Alternative Routes for Tranexamic Acid Treatment in Obstetric Bleeding (WOMAN-PharmacoTXA Trial): A Randomized Trial and Pharmacological Study in Cesarean Section Births

Abstract

(BJOG. 2023;130(10):1177–1186) Many maternal deaths due to severe postpartum bleeding (PPH) occur in middle-income or low-income countries. A widely practiced method for reducing postpartum bleeding is administration of tranexamic acid (TXA); methods of administration vary, with the drug being available as an intravenous (IV) infusion, intramuscular (IM) injection, and oral solution. The previous WOMAN-PharmacoTXA trial showed that IV TXA administered within 3 hours of delivery reduced PPH deaths by one-third, but IV administration is a barrier for care in low-income and middle-income countries. Therefore, it is important that such other administration options for such an integral lifesaving medication be evaluated in settings where IV infusion is difficult or impossible. This study was designed to evaluate the population pharmacokinetics (PK) and pharmacodynamics (PD) of TXA administered by IV infusion, IM injection, and oral routes in women having cesarean delivery (CD). This included evaluation of safety, adverse events, the concentration of TXA that crosses the placenta and its clearance, and the effect of administration route on D-dimer concentration.