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Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women At Higher Risk
Sponsor: London School of Hygiene and Tropical Medicine
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.
Official title: Tranexamic Acid by the Intramuscular or Intravenous Route for the Prevention of Postpartum Haemorrhage in Women At Increased Risk: a Randomised, Double-blind, Placebo-controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30000
Start Date
2024-04-22
Completion Date
2025-09
Last Updated
2025-03-11
Healthy Volunteers
No
Conditions
Interventions
Tranexamic acid
Ampoules and packaging for all arms will be identical in appearance.
Placebo
Ampoules and packaging for all arms will be identical in appearance.
Locations (1)
Mbeya Regional Referral Hospital
Mbeya, Tanzania