Evaluation of Comprehensive Emergency Obstetric and Neonatal Care Program in Malawi

Evaluation of a Program to Improve Comprehensive Emergency Obstetric Care and Maternal Health in Malawi

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Maternal and Child Health

Detailed Description

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 allows the evaluation to examine trends throughout implementation while minimizing duplication of data collection across assessment periods.

Registers, reports, patient files and other patient documentation serve as the primary source of clinical outcome data. Data abstraction will include labor and delivery registers, operating theater registers, maternity ward registers, admission and discharge records, inpatient newborn care registers, mortality registers, MPDSR documentation, and other facility records relevant to maternal and newborn care. Multiple data sources will be triangulated to improve completeness and accuracy of case ascertainment, particularly for obstetric complications and maternal and perinatal deaths.

The primary unit of analysis for health system indicators will be the health facility. For maternal and newborn outcome indicators, analyses will be conducted using all eligible deliveries and pregnancy outcomes occurring within participating facilities during each abstraction period. Selected population-based indicators, including institutional delivery rates, population cesarean section rates, and met need for emergency obstetric care, will be estimated using district population projections and expected births derived from national census and demographic survey data.

Standardized training, operating procedures, quality assurance processes, and electronic data collection systems will be used across all three rounds of data collection to ensure consistency and comparability over time. Identical methodologies will be employed at baseline, midline, and endline whenever feasible, allowing changes in facility readiness, implementation, and maternal and perinatal outcomes to be evaluated longitudinally across the program implementation period.

Data Collection Procedures

Data collection will be conducted at three time points over the five-year evaluation period: baseline (2026), midline (2028), and endline (2030). At each assessment, trained evaluation teams will visit participating health facilities to conduct health facility assessments, abstract routine health information from facility registers, review maternal and perinatal death surveillance and response (MPDSR) documentation, and conduct provider and client interviews at selected facilities. Standardized protocols, data collection instruments, and quality assurance procedures will be used across all evaluation rounds to ensure consistency and comparability over time.

The evaluation uses multiple complementary data collection approaches to comprehensively assess health facility readiness, emergency obstetric and newborn care (EmONC) service availability, quality of care, pregnancy outcomes, maternal and perinatal mortality, and implementation of maternal and perinatal death surveillance and response systems.

Health Facility Assessment (HFA)

The Health Facility Assessment (HFA) is a standardized questionnaire designed to evaluate facility readiness to provide routine maternal and newborn health services and emergency obstetric and newborn care. The questionnaire is adapted from internationally recognized assessment tools, including the Averting Maternal Death and Disability (AMDD) Health Facility Assessment and the NEST360 newborn care assessment, and has been modified for the Malawi context and current World Health Organization EmONC recommendations.

The HFA collects information on facility infrastructure, staffing, provider training, equipment, medicines, supplies, laboratory services, blood transfusion capability, operating theater capacity, referral and transport systems, communication systems, infection prevention practices, newborn care services, maternal and perinatal death surveillance and response (MPDSR), and performance of basic and comprehensive EmONC signal functions. Additional information is collected on facility workload, quality improvement activities, supervision, mentorship, and availability of clinical guidelines.

Questionnaires are administered face-to-face with facility staff who are most knowledgeable about the respective service areas. Whenever possible, responses are verified through direct observation of facility infrastructure, equipment, medicines, supplies, registers, and other documentation. Data are collected electronically using Android tablets programmed with CSPro software, which incorporates automated skip patterns, range checks, and consistency checks to improve data quality. Data are encrypted and uploaded daily to a secure cloud-based server.

Pregnancy Outcome Monitoring System (POMS)

The Pregnancy Outcome Monitoring System (POMS) is a standardized methodology developed by the CDC to systematically monitor pregnancy outcomes and obstetric complications using routinely documented health facility data. POMS abstracts information on all deliveries occurring during the evaluation period and links information across multiple facility registers to improve data completeness and accuracy.

The primary source of information is the labor and delivery register, from which trained abstractors collect maternal demographic information, pregnancy characteristics, mode of delivery, pregnancy outcome, maternal complications, neonatal outcomes, birthweight, Apgar scores, obstetric procedures, maternal and newborn treatments, and discharge outcomes.

To improve completeness, information recorded in labor and delivery registers is cross-checked with additional facility records, including operating theater registers, obstetric ward admission and discharge registers, postpartum registers, patient medical records, newborn care registers, nurses' and physicians' report books, daily ward reports, and other available clinical documentation. Up to three maternal complications are recorded for each woman, with the most immediately life-threatening complication listed first when multiple complications are present.

Information on obstetric surgical procedures, including cesarean deliveries, hysterectomies, laparotomies, surgery for ectopic pregnancy, and procedures related to abortion complications, is matched to individual pregnancy records whenever possible. Aggregate information on spontaneous and induced abortions is also abstracted from relevant facility registers.

