Impact of Implementing the Midwifery Model of Care on Maternal and Neonatal Health Outcomes in Ethiopia

Background: The Continuity of Midwifery Care (CoMC) is a maternity care model used in some high-income countries. In this model, a dedicated group of midwives supports women throughout pregnancy, labor, and the early postnatal period. This model has been shown to improve maternal and neonatal outcomes and enhance maternal satisfaction. However, its effectiveness in low-and middle-income countries remains uncertain. Purpose and Aim of the Study: This study aims to evaluate whether CoMC, supported by midwife-led birthing centers, improves maternal and neonatal health outcomes compared to the standard care model in Ethiopia. Research Question: Does the CoMC model, integrated with midwife-led birthing centers, enhance maternal and neonatal outcomes compared to the standard maternal health care model? Additionally, does its implementation strengthen midwives' capacity to deliver quality care and increase the uptake of evidence-based practices in Ethiopia? Methods: A hybrid implementation-effectiveness, randomized, controlled, unblinded, parallel-group pilot trial will be conducted. The type 2 hybrid design will equally emphasize effectiveness and implementation outcomes. The study will take place in four randomly selected hospitals in the North Shoa Zone, Amhara regional state, Ethiopia, involving 1,654 pregnant women (\<20 weeks gestation at first ANC visit). Participants will be randomly assigned to CoMC (Group A) or standard care (Group B) using a computer-generated scheme. Midwives will be organized into teams following the CoMC model. Women will receive study information during ANC visits and, if interested, will discuss participation with the CoMC team leader. Upon consent, they will be randomly allocated using a secure computerized system. In the CoMC arm, women will receive care from a single midwife or a backup midwife throughout pregnancy, labor, birth, and the immediate postnatal period. In the standard care arm, multiple staff members will provide care at different times. Outcomes: The primary maternal outcome is the proportion of women achieving spontaneous vaginal birth. The primary neonatal outcome is the proportion of neonates experiencing preterm birth. These outcomes will be analyzed using bivariable and multivariable generalized linear models (GLMs) with 95% confidence intervals.

NCT Number	NCT06854705
Lead Sponsor	Debre Berhan University Collaborators: Dalarna University, Sophiahemmet University, Bill and Melinda Gates Foundation
Conditions	Midwifery Continuity of Care Model, Maternal Health Outcomes, Neonatal Health Outcomes, Cost Effectiveness
Enrollment	1,654 participants
Start Date	2025-02-24
Primary Completion	2026-02-23 (estimated)
Study Completion	2026-02-23 (estimated)
Updated on ClinicalTrials.gov	2025-03-03