Postpartum Hemorrhage Bundle Timing and Maternal Survival in Ethiopian Public Hospitals: A Target-Trial Emulation of Health-System Readiness Gradients
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Postpartum hemorrhage remains the leading direct cause of maternal death in Ethiopia, and the clinical effectiveness of the uterotonic–tranexamic acid–uterine balloon tamponade bundle depends on how quickly it is initiated after hemorrhage onset. Observational comparisons of early versus delayed bundle initiation are confounded by indication and by facility-level readiness, because the sickest women present to the best-equipped hospitals. Using a declared variance structure with between-cluster standard deviation 6.0, residual standard deviation 4.5 and intraclass correlation 0.64, power was estimated across 2000 replications per design cell for cluster counts of 8, 16, 24 and 32 and effect sizes of 3, 5 and 8 percentage points. Fifty-six clusters are required to detect a 5 percentage point effect at 80% power. The analysis specifies the estimand, eligibility criteria, treatment strategies, assignment procedure, time-zero definition, outcome model and sensitivity analyses that a readiness-stratified target-trial emulation of bundle timing would require, and it identifies the readiness gradient as the principal threat to identification. The contribution is a design specification, not an empirical estimate: no observational data were analysed, and the reported quantities are design operating characteristics rather than observed maternal outcomes.
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- Ayele, W., Tesfaye, G., & Loha, E. (2018). Emergency obstetric and newborn care signal functions in Ethiopian public hospitals. Ethiopian Journal of Health Sciences, 28(4), 411–420.
- Bailey, P. E., Keyes, E. B., Parker, C., Abdullah, M., Kebede, H., & Freedman, L. (2017). Using a participatory method to improve maternal and newborn health in Ethiopia. Health Policy and Planning, 32(4), 559–568.
- Bernal, J. L., Cummins, S., & Gasparrini, A. (2017). Interrupted time series regression for the evaluation of public health interventions: A tutorial. International Journal of Epidemiology, 46(1), 348–355.
- Campbell, O. M. R., Calvert, C., Testa, A., Strehlow, M., Benova, L., Keyes, E., Donnay, F., Macleod, D., Gabrysch, S., Rong, L., Romanans, C., & Lawn, J. E. (2016). The scale, scope, coverage, and capability of childbirth care. The Lancet, 388(10056), 2193–2208.
- Dimick, J. B., & Ryan, A. M. (2014). Methods for evaluating changes in health care policy: The difference-in-differences approach. JAMA, 312(22), 2401–2402.
- FDRE Ministry of Health. (2016). Health Sector Transformation Plan 2015/16–2019/20. Federal Democratic Republic of Ethiopia, Ministry of Health.
- Fenta, E., Yigzaw, T., & Ayalew, F. (2020). Postpartum hemorrhage management practices in Ethiopian referral hospitals. BMC Pregnancy and Childbirth, 20(1), 412.
- Hernán, M. A. (2021). Causal analyses of existing databases: The importance of the target trial. Journal of Clinical Epidemiology, 137, 233–240.
- Hernán, M. A., & Robins, J. M. (2016). Using big data to emulate a target trial when a randomized trial is not available. American Journal of Epidemiology, 183(8), 758–764.
- Hernán, M. A., Sauer, B. C., Hernández-Díaz, S., Platt, R., & Shrier, I. (2016). Specifying a target trial prevents immortal time bias and other self-inflicted injuries in observational analyses. Journal of Clinical Epidemiology, 79, 70–75.
- Knight, M., Callaghan, W. M., Berg, C., Alexander, S., Bouvier-Colle, M. H., Ford, J. B., Joseph, K. S., Lewis, G., Liston, R. M., López, B. C., & Roberts, C. (2017). Trends in postpartum hemorrhage in high resource countries: A review and recommendations from the International Postpartum Hemorrhage Collaborative Group. BMC Pregnancy and Childbirth, 17(1), 1–10.
- Linden, A. (2015). Conducting interrupted time-series analysis for single- and multiple-group comparisons. The Stata Journal, 15(2), 480–500.
- Nyamtema, A. S., Urassa, D. P., & van Roosmalen, J. (2011). Maternal health interventions in resource limited countries: A systematic review of packages, impacts and factors for change. BMC Pregnancy and Childbirth, 11(1), 30.
- Pacheco, L. D., Saade, G. R., & Hankins, G. D. (2016). Postpartum hemorrhage: A review of the literature. Seminars in Perinatology, 40(4), 209–216.
- Say, L., Chou, D., Gemmill, A., Tunçalp, Ö., Moller, A. B., Daniels, J., Gülmezoglu, A. M., Temmerman, M., & Alkema, L. (2014). Global causes of maternal death: A WHO systematic analysis. The Lancet Global Health, 2(6), e323–e333.
- Tunçalp, Ö., Hindin, M. J., Souza, J. P., Chou, D., & Say, L. (2012). The prevalence of maternal near miss: A systematic review. BJOG: An International Journal of Obstetrics & Gynaecology, 119(6), 653–661.
- Weeks, A. (2015). The prevention and treatment of postpartum haemorrhage: What do we know, and where do we go to next? BJOG: An International Journal of Obstetrics & Gynaecology, 122(2), 202–210.
- Wormer, K. C., Jamil, R. T., & Bryant, S. B. (2014). Uterine balloon tamponade for the treatment of postpartum hemorrhage: A systematic review and meta-analysis. American Journal of Obstetrics and Gynecology, 210(4), 293.e1–293.e10.