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The WOMAN trial: clinical and contextual factors surrounding the deaths of 483 women following post-partum haemorrhage in developing countries

Clinical Trials Unit, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. roberto.picetti@lshtm.ac.uk. Clinical Trials Unit, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. Maternity Unit, Kumba District Hospital, Kumba, Southwest Province, Cameroon. Holy Family Hospital, Gynaecology & Obstetrics Unit 1, F-762 Said Pur Road, Satellite Town, Rawalpindi, Pakistan. Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Khartoum, Khartoum, Sudan. Department of Obstetrics and Gynaecology, School of Medicine, University of Zambia, Lusaka, Zambia. St George's University of London, Room 1.126, First Floor, Jenner Wing, Cranmer Terrace, London, SW17 0RE, UK.

BMC Pregnancy Childbirth. 2020;20(1):409
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PICO Summary

Population

Women with postpartum haemorrhage (PPH) in 193 centres in 21 countries enrolled in the international WOMAN trial (n= 20,060).

Intervention

Intravenous injection of 1 g of tranexamic acid (n= 10,051).

Comparison

Matching placebo (n= 10,009).

Outcome

There were 483 maternal deaths in developing countries. Case fatality rates were 3.0% in Africa and 1.7% in Asia. Nearly three quarters of deaths were within 3 hours of delivery and 91% of these deaths were from bleeding. Women who delivered outside a participating hospital (12%) were three times more likely to die than those who delivered in hospital. Key contributory factors highlighted by clinicians were: late presentation, maternal anaemia and poor infrastructure.
Abstract
BACKGROUND Post-partum haemorrhage (PPH) is a leading cause of maternal death worldwide. The WOMAN trial assessed the effects of tranexamic acid (TXA) on death and surgical morbidity in women with PPH. The trial recorded 483 maternal deaths. We report the circumstances of the women who died. METHODS The WOMAN trial recruited 20,060 women with a clinical diagnosis of PPH after a vaginal birth or caesarean section. We randomly allocated women to receive TXA or placebo. When a woman died, we asked participating clinicians to report the cause of death and to provide a short narrative of the events surrounding the death. We collated and edited for clarity the narrative data. RESULTS Case fatality rates were 3.0% in Africa and 1.7% in Asia. Nearly three quarters of deaths were within 3 h of delivery and 91% of these deaths were from bleeding. Women who delivered outside a participating hospital (12%) were three times more likely to die (OR = 3.12, 95%CI 2.55-3.81) than those who delivered in hospital. Blood was often unavailable due to shortages or because relatives could not afford to buy it. Clinicians highlighted late presentation, maternal anaemia and poor infrastructure as key contributory factors. CONCLUSIONS Although TXA use reduces bleeding deaths by almost one third, mortality rates similar to those in high income countries will not be achieved without tackling late presentation, maternal anaemia, availability of blood for transfusion and poor infrastructure.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine