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.
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
Women who have a clear indication or contraindication for TXA
Parallel
Tranexamic acid
DrugAmpoules and packaging for all arms will be identical in appearance.
Placebo
Other interventionAmpoules and packaging for all arms will be identical in appearance.
Risk of Postpartum haemorrhage
Clinical assessment: This may be an estimated blood loss of more than 500 mL in vaginal births or more than 1000 ml in caesarean births, or any blood loss sufficient to compromise haemodynamic stability. Haemodynamic instability is based on clinical judgement and assessed using clinical signs (low systolic blood pressure, tachycardia, reduced urine output)
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London School of Hygiene and Tropical Medicine
Lead sponsor
UNITAID
Collaborator
