Early assessment of maternal bleeding: development and validation of a prognostic model predicting death and near miss - Ageron, F. X.; Ker, K.; Prowse, D.; Steyerberg, E. W.; Balogun, E.; Shakur-Still, H.; Bello, F. A.; Madar, H.; Deneux-Tharaux, C.; Chaudhri, R.; Olayemi, O.; Muganyizi, P.; et al. (Lancet Glob Health, 2026)
BACKGROUND: Bleeding after childbirth is a leading cause of mortality. Most deaths are in low-income and middle-income countries. Early identification of women at high risk of life-threatening bleeding is vital to guide the use of life-saving interventions. The aim of this study was to develop and validate a prognostic model to predict death and near miss from bleeding after childbirth and to use it to a create simple clinical score to identify women's level of risk at admission. METHODS: This observational prognostic study used multilevel logistic regression with data from 22 low-income, middle-income, and high-income countries. We used individual patient data from four randomised controlled trials (WOMAN, WOMAN-2, TRAAP, and TRAAP2 trials) that assessed the effect of tranexamic acid administration on maternal death and blood loss after birth, vaginally or by caesarean. The predicted outcome was death or near miss based on the WHO near miss approach to life-threatening postpartum bleeding. Maternal death included all deaths within 24 h of birth. Near miss included laparotomy, hysterectomy, or interventional radiology within 24 h of birth. The model included a random effect for country and trial and underwent internal-external cross-validation. A simple score for clinical use was developed from the coefficient of the regression equation, and the clinical value of the prognostic model and score was assessed by decision curve analysis. FINDINGS: We included data on 43 450 women enrolled in the four trials. Death or near miss occurred in 1291 women (3.0%). The model predicting death or near miss included age, baseline systolic blood pressure, pre-birth anaemia, caesarean birth, placental disorders, hypertensive disease during pregnancy, and whether the birth being studied was a stillbirth. By use of internal-external cross-validation, the pooled area under the receiving operator curve (AUROC) for the model was 0.82 (95% CI 0.78-0.87). Our simple clinical score to identify women at very low (risk unlikely), low, intermediate, high, or very high risk of death or near miss had an AUROC of 0.80 (0.76-0.84). Discrimination was heterogeneous between countries, with low AUROC (0.58 [0.48-0.68]) in the only high-income country included in the cross-validation (France). The model and the score presented a clinical value with a positive net benefit for a wide range of risk of death or near miss. INTERPRETATION: We developed a prognostic model and a simple score that can be used at hospital admission to quantify the risk of life-threatening bleeding in women giving birth. This score can be used to inform the need for early tranexamic acid administration in women giving birth in low-income and middle-income countries. FUNDING: The Gates Foundation.
Keywords: journalArticle; *Near Miss, Healthcare/statistics & numerical data; *Postpartum Hemorrhage/mortality/diagnosis; Adult; Female; Foundation, the Wellcome Trust, the Jon Moulton Charitable Foundation, the; Health and Care Excellence guidance. LS reports receipt of payment or honoraria; Humans; Joint Royal Colleges tranexamic acid in surgery implementation group) to increase; Logistic Models; Maternal Death; Maternal Mortality; Medicine). IR also declares an unpaid role as convenor of an ad-hoc group (The; National Institute for Health and Care Research, Unitaid, and Open Philanthropy; Organon for lectures, presentations, speakers bureaus, manuscript writing, or; Pregnancy; Prognosis; Risk Assessment; Tranexamic Acid/therapeutic use; educational events. All other authors declare no competing interests; for research on the role of tranexamic acid (an inexpensive generic drug) in; from Ferring Pharmaceuticals, Norgine, Bayer, Pfizer, GlaxoSmithKline, and; the use of tranexamic acid in surgical patients as per National Institute for; treatment of life-threatening bleeding and on anaemia treatment. All payments; were made to their employing institution (London School of Hygiene & Tropical