Background
Postpartum haemorrhage (PPH) remains a leading cause of maternal morbidity and mortality worldwide, notably in low-resource settings. Traditionally, primary PPH is defined as blood loss of 500 mL or more within 24 hours following vaginal delivery. However, this definition may inadequately emphasize the critical early postpartum period when most bleeding complications are diagnosed and managed. Limited data exist regarding the precise timing of PPH diagnosis and the diagnostic criteria utilized in routine clinical practice, impeding optimized intervention strategies. The E-MOTIVE trial, a cluster-randomised study, introduced an early diagnosis protocol paired with a bundled treatment approach, demonstrating a substantial 60% relative reduction in adverse maternal outcomes related to bleeding compared with standard care. This nested observational study aimed to delineate the timing of PPH diagnosis and explore diagnostic methodologies across four African countries implementing the E-MOTIVE intervention.
Study Design
This observational study was nested within the larger E-MOTIVE cluster-randomised trial (NCT04341662). Conducted between June 27 and December 18, 2022, the study included 39 hospitals in Nigeria, Kenya, Tanzania, and South Africa, where the E-MOTIVE intervention was actively implemented. Continuous direct clinical observations lasting one to two weeks were performed by trained observers, starting from vaginal birth up to two hours postpartum. Healthcare workers were educated to diagnose PPH based on clinical judgment—such as heavy vaginal blood loss, passage of large clots, or persistent trickling—and on objective criteria involving blood loss volume thresholds and clinical signs. In Nigeria, Kenya, and Tanzania, PPH diagnosis required either blood loss of 300 mL or more with at least one abnormal clinical sign (pulse, blood pressure, uterine tone, or vaginal bleeding) or 500 mL or more regardless of signs. South Africa primarily used the conventional 500 mL blood loss threshold alone. Data collected included the timing from vaginal birth to PPH diagnosis and the diagnostic criteria employed.
Key Findings
Among 2578 observed vaginal births, 295 instances of PPH were diagnosed. The median time from birth to PPH diagnosis varied significantly by country: 15 minutes in Nigeria and Tanzania, 17 minutes in Kenya, and 30 minutes in South Africa. When examining the proportion of PPH diagnoses within 30 minutes of delivery, values ranged from 58% in South Africa to 86% in Tanzania. Diagnostic rates reached 96% to 100% by 60 minutes postpartum across all sites, with all PPH cases necessitating intervention recognized within 90 minutes.
Diagnostic approaches differed notably by country. Nigeria, Kenya, and Tanzania predominantly applied a threshold of 300 mL blood loss combined with abnormal clinical signs in 47%, 65%, and 68% of cases, respectively. In contrast, South Africa relied on a blood loss volume of 500 mL or more in 81% of diagnoses. These methodological differences correlated with earlier recognition and intervention in countries employing the lower combined threshold, suggesting a more sensitive diagnostic strategy accelerates clinical response.
Interpretation and Expert Commentary
The findings underscore the critical impact of diagnostic criteria on the timing of PPH recognition and management. Utilizing a lower objective blood loss threshold of 300 mL supplemented by clinical warning signs can facilitate earlier identification of hemorrhagic risk than the traditional 500 mL criterion alone. Early diagnosis is clinically significant because it enables prompt interventions that can prevent progression to severe morbidity or mortality, especially in resource-limited environments. The near-universal diagnosis of PPH within 90 minutes across sites attests to the effectiveness of rigorous clinical observation and the E-MOTIVE intervention in enhancing surveillance.
The diagnostic approach combining quantitative and qualitative indicators aligns with current calls to refine PPH definitions to better capture early bleeding and physiological compromise. However, reliance on clinical signs requires adequate training and standardization, as subjective assessment may vary. Furthermore, the study’s observational design nested within a trial intervention may limit generalizability beyond the hospital contexts studied. Nonetheless, these findings support modification of PPH diagnostic protocols to integrate earlier, multifactorial criteria to expedite care.
Conclusion
This nested observational study within the E-MOTIVE trial demonstrates that prioritizing a 300 mL blood loss threshold combined with abnormal clinical signs results in significantly earlier PPH diagnosis compared to the conventional 500 mL volume criterion. Early recognition facilitates timely interventions, which are crucial to reducing adverse maternal outcomes from postpartum bleeding. Adoption of this diagnostic strategy could enhance maternal care, particularly in low-resource settings where the burden of PPH is greatest. Future research should focus on standardizing and validating objective and clinical signs to optimize early PPH detection and guide resource-appropriate therapeutic pathways.
Funding and Trial Registration
This research was funded by the Bill & Melinda Gates Foundation and Ammalife. The parent E-MOTIVE trial is registered under ClinicalTrials.gov identifier NCT04341662.
References
Mammoliti KM, Martin J, Devall A, Easter C, Althabe F, Funmi AL, Yusuf R, Abubakar F, Arigbede LC, Mugambi JK, Oyoo P, Sambusa M, Banda A, Samuels F, Willemse S, Khambule SD, Shu’aib HM, Wakili AA, Okore J, Mwampashi A, Singata-Madliki M, Arends E, Muller E, Galadanci H, Qureshi Z, Al-Beity FA, Hofmeyr GJ, Fawcus S, Moran N, Osoti A, Gwako G, Gallos I, Coomarasamy A. When are postpartum haemorrhages diagnosed? A nested observational study within the E-MOTIVE cluster-randomised trial. Lancet Glob Health. 2025 Nov;13(11):e1946-e1954. doi:10.1016/S2214-109X(25)00302-X. PMID: 41109265; PMCID: PMC12535819.
