Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean
Condition: Obstetrical Complications; Hemorrhage; Labor and Delivery
MeSH terms: Hemorrhage
Intervention: Tranexamic Acid; Placebo
Intervention description: 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); 50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to receive either TXA (1 gram [10cc] mixed with 40 cc of normal saline) administered intravenously or a placebo control of 50 cc of normal saline administered intravenously
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The patient nor the clinical staff will be aware of the treatment assignment. The TXA or placebo solutions will be prepared by the center research pharmacies.
Enrollment: 11000.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tranexamic Acid; Hemorrhage; Cesarean

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Scheduled or unscheduled cesarean delivery

          2. Singleton or twin gestation

        Exclusion Criteria:

          1. Age less than 18 years

          2. 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

          3. Recent diagnosis or history of venous thromboembolism or arterial thrombosis because
             TXA is a risk factor for thromboembolism, and its use is contraindicated

          4. Known congenital or acquired thrombophilias, including antiphospholipid antibody
             syndrome, because of the increased risk of thrombosis

          5. Seizure disorder (including eclampsia) because TXA is a GABA receptor antagonist, and
             its use has been associated with postoperative seizures

          6. 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.

          7. Sickle cell disease, because of substantial use of perioperative transfusion unrelated
             to hemorrhage. Sickle cell trait is not an exclusion per se.

          8. 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

          9. Need for therapeutic dose of anticoagulation before delivery, because the risk of
             thrombosis may be increased with TXA

         10. Treatment with clotting factor concentrates, because the risk of thrombosis may be
             increased with TXA

         11. Presence of frank hematuria, because the risk of ureteral obstruction in those with
             upper urinary tract bleeding may be increased with TXA

         12. Patient refusal of blood products because the primary outcome is then pre-determined

         13. Receipt of TXA; or planned or expected use of TXA prophylaxis

         14. Active cancer, because of risk of thromboembolism

         15. Congestive heart failure requiring treatment, because of risk of thrombosis

         16. History of retinal disease, because the risk of central retinal artery or vein
             obstruction may be increased with TXA

         17. Acquired defective color vision or subarachnoid hemorrhage, since TXA is
             contraindicated

         18. Hypersensitivity to TXA or any of the ingredients

         19. No hemoglobin result available from the last 4 weeks, since it is necessary to measure
             the post-operative change in hemoglobin

         20. Scheduled cesarean delivery and quota for scheduled deliveries already met. Quotas on
             the number of scheduled and unscheduled deliveries will be placed to ensure
             approximately equal distribution of scheduled and unscheduled cesarean deliveries.

         21. Participation in this trial in a previous pregnancy. Patients who were screened in a
             previous pregnancy, but not randomized, may be included.

         22. Participating in another intervention study where the primary outcome includes
             postpartum bleeding or thromboembolism, or the study intervention directly affects
             postpartum bleeding or thromboembolism

         23. Receipt of uterotonics, other than oxytocin, or planned or expected use of uterotonic
             prophylaxis

         24. Symptomatic for COVID-19 infection within 14 days prior to delivery