The WOMAN Trial: Clinical and Contextual Factors Surrounding the Deaths of 483 Women Following Post-Partum Hemorrhage in Developing Countries

Picetti, Roberto; Miller, Lori K.; Shakur-Still, Haleema; Pepple, Tracey; Balogun, Eni; Asonganyi, Etienne; Chaudhri, Rizwana; El‐Sheikh, Mohamed A.; Vwalika, Bellington; Arulkumaran, Sabaratnam; Roberts, Ian

doi:10.1097/01.ogx.0000723728.09046.e3

Cited by 4 publications

(6 citation statements)

References 7 publications

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“…However, this should be done as part of an overall health system strengthening strategy focused on curbing maternal death and disability. As shown by a secondary analysis of the WOMAN trial, which examined the deaths of 483 women following PPH, other clinical and contextual factors should be tackled, including maternal anemia, delayed referral to higher levels of care, unavailability of blood transfusion, and poor facility infrastructure [ 44 ].…”

Section: Discussionmentioning

confidence: 99%

Tranexamic Acid for Postpartum Hemorrhage Treatment in Low-Resource Settings: A Rapid Scoping Review

Tran

Bar-Zeev

Schulte-Hillen³

et al. 2022

IJERPH

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Tranexamic acid (TXA) effectively reduces bleeding in women with postpartum hemorrhage (PPH) in hospital settings. To guide policies and practices, this rapid scoping review undertaken by two reviewers aimed to examine how TXA is utilized in lower-level maternity care settings in low-resource settings. Articles were searched in EMBASE, MEDLINE, Emcare, the Maternity and Infant Care Database, the Joanna Briggs Institute Evidence-Based Practice Database, and the Cochrane Library from January 2011 to September 2021. We included non-randomized and randomized research looking at the feasibility, acceptability, and health system implications in low- and lower-middle-income countries. Relevant information was retrieved using pre-tested forms. Findings were descriptively synthesized. Out of 129 identified citations, 23 records were eligible for inclusion, including 20 TXA effectiveness studies, two economic evaluations, and one mortality modeling. Except for the latter, all the studies were conducted in lower-middle-income countries and most occurred in tertiary referral hospitals. When compared to placebo or other medications, TXA was found effective in both treating and preventing PPH during vaginal and cesarean delivery. If made available in home and clinic settings, it can reduce PPH-related mortality. TXA could be cost-effective when used with non-surgical interventions to treat refractory PPH. Capacity building of service providers appears to need time-intensive training and supportive monitoring. No studies were exploring TXA acceptability from the standpoint of providers, as well as the implications for health governance and information systems. There is a scarcity of information on how to prepare the health system and services to incorporate TXA in lower-level maternity care facilities in low-resource settings. Implementation research is critically needed to assist practitioners and decision-makers in establishing a TXA-inclusive PPH treatment package to reduce PPH-related death and disability.

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Section: Discussionmentioning

confidence: 99%

Tranexamic Acid for Postpartum Hemorrhage Treatment in Low-Resource Settings: A Rapid Scoping Review

Tran

Bar-Zeev

Schulte-Hillen³

et al. 2022

IJERPH

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“…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.…”

Section: Discussionmentioning

confidence: 99%

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

Aziz

Rossiter

Homer

et al. 2021

Intl J Gynecology & Obste

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Background: Postpartum hemorrhage (PPH) is responsible for nearly one quarter of maternal deaths. A 2017 multicountry trial found that incorporating tranexamic acid (TXA) into the PPH management package was effective in reducing maternal death due to bleeding. Objective: To systematically review studies assessing the cost-effectiveness of tranexamic acid for PPH treatment. Search strategy: Nine databases were searched using variations of keywords 'tranexamic acid', 'postpartum hemorrhage' and 'cost effectiveness'. Selection criteria: Eligible studies were any type of economic or effectiveness evaluation studies on tranexamic acid for treating women with PPH. Data collection and analysis: Two reviewers independently screened citations and extracted data on cost effectiveness measures. Quality was assessed using the Consensus on Health Economic Criteria list.Main results: Four studies were included, of which two were abstracts. Three studies concluded that early administration of TXA was cost-saving or cost-effective. One abstract reported TXA was not cost-effective in the USA unless the probability of death due to hemorrhage is higher. Conclusion:Available evidence (four studies in three countries) suggests that this lifesaving intervention may be below willingness to pay thresholds (cost-effective) or cost saving. Further studies conducted in different populations and settings are needed to inform health policy decision-making to reduce PPH-associated morbidity and mortality.

