Remodeling Maternal Health Care: Evaluating the Impact of Implementing the Midwifery Model of Care on Maternal and Neonatal Health Outcomes in Ethiopia (MiMoC Project)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,654
- 主要终点
- Spontaneous Vaginal Birth
研究概览
简要总结
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.
详细描述
Background The World Health Organization (WHO) published a position paper in 2024 stating that Continuity of Midwifery Care (CoMC) models may improve maternal and child health by enabling women to develop relationships with the same caregivers throughout pregnancy, birth, and the postnatal period (1). Women receive care from a named midwife and a backup midwife from the same team, whom they have met before and feel familiar with. This close relationship helps women feel supported by a healthcare provider who knows their medical history and will care for them during labor, birth, and postpartum.
Traditionally, maternity care in Ethiopia has been fragmented, resembling a shared model of care where different healthcare providers assume midwifery roles at various stages. Women may not know their care providers or have previously met the professionals attending their labor. The research team behind this proposal has conducted several studies within the field. A quasi-experimental study among 1,178 low-risk pregnant mothers in four randomly selected primary hospitals in the North Shoa Zone, Amhara Region, demonstrated the successful implementation of a midwife continuity of care model (2). This study highlighted its potential to improve maternal and neonatal health outcomes, increase maternal satisfaction, enhance antenatal and postnatal care utilization, and save lives.
The purpose of this proposal is to increase evidence-based midwife-led practices and strengthen midwives' capacity to lead quality improvement initiatives in maternal and newborn health. The primary goal is to evaluate whether the Midwifery Model of Care (MiMoC), supported by midwife-led birthing centers, is more effective in improving maternal and neonatal health outcomes than the standard care model in Ethiopia. The study will also assess whether this continuous quality improvement initiative increases the uptake of evidence-based practices and enhances midwives' leadership in quality care.
Objectives
- Assess the impact of MiMoC, incorporating midwife-led birthing centers, on maternal health outcomes compared to the standard model of care.
- Evaluate the impact of MiMoC on neonatal health outcomes.
- Explore the experiences and perspectives of healthcare providers, mothers, and companions regarding the continuity of midwifery-led care.
- Measure the effect of MiMoC on the utilization of evidence-based midwife-led practices in health facilities.
- Assess midwives' capacity to lead quality improvement initiatives in a CoMC context.
- Evaluate the cost-effectiveness of MiMoC integrated with midwife-led birthing centers compared to the current maternal healthcare model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All sampled pregnant women above 18 years with gestational age less than 24 whole weeks at the first ANC booking at the Government Hospitals
- •Singleton pregnancy, and
- •low obstetric risk.
排除标准
- •Women who plan to have an elective cesarean section or
- •Women who have a history of medical or obstetric complications.
- •pregnant women who are unable to provide valid information due to mental, hearing, speech, or other medical issues that could worsen their current pregnancy will also be excluded.
- •pregnant mothers who are temporary residents and are expected to leave the study area before the 42-day postpartum period.
- •Women with a history of medical and obstetrics complications.
结局指标
主要结局
Spontaneous Vaginal Birth
时间窗: 12 months
Proportion of women having a spontaneous vaginal birth.
preterm birth
时间窗: 12 months
The proportion of neonates who had a preterm birth.
次要结局
未报告次要终点
研究者
Solomon Hailemeskel Beshah
PhD
Debre Berhan University