Midwifery Continuity of Care ModelMiMoCNCT06854705
Impact of Implementing the Midwifery Model of Care on Maternal and Neonatal Health Outcomes in Ethiopia
A study testing Continuity of Midwifery care model in people with Midwifery Continuity of Care Model and Maternal Health Outcomes, run by Debre Berhan University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Midwifery Continuity of Care Model, Maternal Health Outcomes, Neonatal Health Outcomes
- What is being tested?
- Continuity of Midwifery care model
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,654 participants
- Where
- No sites listed yet
- Study dates
- 24 Feb 2025to 23 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Remodeling Maternal Health Care: Evaluating the Impact of Implementing the Midwifery Model of Care on Maternal and Neonatal Health Outcomes in Ethiopia (MiMoC Project)
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.
Read more
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.
Read the detailed description
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.
Methods Between February 24, 2025, and February 23, 2026, 1,654 pregnant women in Debre Berhan with gestational ages of less than 24 weeks will be randomly allocated to receive either the MiMoC intervention or standard care. Randomization will occur at selected health facilities using a secure computerized system (MedSciNet). Effect-modifying and confounding factors will be considered in the analysis. Primary and secondary endpoints will be analyzed according to the intention-to-treat principle. Ethical approval has been obtained from the Swedish Ethical Review Board and the study is registered with ClinicalTrials.gov.
Study Design A hybrid implementation-effectiveness randomized controlled, unblinded, parallel-group pilot trial design will be used. A type 2 hybrid design will allow for equal focus on intervention effectiveness and implementation. A quality improvement approach will guide intervention implementation, and results will be reported following Consolidated Standards of Reporting Trials (CONSORT) guidelines.
Sample Size Estimation Sample size was determined using STATA software, based on prior research comparing maternal and neonatal outcomes in CoMC versus standard care in North Shoa Zone. The largest required sample size was based on the proportion of perineal tears (1.2% in CoMC vs. 3.6% in standard care), with a 95% confidence level and 80% power. Assuming a 15% loss to follow-up, 1,654 participants (827 per group) are required.
Randomization Process Eligible pregnant women receiving antenatal care at selected health facilities will be informed about the study and referred to the MiMoC team leader if interested. After providing written informed consent, participants will be randomized 1:1 into either the MiMoC or standard care group using a secure computerized system.
Implementation MiMoC, supported by midwife-led birthing centers, will be coordinated by Debre Berhan University Hakim Gizaw Teaching Hospital in collaboration with midwifery, obstetrics, gynecology, and pediatric departments. Investigators from Debre Berhan University and Sophiahemmet University (Sweden) will provide training on organizing and implementing MiMoC. Additional training for facility staff will be documented and evaluated. Biweekly digital meetings will support champions leading MiMoC implementation, using run charts to monitor key performance indicators.
Fidelity of Intervention Delivery Treatment fidelity will be monitored throughout training and intervention delivery. Midwives in the intervention group will be trained to adhere to clinical guidelines and maintain continuity of care. Fidelity will be assessed through midwife interviews, research team meetings, and medical record reviews. Measures include antenatal care completion, care continuity, referrals, and women's perceptions of provider continuity.
Outcome Variables
Maternal:
- Mode of birth, episiotomy, perineal trauma, labor augmentation, hemorrhage, prolonged/obstructed labor, maternal death (within 42 days), satisfaction with care, and healthcare utilization.
Neonatal:
- Birth status, perinatal death, APGAR scores, birth complications, birth weight, NICU admission, and early breastfeeding initiation.
Cost:
- Healthcare provider costs, including salaries, goods and services, and repair/maintenance costs, will be analyzed for cost-effectiveness.
Feasibility:
- Recruitment, attrition rates, fidelity (proportion of births attended by a known midwife), and clinical decision-making processes will be assessed.
Data Collection Independent data collection teams will be established in each hospital. Research assistants will ensure quality control in data collection and transfer to the central research center (Debre Berhan University and Sweden). Clinical data will be anonymized, with unique identification numbers assigned. Data collection will focus on maternal and neonatal health outcomes, adherence to MiMoC, and midwives' leadership in quality improvement.
