Preventing Heavy Bleeding After Childbirth with Tranexamic Acid Given by Injection in Women at Higher Risk

What this Trial Is About

Postpartum haemorrhage PPH is a serious cause of maternal deaths worldwide, causing about 70,000 deaths each year. Researchers are evaluating whether giving tranexamic acid TXA just before childbirth can prevent PPH in women who are at higher risk. This Phase 3 trial compares the effects of TXA administered by two different routes, intramuscular IM and intravenous IV, on the occurrence of PPH, side effects, and other important health outcomes for mothers. Participants will be randomly assigned to one of three groups one receiving 1 gram of TXA by two intramuscular injections plus a placebo IV injection, another receiving 1 gram of TXA by slow IV injection plus placebo IM injections, and a third group receiving placebo injections both IM and IV. The packaging and appearance of the TXA and placebo ampoules are identical, and the trial uses a double-blind design. This setup allows the study to evaluate both the effectiveness and tolerability of the two TXA administration methods. Women aged 18 years or older who are admitted to the hospital to give birth vaginally or by caesarean section and who have one or more risk factors for PPH may participate. During the study, researchers will monitor participants for the occurrence of PPH within 24 hours after childbirth and assess side effects and maternal health outcomes. The trial will carefully track participant health and safety throughout the study period, which is expected to continue until September 2025.

Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women At Higher Risk