Retrospective pregnancy outcome data will be abstracted during each evaluation round. The baseline assessment will include approximately 18 months of pregnancy outcomes preceding program implementation. The midline assessment will abstract pregnancy outcomes occurring during the subsequent implementation period, while the endline assessment will include the final 24 months of program implementation. This approach permits assessment of changes over time while minimizing duplication of data collection.

Rapid Ascertainment Process of Institutional Deaths (RAPID)

The Rapid Ascertainment Process of Institutional Deaths (RAPID) is a validated methodology designed to improve identification of maternal and perinatal deaths occurring within health facilities. Because maternal deaths are frequently underreported in routine maternity registers, RAPID systematically reviews multiple facility data sources to identify deaths that may otherwise be missed.

For maternal deaths, evaluation teams review records documenting deaths among women of reproductive age throughout the facility, including labor and delivery registers, obstetric and gynecology ward admission and discharge registers, operating theater registers, death registers, morgue registers, maternal death review forms, and other available records. Information collected includes demographic characteristics, pregnancy status, diagnoses, obstetric complications, treatments received, procedures performed, and documented causes of death. Each death is reviewed to determine whether it meets the definition of a maternal death.

The RAPID methodology is also used to identify perinatal deaths through systematic review of labor and delivery registers, obstetric wards, newborn care units, operating theater registers, morgue registers, and other available documentation. Detailed information on stillbirths and neonatal deaths is abstracted to improve completeness of facility-based mortality data.

Following abstraction, RAPID records are cross-checked with POMS data to identify duplicate records and ensure complete ascertainment of maternal and perinatal deaths. Maternal and perinatal deaths identified only through RAPID are incorporated into the final analytic database.

Maternal and Perinatal Death Surveillance and Response (MPDSR)

The evaluation includes an assessment of facility readiness to implement and sustain Maternal and Perinatal Death Surveillance and Response (MPDSR) systems. Information is collected through the Health Facility Assessment and structured review of maternal and perinatal death review documentation.

The HFA assesses organizational structures and processes that support MPDSR implementation, including committee composition, meeting frequency, staff participation, review practices, documentation, implementation of recommendations, and integration of MPDSR into routine facility activities. Additional abstraction of maternal and perinatal death review forms and committee records will evaluate the completeness of reviews, identification of contributing factors, development of recommendations, implementation of corrective actions, and follow-up of recommendations.

Facilities will be classified according to a standardized implementation readiness framework that assesses progression from early adoption through routine practice, institutional integration, and sustainable implementation of MPDSR.

Provider and Key Informant Interviews

Provider and key informant interviews will be conducted at selected facilities to collect information on provider skills, training, experiences, and clinical practices related to maternal and newborn care. We anticipate interviewing 156 key informants and more than 200 providers. The interviews will provide additional information on practices that may not be captured through facility assessments or routine health records.

Data Quality Assurance

Comprehensive quality assurance procedures will be implemented throughout data collection. All data collectors will receive standardized training on study procedures, ethical conduct of research, interview techniques, register abstraction, standardized definitions of obstetric complications and interventions, and electronic data collection procedures. Pre-testing of study instruments and field procedures will be conducted before each round of data collection.

Electronic data collection systems include programmed skip logic, range checks, and automated consistency checks to minimize data entry errors. Field supervisors will routinely review completed questionnaires and abstraction forms for completeness and accuracy and provide feedback to data collection teams throughout fieldwork. Pregnancy outcome data abstracted through POMS will be routinely triangulated with RAPID and other facility registers to maximize completeness and improve ascertainment of maternal and perinatal outcomes. Standard operating procedures will be followed across all participating facilities to ensure consistent implementation of evaluation activities and comparability of findings across districts and over time.

Data Management, Analysis, Ethics, and Dissemination Data Management

Data will be collected electronically using Android tablets programmed with CSPro software for the Health Facility Assessment (HFA) and standardized abstraction tools for Pregnancy Outcome Monitoring System (POMS), Rapid Ascertainment Process of Institutional Deaths (RAPID), provider interviews, and other study instruments. Electronic questionnaires include programmed skip patterns, range checks, consistency checks, and required fields to improve data quality during data collection.

Completed questionnaires will be encrypted and uploaded daily to a secure, password-protected cloud-based server. Data will be removed from tablets following successful synchronization to minimize the risk of unauthorized access. Data collectors and supervisors will conduct routine quality control procedures throughout fieldwork, including review of completed questionnaires, verification of register abstractions, and resolution of discrepancies while still at participating facilities whenever possible.

