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

Study acronym: I'M-WOMAN
StatusRecruiting
PhasePhase 3
Started
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.

Record History

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  1. Study Identification, Study Status, Oversightv5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2023 to Apr 22, 2024
    • Study sites: 0 to 1
    v4
  3. Study title shortened, about 3 wordsv3
  4. Primary endpoint revised
    • Study description expanded, about 2 words
    • Study title shortened, about 2 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05562609
Lead Sponsor London School of Hygiene and Tropical Medicine
Collaborators: UNITAID
Conditions
(from sponsor)		 Postpartum Hemorrhage
Related terms Hemorrhage, Postpartum Hemorrhage
Enrollment 30,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov