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

NCT06854705 | Not Yet Recruiting DMC

• 2 other identifiers: DebreBerhanUINV-075963
• Study Type: interventional
• Target: 1,654
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Midwifery Continuity of Care Model; Maternal Health Outcomes; Neonatal Health Outcomes; Cost Effectiveness

Outcome Measures

Primary Outcomes (2)

• Spontaneous Vaginal Birth

  Proportion of women having a spontaneous vaginal birth.

  12 months

• preterm birth

  The proportion of neonates who had a preterm birth.

  12 months

Study Arms (2)

MiMoC Arm (intervention Group)

EXPERIMENTAL

the MiMoC Arm which will be the intervention group, will provide the continuity of midwifery care (CoMC) starting from antenatal care up to the postnatal period.

Other: Continuity of Midwifery care model

standard care model (control group)

ACTIVE COMPARATOR

Pregnant women who receive antenatal, intrapartum, and postnatal care following standard practice in Ethiopia will be assigned to the control group. An established practice followed the shared model of care in which responsibility is shared among different staff members, including midwives, nurses, health officers, and medical doctors.

Other: Standard care model

Interventions

Continuity of Midwifery care model OTHER

The intervention group will receive a continuity of midwifery care model organized by a team of qualified midwives. In this model, antenatal, intrapartum, and postnatal care will be provided by a named (or primary) midwife, who works within a small team (4-8) of CoMC midwives to their cohort of women and will refer or consult an obstetrician in case of complications that requires specialized care. Each named midwife will be backed up by a partner midwife and other team colleagues. The CoMC team comprises 8 whole-time equivalent midwives, including an experienced senior midwife, who leads the team. Following a training needs assessment by the team leader, midwives will receive specialist training, provided by a team of clinical experts and educators, on how to work in midwife continuity models. Pregnant women receive their entire antenatal, intrapartum, and postnatal care from one of the participating CoMC midwives.

MiMoC Arm (intervention Group)

Standard care model OTHER

Pregnant women who receive antenatal, intrapartum, and postnatal care following standard practice in Ethiopia will be assigned to the control group. An established practice followed the shared model of care in which responsibility is shared among different staff members, including midwives, nurses, health officers, and medical doctors. Midwives and other health care providers worked conventional eight-hour shifts and handed over care to the next health care provider coming on duty during the next shift. In this model of care, each unit of care had its staff working independently. Besides, the health care provider assigned to the postnatal ward will be responsible for immediate postnatal care. After discharge, each woman in this group become the responsibility of a different group of healthcare providers (usually midwives or nurses) in the family planning and immunization room.

standard care model (control group)

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Debre Berhan University: lead
• Dalarna University: collaborator
• Sophiahemmet University: collaborator
• Bill and Melinda Gates Foundation: collaborator

Related Publications (2)

• Hailemeskel S, Alemu K, Christensson K, Tesfahun E, Lindgren H. Midwife-led continuity of care improved maternal and neonatal health outcomes in north Shoa zone, Amhara regional state, Ethiopia: A quasi-experimental study. Women Birth. 2022 Jul;35(4):340-348. doi: 10.1016/j.wombi.2021.08.008. Epub 2021 Sep 3.

  PMID: 34489211 BACKGROUND

• Transitioning to midwifery models of care: global position paper. Geneva: World Health Organization; 2024. Licence: CC BY-NC-SA 3.0 IGO.

  BACKGROUND

Central Study Contacts

Solomon H Beshah, PhD

CONTACT

0913312912; solomonhailemeskel9@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: The intervention group will receive a continuity of midwifery care model organized by a team of qualified midwives. In this model, antenatal, intrapartum, and postnatal care will be provided by a named (or primary) midwife, who works within a small team (4-8) of CoMC midwives to their cohort of women and will refer or consult an obstetrician in case of complications that requires specialized care. Each named midwife will be backed up by a partner midwife and other team colleagues. The CoMC team comprises 8 whole-time equivalent midwives, including an experienced senior midwife, who leads the team.

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 3, 2025
• Study Start: February 24, 2025
• Primary Completion: February 23, 2026
• Study Completion: February 23, 2026
• Last Updated: March 3, 2025

Record last verified: 2025-02