If you would like to find out more about WOMAN-PharmacoTXA, please email us at ctu@lshtm.ac.uk.
Overview
WOMAN-PharmacoTXA was an open label, randomised controlled trial and pharmacological study in caesarean section births that investigated alternative routes for tranexamic acid (TXA) treatment in obstetric bleeding.
The trial, which published its results in 2023, showed that intramuscular (IM) administration of TXA is safe and quickly reaches therapeutic concentrations in pregnant women and may be a suitable alternative to intravenous TXA.
Intramuscular tranexamic acid
The need for an intravenous (IV) injection is an important barrier to timely TXA treatment. Health workers able to give IV drugs are unavailable in some rural health centres for many homebirths. Even when available, IV cannulation can be difficult in shocked patients with collapsed veins.
TXA tablets are available, but dissolution and absorption take time and are incomplete, limiting oral bioavailability.
IM injection or oral administration of the intravenous solution might achieve therapeutic TXA blood concentrations more rapidly.
The investigators aimed to assess the population pharmacokinetics and pharmacodynamics of intravenous, intramuscular and oral TXA in women undergoing caesarean section with at least one known risk factor for postpartum haemorrhage.
Trial in numbers
120
Participants recruited
2
Recruiting countries
3
Hospitals
Results
The trial found that IM TXA is well tolerated and rapidly absorbed in pregnant women. IM administration of one gramme of TXA achieves a therapeutic blood concentration within 10 minutes of injection, which is less than the time it takes to give the IV dose, and remains above this concentration for over four hours.
Oral administration of four grams of TXA was well tolerated, but it took close to an hour to achieve therapeutic concentrations. As women with severe obstetric bleeding can die within hours of bleeding onset, the IM route is a potential alternative to IV administration, but the oral route is not suitable for emergency treatment.
These findings provide sufficient information for a future trial to test whether the IM route of administration is as effective as the IV route in reducing postpartum bleeding. The I’M WOMAN Trial is now doing this.
Full publication
Trial protocol
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