Evaluation of a Program to Improve Comprehensive Emergency Obstetric Care and Maternal Health in Malawi
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 主要终点
- Availability of EmONC
研究概览
简要总结
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:
- Does implementation of the program improve health facility readiness, availability and quality of CEmONC services, and maternal and perinatal death surveillance and response (MPDSR)?
- 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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Health facilities that report an average of at least 120 deliveries per year
排除标准
- •Health facilities that do not provide maternity care
- •Health facilities that do not report an average of at least 120 deliveries per year
研究组 & 干预措施
Health facilities
78 health facilities
结局指标
主要结局
Availability of EmONC
时间窗: From baseline through study completion, an average of 5 years
The number of facilities providing EmONC per 500,000 total population
Institutional delivery rate
时间窗: From baseline through study completion, an average of 5 years
The number of women who delivered in health facilities divided by the expected number of live births in the area of observation
Proportion of all births in EmONC facilities
时间窗: From baseline through study completion, an average of 5 years
The number of women who delivered in EmONC facilities divided by the expected number of live births in the area of observation
Institutional C-section rate
时间窗: From baseline through study completion, an average of 5 years
Number of women who delivered by c-section/number of women who gave birth in health facilities \*100 per yr
Population-based C-section rate
时间窗: From baseline through study completion, an average of 5 years
Number of women who delivered by c-section/estimated number of women who gave birth within a year\*100 per yr
Direct obstetric case fatality rate
时间窗: From baseline through study completion, an average of 5 years
Number of women who died from major direct obstetric complications in health facilities/ total number of women treated for direct obstetric complications in health facilities\*100 per yr
Institutional maternal mortality ratio
时间窗: From baseline through study completion, an average of 5 years
Number of institutional maternal deaths/number of institutional live births\*100,000 per yr
Institutional maternal mortality ratio due to PPH
时间窗: From baseline through study completion, an average of 5 years
Number of institutional maternal deaths due to PPH/number of institutional live births\*100,000 per yr
PPH-specific case fatality rate
时间窗: From baseline through study completion, an average of 5 years
Number of women who died from PPH in health facilities/number of women experiencing PPH in health facilities\*100 per yr
Institutional intrapartum stillbirth rate
时间窗: From baseline through study completion, an average of 5 years
Number of institutional intrapartum stillbirths/number of institutional births (live births + stillbirths) \*1000 per yr
Institutional perinatal mortality rate
时间窗: From baseline through study completion, an average of 5 years
Number of institutional intrapartum and early neonatal deaths/number of institutional births (live births + stillbirths) \*1000 per yr
Institutional neonatal mortality rate
时间窗: From baseline through study completion, an average of 5 years
Number of institutional neonatal deaths 0-28 days/number of institutional live births\*1000
Birth-weight specific institutional neonatal mortality rates
时间窗: From baseline through study completion, an average of 5 years
Number of deaths to newborns with birthweight of \<1000 g, 1000-1499, 1500-2499, and 2500+ /number of newborns in corresponding birth category\*1000
Met need for obstetric care
时间窗: From baseline through study completion, an average of 5 years
Number of women with direct obstetric complications who delivered in health facilities/estimated number of women with obstetric complications who gave birth within a year\*100 per yr
Percentage of vaginal or assisted deliveries in which calibrated drapes were used
时间窗: From baseline through study completion, an average of 5 years
Number of women who had vaginal delivery (SVD and assisted) and used the calibrated drapes / Total number of women who had vaginal or assisted delivery
Percentage of women who received prophylactic uterotonic (oxytocin, ergometrine, or misoprostol) during the third stage of labor
时间窗: From baseline through study completion, an average of 5 years
Number of women who received prophylactic uterotonic (oxytocin, carbetocin, or misoprostol) during the third stage /number of women who delivered in the health facility
Percentage of PPH cases in which TXA was administered for treatment of PPH
时间窗: From baseline through study completion, an average of 5 years
Number of PPH cases in which TXA was administered for treatment of PPH/total number of PPH cases with blood loss\>500ml following vaginal or assisted delivery or \>1000ml following c-section delivery
Percentage of women with companionship at birth (3 months)
时间窗: From baseline through study completion, an average of 5 years
Number of women who delivered in health facilities and were accompanied by their partners or other companions at birth/number of women who delivered in health facilities \*100
Progress toward interim goal for scaling up EmONC availability
时间窗: From baseline through study completion, an average of 5 years
Number of facilities performing all EmONC signal functions/number of designated EmONC facilities\*100
Equipment, drugs & supplies
时间窗: From baseline through study completion, an average of 5 years
Number of facilities with all tracer commodities/total number of facilities\*100
Emergency referral readiness
时间窗: From baseline through study completion, an average of 5 years
Number of facilities meeting the criteria for essential emergency referral readiness/total number of facilities assessed\*100
Home to Comprehensive EmONC within 1 hour
时间窗: From baseline through study completion, an average of 5 years
Number of people in a specified area able to access at least a Comprehensive EmONC facility within 1 hour travel time/total population in a specified area\*100
Health workforce adequate for caseload
时间窗: From baseline through study completion, an average of 5 years
Number of facilities meeting caseload-specific staffing recommendations per shift/total number of facilities\*100
Facility MPDSR implementation readiness
时间窗: From baseline through study completion, an average of 5 years
Implementation readiness score based on the presence of key organizational attributes required to establish, integrate, and sustain maternal and perinatal death surveillance and response processes
Availability of emergency obstetric and newborn care (EmONC)
