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

NCT05562609 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30000

Last updated 2025-03-11

No results posted yet for this study

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.

Conditions

  • Postpartum Hemorrhage

Interventions

DRUG

Tranexamic acid

Ampoules and packaging for all arms will be identical in appearance.

OTHER

Placebo

Ampoules and packaging for all arms will be identical in appearance.

Sponsors & Collaborators

  • UNITAID

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Amy Brenner · London School oh Hygiene and Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-22
Primary Completion
2025-08-31
Completion
2025-09-30

Countries

  • Tanzania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05562609 on ClinicalTrials.gov