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Recruiting
NCT05562609
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Conditions: Postpartum Hemorrhage
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 40000
Sponsor: London School of Hygiene and Tropical Medicine
Location: Mbeya Regional Referral Hospital Mbeya
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 Criteria
Inclusion Criteria:
* 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 Criteria:
* Women who have a clear indication or contraindication for TXA
* Women with ongoing antepartum haemorrhage
Source: ClinicalTrials.gov (NCT05562609). StuddyBuddy aggregates publicly available trial information.