The I’M WOMAN Trial is a randomised, placebo-controlled trial assessing the effects of intramuscular (IM) and intravenous (IV) tranexamic acid (TXA) in women at increased risk of postpartum haemorrhage (PPH).
The WOMAN-2 Trial results highlighted that giving TXA intravenously within 15 minutes after umbilical cord clamping does not prevent a clinical diagnosis of PPH in anaemic women. The I’M WOMAN Trial is looking to see if giving TXA earlier, before birth, to women with a higher risk of PPH, including women with anaemia, can maximise the benefits of TXA and reduce severe postpartum bleeding.
Find active updates and full details of the trial on the IM WOMAN Trial website.
PPH, or severe bleeding after childbirth, kills tens of thousands of mothers every year. Factors such as anaemia, high blood pressure, an unusual placenta, or a long or difficult labour can increase the chances of women having a PPH.
In 2017, the WOMAN Trial found that TXA reduces death from bleeding and the need for surgery to control bleeding by about one third when given to women with PPH within three hours of birth.
TXA is usually given by slow IV injection, but this route of administration is a major access barrier. Recent research shows that TXA is well tolerated and rapidly absorbed after IM injection, achieving therapeutic blood levels within minutes of injection. The I’M WOMAN Trial is now generating evidence on whether giving TXA intramuscularly is as effective as giving it intravenously.
There may be fewer side effects with IM TXA because peak blood concentrations are lower than with the IV route. IM TXA also has practical advantages as it is quicker and simpler to administer.
The trial is also investigating whether giving TXA earlier, before birth, can prevent severe bleeding after childbirth.
The trial recruitment has started and will recruit a total of 30,000 women. Check out the participant information section for more details.
If you would like to find out more about the I’M WOMAN Trial, please email us at imwoman@lshtm.ac.uk.
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