Routine data cleaning will be conducted following each round of data collection. Quality assurance procedures will include evaluation of missing data, logical consistency checks, duplicate record identification, verification of outliers, and reconciliation of discrepancies identified through triangulation across multiple facility registers. Pregnancy outcome data abstracted through POMS will be cross-checked with RAPID data and other facility records to maximize completeness and improve ascertainment of maternal and perinatal outcomes. Final analytic datasets will be de-identified prior to analysis, and access to study data will be restricted to authorized study personnel.

Statistical Analysis

Analyses will be conducted separately for each evaluation time point and will compare findings across baseline, midline, and endline assessments to evaluate changes over time. The primary unit of analysis for health system indicators will be the health facility, while maternal and newborn outcome indicators will be calculated using all eligible deliveries occurring within participating facilities during each abstraction period.

Descriptive statistics will summarize facility characteristics, health workforce capacity, infrastructure, equipment, medicines, supplies, service availability, referral systems, MPDSR implementation, and performance of emergency obstetric and newborn care signal functions. Categorical variables will be summarized using frequencies and percentages, while continuous variables will be summarized using appropriate measures of central tendency and variability.

Routine facility data abstracted through POMS and RAPID will be used to estimate maternal and newborn health indicators, including institutional delivery rates, obstetric complications, cesarean delivery rates, maternal mortality, stillbirths, neonatal mortality, obstetric case fatality rates, and other indicators of emergency obstetric and newborn care performance. Maternal and perinatal deaths identified through RAPID will be incorporated into the final analytic dataset to improve completeness of mortality estimates.

For selected indicators requiring population-based denominators, including institutional delivery rates, population cesarean section rates, and met need for emergency obstetric care, expected numbers of births will be estimated using district population projections derived from the 2018 Malawi Population and Housing Census and age-specific fertility rates from the 2024 Malawi Demographic and Health Survey. These estimates will permit calculation of population-based indicators that extend beyond facility-level service statistics.

Facility readiness for Maternal and Perinatal Death Surveillance and Response (MPDSR) will be assessed using a standardized implementation readiness framework that evaluates organizational structures and practices required to establish, implement, integrate, and sustain MPDSR systems. Composite readiness scores will be calculated based on predefined implementation attributes and facilities will be classified according to implementation phase, including early adoption, evidence of practice, integrated practice, and sustainable practice.

Changes in facility readiness, service availability, implementation of MPDSR, and maternal and perinatal health outcomes will be examined across the three evaluation periods. Results will be presented overall and, where appropriate, stratified by district and facility level to identify variation in implementation and outcomes across different health system settings.

Ethical Considerations

The study protocol has been reviewed and approved by the appropriate institutional and national ethics review committees prior to initiation of data collection. Administrative approval was obtained from the Malawi Ministry of Health and relevant regional and district health authorities before facility visits are conducted.

Before data collection begins at each facility, written informed consent will be obtained from the facility in-charge. At larger facilities, written informed consent will also be obtained from ward in-charges or other responsible departmental leaders participating in the Health Facility Assessment. Data collectors will explain the purpose of the evaluation, study procedures, potential risks and benefits, confidentiality protections, and voluntary nature of participation. Participants will have the opportunity to ask questions before providing written informed consent.

Provider and client interviews will also be conducted only after obtaining informed consent from individual participants. Participation is voluntary, and participants may decline to answer any question or withdraw from the interview at any time without penalty.

The evaluation primarily utilizes routinely documented health facility records. No patient names, medical record numbers, or other direct personal identifiers will be entered into study databases. During register abstraction, only information necessary to calculate study indicators will be collected. When needed to resolve discrepancies during data verification, digital photographs of register pages may be temporarily retained solely for quality assurance purposes and will not include identifiable information in the final analytic database.

All electronic study data will be stored on secure, password-protected servers with access restricted to authorized study personnel. Signed consent forms will be stored separately from study data in secure locked locations. All study personnel will receive training in research ethics, informed consent procedures, confidentiality, and data security before participating in data collection activities.

Because this evaluation is designed to assess implementation of a health systems strengthening program using facility assessments and routinely documented health information, the study presents minimal risk to participants. Findings will be reported only in aggregate form to prevent identification of individual facilities, healthcare providers, or patients.

Dissemination of Findings

Study findings will be shared with the Malawi Ministry of Health, district health management teams, implementing partners, healthcare facilities, Bloomberg Philanthropies, and other key stakeholders throughout the evaluation period. Results from baseline, midline, and endline assessments will be used to inform ongoing program implementation, identify opportunities for quality improvement, and support evidence-based decision-making.

Evaluation findings will be disseminated through technical reports, policy briefs, stakeholder meetings, scientific conference presentations, and peer-reviewed publications. Facility-level and district-level reports will be prepared to provide participating facilities and health authorities with actionable information regarding health facility readiness, emergency obstetric and newborn care capacity, maternal and perinatal outcomes, and implementation of maternal and perinatal death surveillance and response systems.

