsStarted 2018-03-15

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Scheduled or unscheduled cesarean delivery
✓. Singleton or twin gestation

Exclusion criteria

✕. Age less than 18 years
✕. Transfusion or planned transfusion of any blood products during the current admission because the primary outcome is already pre-determined and the need for transfusion will be unrelated to perioperative hemorrhage
✕. Recent diagnosis or history of venous thromboembolism or arterial thrombosis because TXA is a risk factor for thromboembolism, and its use is contraindicated
✕. Known congenital or acquired thrombophilias, including antiphospholipid antibody syndrome, because of the increased risk of thrombosis
✕. Seizure disorder (including eclampsia) because TXA is a GABA receptor antagonist, and its use has been associated with postoperative seizures
✕. Serum creatinine 1.2 or higher or on dialysis, with renal disease, or a history of renal insufficiency, because TXA is substantially excreted by the kidney, and impaired renal function may increase the risk of toxic reactions.
✕. Sickle cell disease, because of substantial use of perioperative transfusion unrelated to hemorrhage. Sickle cell trait is not an exclusion per se.
✕. Autoimmune diseases such as lupus, rheumatoid arthritis, Sjogren's disease, and inflammatory bowel disease because of hypercoagulability and the increased risk of thrombosis or thromboembolism

What they're measuring

Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells

Timeframe: by hospital discharge or by 7 days postpartum, whichever is sooner

Trial details

NCT IDNCT03364491

SponsorThe George Washington University Biostatistics Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-24

Results submitted2022-11-16

View on ClinicalTrials.gov More Obstetrical Complications trials