Update 02/2021: As of the 19 of February 2021, 51 participants have been recruited in Zambia and Pakistan.
Update 12/2020: Recruitment for Woman-PharmacoTXA trial begins today 18th December 2020. Huge congratulations to all involved!
The WOMAN-PharmacoTXA trial is a randomised controlled trial to assess the pharmacokinetics and pharmacodynamics of intramuscular, intravenous, and oral administration of tranexamic acid in women giving birth by caesarean section
The WOMAN trial was successful in showing that intravenous TXA reduces premature death for treatment of Postpartum Haemorrhage (PPH) for women in labour by one-third if TXA is administered within 3 hours.
Most PPH deaths occur in the first hours after giving birth and treatment delay decreases survival. One barrier to rapid TXA treatment is the need for intravenous (IV) injection, as trained medical personnel are not always available when the emergency occurs. Intramuscular (IM) injection and oral solution of TXA would be easier and faster to administer and would require less training than IV use. However, the pharmacokinetics (PK), pharmacodynamics and safety of TXA administered by different routes in pregnant women have not yet been established.
The main aim of this study is to ascertain whether IM and oral solution of TXA will be well absorbed at levels sufficient to inhibit fibrinolysis in pregnant women.
This trial looks to better and make maternal healthcare accessible for mothers worldwide.
Interested to learn more?