The WOMAN Trials have a simple aim. To ensure a safe childbirth for all women everywhere. These global clinical trials are producing the evidence needed to stop women dying in childbirth. Heavy bleeding after childbirth, called a postpartum haemorrhage or PPH, is the main cause of maternal death, killing tens of thousands of mothers every year. The WOMAN Trials are looking at the effect of the drug tranexamic acid (TXA) on bleeding and the best ways to give it.
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 postpartum haemorrhage within three hours of birth. There were no adverse effects for mothers or babies. The trial recruited over 20,000 women worldwide.
The WOMAN-2 Trial enrolled over 15,000 women with moderate or severe anaemia across Nigeria, Tanzania, Zambia and Pakistan. It examined whether TXA given within 15 minutes of the umbilical cord being clamped after birth could prevent clinically diagnosed PPH. The results, published in 2024, showed that women with moderate and severe anaemia had a much higher risk of PPH, but there was no reduction in the risk of PPH with TXA.
The I’M WOMAN Trial, part of the TRANSFORM project, is looking at easier and more accessible ways to give TXA – intramuscularly, rather than intravenously – with the aim of expanding access to timely TXA treatment. The trial is underway and will finish recruiting 30,000 women in 2025.
If TXA could be given intramuscularly, women giving birth outside of hospitals would have access to this lifesaving drug and healthcare workers would be able treat women faster. This is crucial when a woman can bleed to death in a matter of minutes.
The WOMAN-3 Trial, which will start recruiting soon, will examine the role of giving TXA during menstruation alongside the usual iron and multivitamins to treat anaemia.
The team is also conducting further research into who should receive TXA and its cost-effectiveness.
Find out more about our growing body of work on The Blood Trials website.
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