Evaluation of Comprehensive Emergency Obstetric and Neonatal Care Program in Malawi
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- Состояния в реестре: Maternal and Child Health. Базовые параметры: Без ограничений · Все.
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Официальное название
Evaluation of a Program to Improve Comprehensive Emergency Obstetric Care and Maternal Health in Malawi
Обзор
The goal of this observational study is to evaluate the implementation and impact of a comprehensive emergency obstetric and newborn care (CEmONC) program on maternal and perinatal health services and outcomes in Malawi. The study will include health facilities providing delivery care in Lilongwe and Blantyre districts, healthcare providers, and selected clients. The main questions it aims to answer are: 1. Does implementation of the program improve health facility readiness, availability and quality of CEmONC services, and maternal and perinatal death surveillance and response (MPDSR)? 2. Are improvements in facility readiness associated with changes in maternal and perinatal health outcomes over time? Participants and facilities will: * Participate in health facility assessments at baseline, midline, and endline. * Provide routine facility registers and records for retrospective abstraction of pregnancy outcomes, obstetric complications, and maternal and perinatal deaths. * Participate in interviews to describe provider training, clinical practices, and experiences with maternal and newborn care and MPDSR implementation.
Подробное описание
Background and Rationale
Maternal and perinatal mortality remain major public health challenges worldwide despite substantial improvements in access to maternal health services over the past several decades. Although global maternal mortality has declined, the vast majority of maternal and newborn deaths continue to occur in low- and middle-income countries, where health systems frequently face shortages of trained health workers, essential medicines, equipment, and infrastructure necessary to provide high-quality emergency obstetric and newborn care (EmONC). Most maternal deaths result from direct obstetric complications-including postpartum hemorrhage, hypertensive disorders of pregnancy, sepsis, obstructed labor, and complications of abortion-that are largely preventable through timely recognition and appropriate clinical management. Similarly, many stillbirths and neonatal deaths occur because facilities are unable to provide effective intrapartum monitoring, neonatal resuscitation, infection prevention, and specialized newborn care. Strengthening health systems to provide timely, high-quality emergency obstetric and newborn care remains one of the most effective strategies for reducing preventable maternal and newborn deaths.
Increasing the proportion of women who deliver in health facilities has been a central strategy for improving maternal health outcomes. However, evidence from numerous countries demonstrates that increasing facility-based delivery alone is insufficient to substantially reduce maternal and newborn mortality. Women may seek care in facilities that lack reliable electricity or water, trained personnel, blood transfusion capability, operating theaters, essential medicines, or functioning referral systems. Consequently, improvements in access must be accompanied by improvements in the readiness, quality, and functionality of health facilities. Assessments of health facility readiness provide critical information regarding the capacity of facilities to deliver lifesaving obstetric and newborn interventions and help identify health system gaps that require targeted investment and quality improvement efforts.
Malawi has achieved high utilization of maternal health services, with the majority of women delivering in health facilities, yet maternal and neonatal mortality remain substantial public health concerns. The 2024 Malawi Demographic and Health Survey estimated a maternal mortality ratio of 224 maternal deaths per 100,000 live births, representing substantial progress compared with previous estimates but remaining well above international targets. Although facility-based delivery coverage exceeds 90%, important gaps remain across the continuum of maternal and newborn care, including antenatal, intrapartum, and postnatal services. Many health facilities continue to experience shortages of skilled personnel, essential medicines, equipment, infrastructure, and referral capacity necessary to provide comprehensive emergency obstetric and newborn care, limiting the translation of increased service utilization into improved maternal and newborn survival.
Recent national assessments of emergency obstetric and newborn care in Malawi have documented substantial variation in facility readiness and the availability of EmONC signal functions across health facilities. Persistent challenges include shortages of trained healthcare providers, inconsistent availability of essential medicines and supplies, unreliable infrastructure, limited laboratory capacity, and insufficient opportunities for continuing professional development and clinical mentorship. These constraints affect the ability of facilities to rapidly recognize and manage obstetric emergencies and contribute to preventable maternal and perinatal morbidity and mortality. Strengthening facility readiness, provider competency, referral systems, and the quality of obstetric and newborn care therefore remains a national priority.
