NCT07727928Not yet recruitingNot Applicable

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

CDC Foundation0 sites78 target enrollmentStarted: July 1, 2026Last updated: July 28, 2026

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Not yet recruiting
Sponsor
Enrollment: 78
Primary Endpoint: Availability of EmONC

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

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.

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.

Study Design

Study Type: Observational
Observational Model: Other
Time Perspective: Retrospective

Eligibility Criteria

Sex: All
Accepts Healthy Volunteers: No

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

Arms & Interventions

Health facilities

78 health facilities

Outcomes

Primary Outcomes

Availability of EmONC

Time Frame: From baseline through study completion, an average of 5 years

The number of facilities providing EmONC per 500,000 total population

Institutional delivery rate

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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)