Data Analysis
Intention-to-treat analysis will be used. Binary correlated data will be analyzed using McNemar's test, and differences between health facilities will be assessed using logistic regression. Training scores will be analyzed longitudinally using mixed model effects. Cost-effectiveness analysis will compare incremental costs and health outcomes, using the Incremental Cost-Effectiveness Ratio (ICER):
ICER = (Cost of MiMoC - Cost of Standard Care) / (Effect of MiMoC - Effect of Standard Care) Costs per patient will be estimated based on real-life healthcare use over pregnancy, labor, and the postnatal period.
Dissemination and Impact This research will generate evidence-based recommendations for scaling up MiMoC, supported by midwife-led birthing centers, to improve maternal and neonatal health outcomes in Ethiopia. The project aligns with Sustainable Development Goals 3 and 5, aiming to empower women and reduce maternal and neonatal mortality. Results will be disseminated to policymakers, healthcare providers, and communities through national and international conferences and peer-reviewed publications. If effective, MiMoC will be scaled to other regions and low- and middle-income countries. Policy briefs and implementation guidelines will be developed, and midwifery birthing centers will be established.
Ethical Considerations Ethical approval has been obtained from Debre Berhan University's Institutional Review Board and the Swedish National Ethical Review Board. The study will adhere to ethical research standards, including informed consent, data protection, inclusivity, and participant well-being.
- Conditions
- Midwifery Continuity of Care Model, Maternal Health Outcomes, Neonatal Health Outcomes, Cost Effectiveness
- Being tested
- Continuity of Midwifery care model, Standard care model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuity of Midwifery care modelOther
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.
Standard care modelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard care model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous Vaginal Birth
Proportion of women having a spontaneous vaginal birth.
Measured: 12 months
preterm birth
The proportion of neonates who had a preterm birth.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start24 Feb 2025 (estimated)
- Primary completion23 Feb 2026 (estimated)
- Study completion23 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Midwifery Continuity of Care ModelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,654 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Debre Berhan University
- Sponsor type
- University, hospital or other
- Collaborators
- Dalarna University, Sophiahemmet University, Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Solomon Hailemeskel Beshah, Debre Berhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854705
- Sponsor's protocol ID
- DebreBerhanU
- Other IDs
- INV-075963
- Acronym
- MiMoC
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34489211Transitioning to midwifery models of care: global position paper. Geneva: World Health Organization; 2024. Licence: CC BY-NC-SA 3.0 IGO.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remodeling Maternal Health Care: Evaluating the Impact of Implementing the Midwifery Model of Care on Maternal and Neonatal Health Outcomes in Ethiopia (MiMoC Project)
- ClinicalTrials.gov ID
- NCT06854705
- Acronym / sponsor ID
- MiMoC / DebreBerhanU
- Conditions
- Midwifery Continuity of Care Model, Maternal Health Outcomes, Neonatal Health Outcomes, Cost Effectiveness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,654 participants (estimated)
- Lead sponsor
- Debre Berhan UniversityUniversity, hospital or other
- Collaborators
- Dalarna University, Sophiahemmet University, Bill and Melinda Gates Foundation
- Study start
- 24 Feb 2025 (estimated)
- Primary completion
- 23 Feb 2026 (estimated)
- Study completion
- 23 Feb 2026 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Methods Between February 24, 2025, and February 23, 2026, 1,654 pregnant women in Debre Berhan with gestational ages of less than 24 weeks will be randomly allocated to receive either the MiMoC intervention or standard care. Randomization will occur at selected health facilities using a secure computerized system (MedSciNet). Effect-modifying and confounding factors will be considered in the analysis. Primary and secondary endpoints will be analyzed according to the intention-to-treat principle. Ethical approval has been obtained from the Swedish Ethical Review Board and the study is registered with ClinicalTrials.gov.
Study Design A hybrid implementation-effectiveness randomized controlled, unblinded, parallel-group pilot trial design will be used. A type 2 hybrid design will allow for equal focus on intervention effectiveness and implementation. A quality improvement approach will guide intervention implementation, and results will be reported following Consolidated Standards of Reporting Trials (CONSORT) guidelines.
Sample Size Estimation Sample size was determined using STATA software, based on prior research comparing maternal and neonatal outcomes in CoMC versus standard care in North Shoa Zone. The largest required sample size was based on the proportion of perineal tears (1.2% in CoMC vs. 3.6% in standard care), with a 95% confidence level and 80% power. Assuming a 15% loss to follow-up, 1,654 participants (827 per group) are required.
