Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women At Higher Risk
Recruiting
Phase 3
Interventional Study
Postpartum Hemorrhage
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 30,000 (estimated)
- Sponsor
- London School of Hygiene and Tropical Medicine · Other
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About This Trial
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 a…
Trial Locations
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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
Contacts
Ian Roberts
+44 (0)20 7958 8128
CONTACT