Using tranexamic acid to prevent heavy bleeding after childbirth in at-risk women
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
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 |
| Enrollment | 30000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | London School of Hygiene and Tropical Medicine Academic / other |
| Locations | 1 site (Mbeya) |
| Trial ID | NCT05562609 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who have clear contraindications for tranexamic acid will not benefit from this study.
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 performed: Previous studies have shown that tranexamic acid can effectively reduce bleeding in postpartum situations, but this specific preventive approach is still being evaluated.
Eligibility criteria
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
Where this trial is running
Mbeya
- Mbeya Regional Referral Hospital — Mbeya, Tanzania (Recruiting)
Study contacts
- Study coordinator: Amy Brenner
- Email: imwoman@lshtm.ac.uk
- Phone: +44 (0)20 7958 8283
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.