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

Phase 3 Recruiting 30000 enrolled London School of Hygiene and Tropical Medicine UNITAID · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

Heavy bleeding after childbirth, known as a postpartum haemorrhage (PPH), causes about 70,000 maternal deaths every year. Tranexamic acid (TXA) is a lifesaving treatment for women with PPH. The I'M WOMAN trial is a research study to see whether giving TXA just before childbirth will stop women developing PPH. The trial will assess the effects of intramuscular (IM) and intravenous (IV) tranexamic acid on PPH, side effects and other important maternal health outcomes.

Timeline

Start: 2024-04-22
Primary completion: 2025-08
Completion: 2025-09

Publications

Larson NJ, Mergoum AM, Dries DJ, Cook A, Blondeau B, Rogers FB. THE ROLE OF TRANEXAMIC ACID IN POSTPARTUM HEMORRHAGE: A NARRATIVE REVIEW. Shock. 2024 Nov 1;62(5):620-627. doi: 10.1097/SHK.0000000000002455. Epub 2024 Aug 20.
Brenner A, Shakur-Still H, Chaudhri R, Muganyizi P, Olayemi O, Arribas M, Kayani A, Javid K, Bello A, Roberts I; I'M WOMAN Trial Collaborative Group. Tranexamic acid by the intramuscular or intravenous route for the prevention of postpartum haemorrhage in women at increased risk: a randomised placebo-controlled trial (I'M WOMAN). Trials. 2023 Dec 3;24(1):782. doi: 10.1186/s13063-023-07687-1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tranexamic Acid	Small molecule	1 g	Intramuscular

Indications

No indication recorded.