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. 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. Background Post-partum haemorrhage (PPH), the leading cause of maternal death worldwide, accounts for about 19.7% of maternal deaths [1, 2]. There are considerable variations across regions with for instance PPH accounting for about 8.0% of maternal deaths in developed countries compared to 19.7% in the developing countries [1]. Maternal outcomes for obstetric haemorrhages, e.g. PPH, are also more severe in developing countries [3]. This disparity between developed and developing areas may be explained by the limited resources in the latter. Some of the deficiencies in the health systems include insufficient availability of properly formed birth attendants both in hospitals and to assist home births, insufficient emergency transport to a facility with better expertise,

Usefulness of Tranexamic Acid in Reducing Blood Loss in Obstetrics And Gynecology, A prospective observational study

“…This multicentric WOMAN trial was carried over 6 years and analyzed on narrative data reporting deaths due to PPH. Collaborators of same trial measuring outcome measures as mortality, hysterectomy, and other morbidities in women with clinical post-partum hemorrhage and use of TXA in a placebo-controlled trial report signi cant difference in TXA and placebo group with a p value of 0.045 [19,20,21]. In our study 66% patients did not need any operative intervention and 33% patients needed operative intervention after treatment with TXA.…”

Why mothers die at a busy tertiary urban hospital in Kampala, Uganda: a comprehensive review of maternal deaths 2016-2018 and implications for quality improvement to reduce deaths

“…This is comparable to data from the national Ugandan maternal mor- The maternal death notification and review at national level were both at 49% which is the same as our study and considerably less than the annual target of (70%) in Health Sector Development Plan (HSDP) plan 27 . Obstetric haemorrhage is a major cause of maternal death globally 28,29 , but several trials have shown promising results for interventions suitable for implementation in low-resource settings to reduce haemorrhage-related deaths. These include uterotonics such as heat-stable carbetocin 30 , although application in this setting may be limited by cost.…”

The cost‐effectiveness of tranexamic acid for treatment of postpartum hemorrhage: A systematic review

“… 25 Notably, the study was an abstract – hence we cannot fully evaluate methods and study quality – and the unit cost of tranexamic acid ($187) was significantly higher than other studies ($5.60 to $50.40) which may have affected the findings. The study used data from WOMAN trial, where most (91.6%) of the study participants were from Africa and Asia 28 with higher rates of maternal mortality and more limited health resources compare to the US context.…”