Intervention: Tranexamic acid
Trial phase: Phase 3
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5529
Group description: Tranexamic Acid for intravenous administration

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)
Eligibility criteria:
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
Need for therapeutic dose of anticoagulation before delivery, because the risk of thrombosis may be increased with TXA
Treatment with clotting factor concentrates, because the risk of thrombosis may be increased with TXA
Presence of frank hematuria, because the risk of ureteral obstruction in those with upper urinary tract bleeding may be increased with TXA
Patient refusal of blood products because the primary outcome is then pre-determined
Receipt of TXA; or planned or expected use of TXA prophylaxis
Active cancer, because of risk of thromboembolism
Congestive heart failure requiring treatment, because of risk of thrombosis
History of retinal disease, because the risk of central retinal artery or vein obstruction may be increased with TXA
Acquired defective color vision or subarachnoid hemorrhage, since TXA is contraindicated
Hypersensitivity to TXA or any of the ingredients
No hemoglobin result available from the last 4 weeks, since it is necessary to measure the post-operative change in hemoglobin
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.
Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.
Participating in another intervention study where the primary outcome includes postpartum bleeding or thromboembolism, or the study intervention directly affects postpartum bleeding or thromboembolism
Receipt of uterotonics, other than oxytocin, or planned or expected use of uterotonic prophylaxis
Symptomatic for COVID-19 infection within 14 days prior to delivery