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

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...

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Main Authors: Roberto Picetti, Lori Miller, Haleema Shakur-Still, Tracey Pepple, Danielle Beaumont, Eni Balogun, Etienne Asonganyi, Rizwana Chaudhri, Mohamed El-Sheikh, Bellington Vwalika, Sabaratnam Arulkumaran, Ian Roberts, on behalf of the WOMAN trial collaborators
Format: Article
Language:English
Published: BMC 2020-07-01
Series:BMC Pregnancy and Childbirth
Online Access:http://link.springer.com/article/10.1186/s12884-020-03091-8
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author Roberto Picetti
Lori Miller
Haleema Shakur-Still
Tracey Pepple
Danielle Beaumont
Eni Balogun
Etienne Asonganyi
Rizwana Chaudhri
Mohamed El-Sheikh
Bellington Vwalika
Sabaratnam Arulkumaran
Ian Roberts
on behalf of the WOMAN trial collaborators
author_facet Roberto Picetti
Lori Miller
Haleema Shakur-Still
Tracey Pepple
Danielle Beaumont
Eni Balogun
Etienne Asonganyi
Rizwana Chaudhri
Mohamed El-Sheikh
Bellington Vwalika
Sabaratnam Arulkumaran
Ian Roberts
on behalf of the WOMAN trial collaborators
author_sort Roberto Picetti
collection DOAJ
description 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.
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spelling doaj.art-4d4e54c0327740709061a925ecaf1e0d2022-12-21T18:58:19ZengBMCBMC Pregnancy and Childbirth1471-23932020-07-012011910.1186/s12884-020-03091-8The WOMAN trial: clinical and contextual factors surrounding the deaths of 483 women following post-partum haemorrhage in developing countriesRoberto Picetti0Lori Miller1Haleema Shakur-Still2Tracey Pepple3Danielle Beaumont4Eni Balogun5Etienne Asonganyi6Rizwana Chaudhri7Mohamed El-Sheikh8Bellington Vwalika9Sabaratnam Arulkumaran10Ian Roberts11on behalf of the WOMAN trial collaboratorsClinical Trials Unit, London School of Hygiene & Tropical MedicineClinical Trials Unit, London School of Hygiene & Tropical MedicineClinical Trials Unit, London School of Hygiene & Tropical MedicineClinical Trials Unit, London School of Hygiene & Tropical MedicineClinical Trials Unit, London School of Hygiene & Tropical MedicineClinical Trials Unit, London School of Hygiene & Tropical MedicineMaternity Unit, Kumba District HospitalHoly Family HospitalDepartment of Obstetrics and Gynaecology, Faculty of Medicine, University of KhartoumDepartment of Obstetrics and Gynaecology, School of Medicine, University of ZambiaSt George’s University of LondonClinical Trials Unit, London School of Hygiene & Tropical MedicineAbstract 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.http://link.springer.com/article/10.1186/s12884-020-03091-8
spellingShingle Roberto Picetti
Lori Miller
Haleema Shakur-Still
Tracey Pepple
Danielle Beaumont
Eni Balogun
Etienne Asonganyi
Rizwana Chaudhri
Mohamed El-Sheikh
Bellington Vwalika
Sabaratnam Arulkumaran
Ian Roberts
on behalf of the WOMAN trial collaborators
The WOMAN trial: clinical and contextual factors surrounding the deaths of 483 women following post-partum haemorrhage in developing countries
BMC Pregnancy and Childbirth
title The WOMAN trial: clinical and contextual factors surrounding the deaths of 483 women following post-partum haemorrhage in developing countries
title_full The WOMAN trial: clinical and contextual factors surrounding the deaths of 483 women following post-partum haemorrhage in developing countries
title_fullStr The WOMAN trial: clinical and contextual factors surrounding the deaths of 483 women following post-partum haemorrhage in developing countries
title_full_unstemmed The WOMAN trial: clinical and contextual factors surrounding the deaths of 483 women following post-partum haemorrhage in developing countries
title_short The WOMAN trial: clinical and contextual factors surrounding the deaths of 483 women following post-partum haemorrhage in developing countries
title_sort woman trial clinical and contextual factors surrounding the deaths of 483 women following post partum haemorrhage in developing countries
url http://link.springer.com/article/10.1186/s12884-020-03091-8
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