The WOMAN Trials have a simple aim. To ensure a safe childbirth for all women everywhere. These global 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 is currently investigating whether TXA can prevent women developing PPH in the first place. This trial will recruit 15,000 women giving birth vaginally with anaemia. The trial results will be published in 2023.
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.
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. I'M WOMAN, which follows on from the Phase 2 WOMAN-PharmacoTXA trial of 120 women in Pakistan and Zambia, will start recruiting 30,000 women in 2023.
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