RecruitingPhase 3NCT05562609

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


Sponsor

London School of Hygiene and Tropical Medicine

Enrollment

30,000 participants

Start Date

Apr 22, 2024

Study Type

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

Sex: FEMALEMin Age: 18 Years

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

DRUGTranexamic acid

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

OTHERPlacebo

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


Locations(1)

Mbeya Regional Referral Hospital

Mbeya, Tanzania

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NCT05562609


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