Randomization Process Eligible pregnant women receiving antenatal care at selected health facilities will be informed about the study and referred to the MiMoC team leader if interested. After providing written informed consent, participants will be randomized 1:1 into either the MiMoC or standard care group using a secure computerized system.
Implementation MiMoC, supported by midwife-led birthing centers, will be coordinated by Debre Berhan University Hakim Gizaw Teaching Hospital in collaboration with midwifery, obstetrics, gynecology, and pediatric departments. Investigators from Debre Berhan University and Sophiahemmet University (Sweden) will provide training on organizing and implementing MiMoC. Additional training for facility staff will be documented and evaluated. Biweekly digital meetings will support champions leading MiMoC implementation, using run charts to monitor key performance indicators.
Fidelity of Intervention Delivery Treatment fidelity will be monitored throughout training and intervention delivery. Midwives in the intervention group will be trained to adhere to clinical guidelines and maintain continuity of care. Fidelity will be assessed through midwife interviews, research team meetings, and medical record reviews. Measures include antenatal care completion, care continuity, referrals, and women's perceptions of provider continuity.
Outcome Variables
Maternal:
- Mode of birth, episiotomy, perineal trauma, labor augmentation, hemorrhage, prolonged/obstructed labor, maternal death (within 42 days), satisfaction with care, and healthcare utilization.
Neonatal:
- Birth status, perinatal death, APGAR scores, birth complications, birth weight, NICU admission, and early breastfeeding initiation.
Cost:
- Healthcare provider costs, including salaries, goods and services, and repair/maintenance costs, will be analyzed for cost-effectiveness.
Feasibility:
- Recruitment, attrition rates, fidelity (proportion of births attended by a known midwife), and clinical decision-making processes will be assessed.
Data Collection Independent data collection teams will be established in each hospital. Research assistants will ensure quality control in data collection and transfer to the central research center (Debre Berhan University and Sweden). Clinical data will be anonymized, with unique identification numbers assigned. Data collection will focus on maternal and neonatal health outcomes, adherence to MiMoC, and midwives' leadership in quality improvement.
Data Analysis
Intention-to-treat analysis will be used. Binary correlated data will be analyzed using McNemar's test, and differences between health facilities will be assessed using logistic regression. Training scores will be analyzed longitudinally using mixed model effects. Cost-effectiveness analysis will compare incremental costs and health outcomes, using the Incremental Cost-Effectiveness Ratio (ICER):
ICER = (Cost of MiMoC - Cost of Standard Care) / (Effect of MiMoC - Effect of Standard Care) Costs per patient will be estimated based on real-life healthcare use over pregnancy, labor, and the postnatal period.
Dissemination and Impact This research will generate evidence-based recommendations for scaling up MiMoC, supported by midwife-led birthing centers, to improve maternal and neonatal health outcomes in Ethiopia. The project aligns with Sustainable Development Goals 3 and 5, aiming to empower women and reduce maternal and neonatal mortality. Results will be disseminated to policymakers, healthcare providers, and communities through national and international conferences and peer-reviewed publications. If effective, MiMoC will be scaled to other regions and low- and middle-income countries. Policy briefs and implementation guidelines will be developed, and midwifery birthing centers will be established.
Ethical Considerations Ethical approval has been obtained from Debre Berhan University's Institutional Review Board and the Swedish National Ethical Review Board. The study will adhere to ethical research standards, including informed consent, data protection, inclusivity, and participant well-being.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| MiMoC Arm (intervention Group) | Experimental | Other: Continuity of Midwifery care modelthe 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. |
| standard care model (control group) | Active comparator | Other: Standard care modelPregnant 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuity of Midwifery care modelThe 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. | Other | MiMoC Arm (intervention Group) |
| Standard care modelPregnant 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. | Other | standard care model (control group) |
Primary outcome
Spontaneous Vaginal Birth
Time frame: 12 months
Proportion of women having a spontaneous vaginal birth.
preterm birth
Time frame: 12 months
The proportion of neonates who had a preterm birth.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Background: PubMed 34489211Hailemeskel 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.
- BackgroundTransitioning to midwifery models of care: global position paper. Geneva: World Health Organization; 2024. Licence: CC BY-NC-SA 3.0 IGO.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Continuity of Midwifery care model in people with Midwifery Continuity of Care Model and Maternal Health Outcomes, run by Debre Berhan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Solomon H Beshah, PhD (0913312912 ext. +251, solomonhailemeskel9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous Vaginal Birth (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06854705, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.