Evaluation of Comprehensive Emergency Obstetric and Neonatal Care Program in Malawi

NCT07727928 | Not Yet Recruiting

• 1 other identifier: 10100407_5
• Study Type: observational
• Target: 78
• Locations: 0 countries
• Sites: N/A

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:

• 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.

Conditions

Maternal and Child Health

Keywords

Maternal Child Health

Outcome Measures

Primary Outcomes (24)

• Availability of emergency obstetric and newborn care (EmONC)

  The number of facilities providing emergency obstetric and newborn care (EmONC) per 500,000 total population

  From baseline through study completion, an average of 3 years and 8 months

• 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 3 years and 8 months

• 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 3 years and 8 months

• 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 3 years and 8 months

• 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 3 years and 8 months

• 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 3 years and 8 months

• 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 3 years and 8 months

• Institutional maternal mortality ratio due to postpartum hemorrhage (PPH)

  Number of institutional maternal deaths due to postpartum hemorrhage (PPH) /number of institutional live births\*100,000 per yr

  From baseline through study completion, an average of 3 years and 8 months

• Postpartum hemorrhage (PPH)-specific case fatality rate

  Number of women who died from postpartum hemorrhage (PPH) in health facilities/number of women experiencing PPH in health facilities\*100 per yr

  From baseline through study completion, an average of 3 years and 8 months

• 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 3 years and 8 months

• 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 3 years and 8 months

• 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 3 years and 8 months

• 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 3 years and 8 months

• 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 3 years and 8 months

• 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 3 years and 8 months

• 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 3 years and 8 months

• Percentage of postpartum hemorrhage (PPH) cases in which tranexamic acid (TXA) was administered for treatment of PPH

  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

  From baseline through study completion, an average of 3 years and 8 months

• 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 3 years and 8 months

• Progress toward interim goal for scaling up emergency obstetric and newborn care (EmONC) availability

  Number of facilities performing all emergency obstetric and newborn care (EmONC) signal functions/number of designated EmONC facilities\*100

  From baseline through study completion, an average of 3 years and 8 months

• Equipment, drugs & supplies

  Number of facilities with all tracer commodities/total number of facilities\*100

  From baseline through study completion, an average of 3 years and 8 months

• 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 3 years and 8 months

• Home to comprehensive emergency obstetric and newborn care (CEmONC) within 1 hour

  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

  From baseline through study completion, an average of 3 years and 8 months

• 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 3 years and 8 months

• Facility maternal and perinatal death surveillance and review (MPDSR) implementation readiness

  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.

  From baseline through study completion, an average of 3 years and 8 months

Study Arms (1)

Health facilities

78 health facilities

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• CDC Foundation: lead

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Epidemiologist

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 27, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share