BACKGROUND: Midwifery models of Care (MiMoC) is not standardized in in low-resourced settings, limiting the ability to evaluate the feasibility and effective in improving maternal and neonatal health outcomes compared to a standard care model.

METHODS AND TRIAL: This article describes and discusses rationale, study protocol, and randomisation process for a study that will randomly allocate 1,654 pregnant women to receive or not receive MiMoC in four selected health facilities in Debre Berhan town, Ethiopia. Women will be randomly assigned to either the MiMoC group (Group A) or the standard care model (Group B) using a computer-generated randomisation scheme. In the MiMoC arm (intervention group), women will receive care during pregnancy, labour and birth, and immediate postnatal care from a single midwife or backup midwifes. Conversely, the standard care arm will involve care from various staff members at different times. To evaluate the effect of continuity of midwifery care, the principal maternal health outcome of the study will be the proportion of women having a spontaneous vaginal birth. The primary neonatal health outcome will be the proportion of neonates born preterm. In February 2025, we began recruiting women for the main study. The intervention group will be compared with the control group using an intention-to-treat analysis. Ors and 95% CIs will be estimated. The study was approved by Debre Berhan University's Institutional Review Board and the Swedish National Ethical Review Authority.