The Government of Malawi has identified maternal and newborn health as a priority within the Health Sector Strategic Plan III (2023-2030), which emphasizes strengthening health systems, improving the quality and equity of maternal and newborn services, expanding access to Comprehensive Emergency Obstetric and Newborn Care (CEmONC), strengthening referral systems, improving health workforce capacity, and enhancing monitoring and evaluation systems. These priorities align closely with global initiatives to reduce preventable maternal mortality and improve maternal and newborn survival. Generating rigorous evidence regarding implementation of health system strengthening interventions is essential for informing national policy, optimizing resource allocation, and supporting sustainable improvements in maternal and newborn health.
Bloomberg Philanthropies is supporting implementation of a comprehensive maternal and newborn health program in Malawi that seeks to strengthen emergency obstetric and newborn care through improvements in facility readiness, quality of care, provider training, mentorship, supportive supervision, infrastructure, equipment, referral systems, and maternal and perinatal death surveillance and response (MPDSR). The program is implemented by 3 local organizations or partners (CHAI, Seeds Global and Kuhes) in collaboration with the Malawi Ministry of Health and is designed to strengthen health system capacity while improving the quality and accessibility of maternal and newborn health services in Lilongwe and Blantyre districts.
The CDC Foundation, in collaboration with the Malawi Ministry of Health, is conducting an independent longitudinal evaluation of the program. The CDC Foundation is responsible solely for evaluation activities and does not participate in program implementation. This independence allows the evaluation to objectively document changes in facility readiness, service delivery, implementation processes, and maternal and perinatal outcomes over time while providing evidence to inform continuous program improvement.
The evaluation employs a mixed-methods, repeated cross-sectional design conducted at baseline, midline, and endline. Evaluation activities include comprehensive health facility assessments, abstraction of routine pregnancy outcome data from health facility registers, active identification of maternal and perinatal deaths using the Rapid Ascertainment Process of Institutional Deaths (RAPID) methodology, assessment of maternal and perinatal death surveillance and response (MPDSR) systems, and in-depth interviews with healthcare providers and key stakeholders. Together, these complementary data sources will provide a comprehensive assessment of facility readiness, service availability, quality of care, implementation processes, and maternal and perinatal health outcomes throughout the implementation period.
The findings from this evaluation will provide evidence regarding changes in maternal and newborn health services and outcomes during implementation of the program and will be disseminated to the Malawi Ministry of Health, implementing partners, funders, and other stakeholders. Results are intended to support continuous quality improvement, inform policy and resource allocation decisions, strengthen national monitoring and evaluation capacity, and contribute to the global evidence base on large-scale health systems interventions designed to improve maternal and newborn survival in low-resource settings.
Study Design and Setting
This study is a prospective, mixed-methods, repeated cross-sectional evaluation designed to assess the implementation and impact of a comprehensive emergency obstetric and newborn care (CEmONC) program in Malawi. The external evaluation will be conducted over five years and will include three rounds of data collection: a baseline assessment in 2026, a midline assessment in 2028, and an endline assessment in 2030. This repeated assessment design will allow evaluation of changes in health facility readiness, quality of care, implementation processes, and maternal and perinatal health outcomes over the course of program implementation.
The external evaluation is designed to provide independent evidence on changes in health system capacity and maternal and newborn health outcomes associated with implementation of the CEmONC program. The CDC Foundation serves as the independent evaluator and is not involved in implementation of program activities. Findings from the evaluation will be used to inform program improvement, support decision-making by the Malawi Ministry of Health and implementing partners, and contribute to the evidence base on health systems strengthening interventions.
