Using tranexamic acid to prevent heavy bleeding after childbirth in at-risk women
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
Run by London School of Hygiene and Tropical Medicine · NCT05562609 · Data updated 2026-11-12
This study is testing if giving tranexamic acid before delivery can help prevent heavy bleeding after childbirth in women who are at higher risk.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 40000 (estimated) |
| Sponsor | London School of Hygiene and Tropical Medicine Academic / other |
| Locations | 1 site (Mbeya) |
| Status | Recruiting |
| Started | April 22, 2024 |
| Main results expected | September 2027 |
| Study ends | October 2027 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT05562609 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 and older who are admitted for childbirth and have one or more known risk factors for postpartum hemorrhage.
✕Probably not a fit
Patients who have clear contraindications for tranexamic acid will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial investigates the use of tranexamic acid (TXA) to prevent postpartum hemorrhage (PPH) in women who are at higher risk during childbirth. It aims to determine the effectiveness of TXA when administered just before delivery, comparing both intramuscular and intravenous routes. Given the significant maternal mortality associated with PPH, the study seeks to provide critical evidence on the benefits and potential side effects of early TXA administration. The trial will involve women aged 18 and older with known risk factors for PPH, assessing maternal health outcomes and bleeding control.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postpartum hemorrhage and related maternal deaths.
How similar studies have gone: Previous studies have shown that tranexamic acid can effectively reduce bleeding in postpartum situations, but this specific preventive approach is still being evaluated.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Mbeya Regional Referral Hospital
Mbeya, Tanzania Recruiting
Study contacts
- Study coordinator: Judith Lieber
- Email: imwoman@lshtm.ac.uk
- Phone: +44 (0)20 7958 8283
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.