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RECRUITING
NCT05562609
PHASE3

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

Sponsor: London School of Hygiene and Tropical Medicine

View on ClinicalTrials.gov

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

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.

Locations (1)

Mbeya Regional Referral Hospital

Mbeya, Tanzania