The study will be conducted in Lilongwe and Blantyre districts, two of Malawi's largest and highest-volume districts for maternal and newborn health services. These districts were selected by the Malawi Ministry of Health and program partners based on program priorities and planned implementation activities. All evaluation activities will occur within Malawi.
The study population includes health facilities providing maternity services, healthcare providers involved in maternal and newborn care, maternal and perinatal death surveillance and response (MPDSR) committee members, and women receiving maternity services at selected facilities. Facility-based data will also be collected from routine health records documenting pregnancies, deliveries, obstetric complications, maternal deaths, stillbirths, and neonatal deaths. The evaluation does not involve assignment of participants to interventions; rather, it observes changes associated with implementation of the health system strengthening program.
A census of eligible health facilities within the two districts will be included in the external evaluation. Eligibility criteria include all public, private, faith-based, and mission health facilities providing delivery services and averaging at least 10 deliveries per month. Facilities that do not provide maternity services or conduct fewer than 10 deliveries per month will be excluded. Based on current planning, 78 facilities are expected to participate, including hospitals, community hospitals, health centers, and other eligible delivery facilities.
The evaluation employs a mixed-methods approach that integrates multiple complementary data sources to provide a comprehensive assessment of maternal and newborn health services and outcomes. Quantitative data collection includes: (1) Health Facility Assessments (HFA) to evaluate facility infrastructure, staffing, equipment, supplies, service availability, referral capacity, and implementation of emergency obstetric and newborn care; (2) the Pregnancy Outcome Monitoring System (POMS), which abstracts individual-level pregnancy outcomes and obstetric complications from routine facility registers; and (3) the Rapid Ascertainment Process of Institutional Deaths (RAPID), which enhances identification of maternal and perinatal deaths through systematic review and triangulation of multiple facility data sources. Qualitative data collection includes in-depth interviews with healthcare providers and key stakeholders involved in maternal and newborn care and MPDSR implementation to better understand implementation experiences, barriers, facilitators, and opportunities for program improvement.
Health facility assessments will be conducted at each of the three evaluation time points using standardized data collection instruments. In addition, retrospective pregnancy outcome data will be abstracted from routine facility registers covering the period immediately preceding each assessment. The baseline assessment will abstract approximately 18 months of retrospective data collected before program implementation. The midline assessment will abstract data covering the subsequent implementation period, and the endline assessment will abstract the final 24 months of program implementation. This approach
Первичные конечные точки
- Availability of emergency obstetric and newborn care (EmONC) [Срок оценки: From baseline through study completion, an average of 3 years and 8 months]
- Institutional delivery rate [Срок оценки: From baseline through study completion, an average of 3 years and 8 months]
- Proportion of all births in EmONC facilities [Срок оценки: From baseline through study completion, an average of 3 years and 8 months]
- Institutional C-section rate [Срок оценки: From baseline through study completion, an average of 3 years and 8 months]
- Population-based C-section rate [Срок оценки: From baseline through study completion, an average of 3 years and 8 months]
- Direct obstetric case fatality rate [Срок оценки: From baseline through study completion, an average of 3 years and 8 months]
- Institutional maternal mortality ratio [Срок оценки: From baseline through study completion, an average of 3 years and 8 months]
- Institutional maternal mortality ratio due to postpartum hemorrhage (PPH) [Срок оценки: From baseline through study completion, an average of 3 years and 8 months]
- Postpartum hemorrhage (PPH)-specific case fatality rate [Срок оценки: From baseline through study completion, an average of 3 years and 8 months]
- Institutional intrapartum stillbirth rate [Срок оценки: From baseline through study completion, an average of 3 years and 8 months]
Критерии участия
Критерии включения
\- Health facilities that report an average of at least 120 deliveries per year
Критерии исключения
- Health facilities that do not provide maternity care
- Health facilities that do not report an average of at least 120 deliveries per year
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
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Центры проведения
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Идентификаторы
NCT: NCT07727928 · 10100407_5