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“…Through this pro-hemostatic mechanism, TXA reduces bleeding, but it may also increase the risk of thromboembolic events. Recently published randomized clinical trials (RCTs) in trauma and other patient populations have not reported an increased risk of symptomatic thromboembolic events, [4][5][6][7][8] except for one trial in patients with gastrointestinal bleeding. 9 However, some retrospective observational studies have reported an association between TXA use and thromboembolic events in severely injured patients, while others have not.…”

Section: Introductionmentioning

confidence: 99%

“…3 To reduce death from traumatic hemorrhage, tranexamic acid (TXA), an antifibrinolytic agent, is commonly administered in bleeding trauma patients, as large multicenter trials have demonstrated improved primary or secondary outcomes associated with TXA use, including survival. [4][5][6][7][8] TXA is a lysine analog that competitively inhibits the activation of plasminogen to plasmin, and at higher concentrations inhibits plasmin, thus decreasing fibrinolysis and increasing clot stability. Through this pro-hemostatic mechanism, TXA reduces bleeding, but it may also increase the risk of thromboembolic events.…”

Section: Introductionmentioning

confidence: 99%

“…Hyperfibrinolysis following traumatic injury contributes to acute traumatic coagulopathy and is associated with an increased risk of mortality 3 . To reduce death from traumatic hemorrhage, tranexamic acid (TXA), an antifibrinolytic agent, is commonly administered in bleeding trauma patients, as large multicenter trials have demonstrated improved primary or secondary outcomes associated with TXA use, including survival 4–8 …”

Section: Introductionmentioning

confidence: 99%

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The risk of thromboembolic events with early intravenous 2‐ and 4‐g bolus dosing of tranexamic acid compared to placebo in patients with severe traumatic bleeding: A secondary analysis of a randomized, double‐blind, placebo‐controlled, single‐center trial

et al. 2022

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Background Screening for the risk of thromboembolism (TE) due to tranexamic acid (TXA) in patients with severe traumatic injury has not been performed in randomized clinical trials. Our objective was to determine if TXA dose was independently‐associated with thromboembolism. Study Design and Methods This is a secondary analysis of a single‐center, double‐blinded, randomized controlled trial comparing placebo to a 2‐g or 4‐g intravenous TXA bolus dose in trauma patients with severe injury. We used multivariable discrete‐time Cox regression models to identify associations with risk for thromboembolic events within 30 days post‐enrollment. Event curves were created using discrete‐time Cox regression. Results There were 50 patients in the placebo group, 49 in the 2‐g, and 50 in the 4‐g TXA group. In adjusted analyses for thromboembolism, a 2‐g dose of TXA had an hazard ratio (HR, 95% confidence interval [CI]) of 3.20 (1.12–9.11) (p = .029), and a 4‐g dose of TXA had an HR (95% CI) of 5.33 (1.94–14.63) (p = .001). Event curves demonstrated a higher probability of thromboembolism for both doses of TXA compared to placebo. Other parameters independently associated with thromboembolism include time from injury to TXA administration, body mass index, and total blood products transfused. Discussion In patients with severe traumatic injury, there was a dose‐dependent increase in the risk of at least one thromboembolic event with TXA. TXA should not be withheld, but thromboembolism screening should be considered for patients receiving a dose of at least 2‐g TXA intravenously for traumatic hemorrhage.

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The WOMAN Trial: Clinical and Contextual Factors Surrounding the Deaths of 483 Women Following Post-Partum Hemorrhage in Developing Countries

Cited by 4 publications

References 7 publications

Tranexamic Acid for Postpartum Hemorrhage Treatment in Low-Resource Settings: A Rapid Scoping Review

Tranexamic Acid for Postpartum Hemorrhage Treatment in Low-Resource Settings: A Rapid Scoping Review

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

The risk of thromboembolic events with early intravenous 2‐ and 4‐g bolus dosing of tranexamic acid compared to placebo in patients with severe traumatic bleeding: A secondary analysis of a randomized, double‐blind, placebo‐controlled, single‐center trial

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