Overview
For over a decade, we have undertaken global clinical trials with the aim of reducing maternal mortality.
Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide. Every year, around 70,000 women die from severe bleeding after childbirth, mostly in sub-Saharan Africa and South Asia.
Additionally, over one-third of pregnant women in the world are anaemic and many are severely anaemic. These women have an increased risk of PPH and suffer more severe outcomes if PPH occurs.
These trials – the WOMAN Trials – are looking at the effect of the drug tranexamic acid (TXA) on bleeding, and the best ways to give it.
Her life matters
Findings so far
WOMAN Trial
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.
WOMAN-2
The results of the WOMAN-2 Trial were published in 2024 and showed, alongside an IPD meta-analysis, two important findings
- The meta-analysis of over 50,000 women showed that TXA substantially reduces life-threatening bleeding after childbirth, regardless of the type of birth (vaginal or caesarean) or the presence or absence of anaemia. The analysis showed that TXA cut the risk of life-threatening bleeding by nearly one quarter.
- The WOMAN-2 Trial results, which looked at over 15,000 women in Pakistan, Nigeria, Tanzania and Zambia, 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.
However, the WOMAN-2 Trial also showed that the more severe the anaemia, the higher the risk of PPH and the sooner after birth the PPH diagnosis is made. The trial found that 35% of PPH diagnoses were made before the trial treatment had been completed. It seems likely that many of these PPH diagnoses were made before TXA could have any effect. The trial also highlighted the need for better interventions to prevent and treat anaemia, which is pervasive and chronic in many countries.
The next phase
The I’M WOMAN Trial, part of the TRANSFORM project, which is currently recruiting patients in Nigeria, Tanzania, Pakistan and Ethiopia, 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 in Zambia, is currently recruiting 30,000 women.
To cut maternal deaths, we must prevent and treat anaemia in women of childbearing age.
The WOMAN-3 Trial, which will start recruiting in 2025, 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.
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