时间窗: From baseline through study completion, an average of 3 years and 8 months
The number of facilities providing emergency obstetric and newborn care (EmONC) per 500,000 total population
Institutional delivery rate
时间窗: From baseline through study completion, an average of 3 years and 8 months
The number of women who delivered in health facilities divided by the expected number of live births in the area of observation
Proportion of all births in EmONC facilities
时间窗: From baseline through study completion, an average of 3 years and 8 months
The number of women who delivered in EmONC facilities divided by the expected number of live births in the area of observation
Institutional C-section rate
时间窗: From baseline through study completion, an average of 3 years and 8 months
Number of women who delivered by c-section/number of women who gave birth in health facilities \*100 per yr
Population-based C-section rate
时间窗: From baseline through study completion, an average of 3 years and 8 months
Number of women who delivered by c-section/estimated number of women who gave birth within a year\*100 per yr
Direct obstetric case fatality rate
时间窗: From baseline through study completion, an average of 3 years and 8 months
Number of women who died from major direct obstetric complications in health facilities/ total number of women treated for direct obstetric complications in health facilities\*100 per yr
Institutional maternal mortality ratio
时间窗: From baseline through study completion, an average of 3 years and 8 months
Number of institutional maternal deaths/number of institutional live births\*100,000 per yr
Institutional maternal mortality ratio due to postpartum hemorrhage (PPH)
时间窗: From baseline through study completion, an average of 3 years and 8 months
Number of institutional maternal deaths due to postpartum hemorrhage (PPH) /number of institutional live births\*100,000 per yr
Postpartum hemorrhage (PPH)-specific case fatality rate
时间窗: From baseline through study completion, an average of 3 years and 8 months
Number of women who died from postpartum hemorrhage (PPH) in health facilities/number of women experiencing PPH in health facilities\*100 per yr
Institutional intrapartum stillbirth rate
时间窗: From baseline through study completion, an average of 3 years and 8 months
Number of institutional intrapartum stillbirths/number of institutional births (live births + stillbirths) \*1000 per yr
Institutional perinatal mortality rate
时间窗: From baseline through study completion, an average of 3 years and 8 months
Number of institutional intrapartum and early neonatal deaths/number of institutional births (live births + stillbirths) \*1000 per yr
Institutional neonatal mortality rate
时间窗: From baseline through study completion, an average of 3 years and 8 months
Number of institutional neonatal deaths 0-28 days/number of institutional live births\*1000
Birth-weight specific institutional neonatal mortality rates
时间窗: From baseline through study completion, an average of 3 years and 8 months
Number of deaths to newborns with birthweight of \<1000 g, 1000-1499, 1500-2499, and 2500+ /number of newborns in corresponding birth category\*1000
Met need for obstetric care
时间窗: From baseline through study completion, an average of 3 years and 8 months
Number of women with direct obstetric complications who delivered in health facilities/estimated number of women with obstetric complications who gave birth within a year\*100 per yr
Percentage of vaginal or assisted deliveries in which calibrated drapes were used
时间窗: From baseline through study completion, an average of 3 years and 8 months
Number of women who had vaginal delivery (SVD and assisted) and used the calibrated drapes / Total number of women who had vaginal or assisted delivery
Percentage of women who received prophylactic uterotonic (oxytocin, ergometrine, or misoprostol) during the third stage of labor
时间窗: From baseline through study completion, an average of 3 years and 8 months
Number of women who received prophylactic uterotonic (oxytocin, carbetocin, or misoprostol) during the third stage /number of women who delivered in the health facility
Percentage of postpartum hemorrhage (PPH) cases in which tranexamic acid (TXA) was administered for treatment of PPH
时间窗: From baseline through study completion, an average of 3 years and 8 months
Number of postpartum hemorrhage (PPH) cases in which tranexamic acid (TXA) was administered for treatment of PPH/total number of PPH cases with blood loss\>500ml following vaginal or assisted delivery or \>1000ml following c-section delivery
Percentage of women with companionship at birth (3 months)
时间窗: From baseline through study completion, an average of 3 years and 8 months
Number of women who delivered in health facilities and were accompanied by their partners or other companions at birth/number of women who delivered in health facilities \*100
Progress toward interim goal for scaling up emergency obstetric and newborn care (EmONC) availability
时间窗: From baseline through study completion, an average of 3 years and 8 months
Number of facilities performing all emergency obstetric and newborn care (EmONC) signal functions/number of designated EmONC facilities\*100
Equipment, drugs & supplies
时间窗: From baseline through study completion, an average of 3 years and 8 months
Number of facilities with all tracer commodities/total number of facilities\*100
Emergency referral readiness
时间窗: From baseline through study completion, an average of 3 years and 8 months
Number of facilities meeting the criteria for essential emergency referral readiness/total number of facilities assessed\*100
Home to comprehensive emergency obstetric and newborn care (CEmONC) within 1 hour
时间窗: From baseline through study completion, an average of 3 years and 8 months
Number of people in a specified area able to access at least a comprehensive emergency obstetric and newborn care (CEmONC) facility within 1 hour travel time/total population in a specified area\*100
Health workforce adequate for caseload
时间窗: From baseline through study completion, an average of 3 years and 8 months
Number of facilities meeting caseload-specific staffing recommendations per shift/total number of facilities\*100
Facility maternal and perinatal death surveillance and review (MPDSR) implementation readiness
时间窗: From baseline through study completion, an average of 3 years and 8 months
Implementation readiness score (ranging from 0 to 30) based on the presence of key organizational attributes required to establish, integrate, and sustain maternal and perinatal death surveillance and response (MPDSR) processes. A higher score indicates a higher degree of MPDSR implementation readiness in a facility.
次要结局
未报告次要终点
研究者
Sarah Huber-Krum
Senior Epidemiologist
CDC Foundation