Clinical Trial

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

Study acronym: I'M-WOMAN
Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated March 11, 2025 (before its estimated August 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-09-27; most recent amendment 2025-03-07.
Status change: Not Yet Recruiting → Recruiting 2024-04-24
Trial Details
NCT Number NCT05562609
Lead Sponsor London School of Hygiene and Tropical Medicine
Collaborators: UNITAID
Conditions Postpartum Hemorrhage
Enrollment 30,000 participants
Start Date 2024-04-22
Primary Completion 2025-08 (estimated)
Study Completion 2025-09 (estimated)
Updated on ClinicalTrials.gov 2025-03-11