Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women At Higher Risk
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
London School of Hygiene and Tropical Medicine
30,000 participants
Apr 22, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria1
- Women aged 18 years or older who are admitted to hospital to give birth vaginally or by caesarean section, who have one or more known risk factors for PPH
Exclusion Criteria1
- Women who have a clear indication or contraindication for TXA
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Interventions
Ampoules and packaging for all arms will be identical in appearance.
Ampoules and packaging for all arms will be identical in appearance.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05562609