The evaluation is intended to strengthen national monitoring and evaluation capacity while contributing to the global evidence base on effective approaches for improving maternal and newborn health through health systems strengthening. Lessons learned from this evaluation may inform future maternal and newborn health programs in Malawi and other low-resource settings implementing similar emergency obstetric and newborn care interventions.

• Study Type: Observational
• Enrollment (Estimated): 78

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This evaluation will be conducted in all health facilities Lilongwe and Blantyre Districts in Malawi that provide maternity care. At each assessment, health facility readiness will be evaluated using a standardized Health Facility Assessment (HFA), and retrospective facility-based pregnancy outcome data from the preceding 18-24 months will be collected using the Pregnancy Outcomes Monitoring System (POMS) and the Rapid Ascertainment Process of Institutional Deaths (RAPID).

Description

Inclusion Criteria:

- Health facilities that report an average of at least 120 deliveries per year

Exclusion Criteria:

• Health facilities that do not provide maternity care
• Health facilities that do not report an average of at least 120 deliveries per year

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Health facilities; 78 health facilities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Availability of EmONC	The number of facilities providing EmONC per 500,000 total population	From baseline through study completion, an average of 5 years
Institutional delivery rate	The number of women who delivered in health facilities divided by the expected number of live births in the area of observation	From baseline through study completion, an average of 5 years
Proportion of all births in EmONC facilities	The number of women who delivered in EmONC facilities divided by the expected number of live births in the area of observation	From baseline through study completion, an average of 5 years
Institutional C-section rate	Number of women who delivered by c-section/number of women who gave birth in health facilities *100 per yr	From baseline through study completion, an average of 5 years
Population-based C-section rate	Number of women who delivered by c-section/estimated number of women who gave birth within a year*100 per yr	From baseline through study completion, an average of 5 years
Direct obstetric case fatality rate	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	From baseline through study completion, an average of 5 years
Institutional maternal mortality ratio	Number of institutional maternal deaths/number of institutional live births*100,000 per yr	From baseline through study completion, an average of 5 years
Institutional maternal mortality ratio due to PPH	Number of institutional maternal deaths due to PPH/number of institutional live births*100,000 per yr	From baseline through study completion, an average of 5 years
PPH-specific case fatality rate	Number of women who died from PPH in health facilities/number of women experiencing PPH in health facilities*100 per yr	From baseline through study completion, an average of 5 years
Institutional intrapartum stillbirth rate	Number of institutional intrapartum stillbirths/number of institutional births (live births + stillbirths) *1000 per yr	From baseline through study completion, an average of 5 years
Institutional perinatal mortality rate	Number of institutional intrapartum and early neonatal deaths/number of institutional births (live births + stillbirths) *1000 per yr	From baseline through study completion, an average of 5 years
Institutional neonatal mortality rate	Number of institutional neonatal deaths 0-28 days/number of institutional live births*1000	From baseline through study completion, an average of 5 years
Birth-weight specific institutional neonatal mortality rates	Number of deaths to newborns with birthweight of <1000 g, 1000-1499, 1500-2499, and 2500+ /number of newborns in corresponding birth category*1000	From baseline through study completion, an average of 5 years
Met need for obstetric care	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	From baseline through study completion, an average of 5 years
Percentage of vaginal or assisted deliveries in which calibrated drapes were used	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	From baseline through study completion, an average of 5 years
Percentage of women who received prophylactic uterotonic (oxytocin, ergometrine, or misoprostol) during the third stage of labor	Number of women who received prophylactic uterotonic (oxytocin, carbetocin, or misoprostol) during the third stage /number of women who delivered in the health facility	From baseline through study completion, an average of 5 years
Percentage of PPH cases in which TXA was administered for treatment of PPH	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	From baseline through study completion, an average of 5 years
Percentage of women with companionship at birth (3 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	From baseline through study completion, an average of 5 years
Progress toward interim goal for scaling up EmONC availability	Number of facilities performing all EmONC signal functions/number of designated EmONC facilities*100	From baseline through study completion, an average of 5 years
Equipment, drugs & supplies	Number of facilities with all tracer commodities/total number of facilities*100	From baseline through study completion, an average of 5 years
Emergency referral readiness	Number of facilities meeting the criteria for essential emergency referral readiness/total number of facilities assessed*100	From baseline through study completion, an average of 5 years
Home to Comprehensive EmONC within 1 hour	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	From baseline through study completion, an average of 5 years
Health workforce adequate for caseload	Number of facilities meeting caseload-specific staffing recommendations per shift/total number of facilities*100	From baseline through study completion, an average of 5 years
Facility MPDSR implementation readiness	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	From baseline through study completion, an average of 5 years

Collaborators and Investigators

• Sponsor: CDC Foundation

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030

Study Registration Dates

• First Submitted: July 16, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Maternal Child Health
• Other Study ID Numbers: 10100407_5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No