JMIR Publications

ABSTRACT

Background:

The postnatal period is a critical phase for maternal and newborn survival, during which many preventable complications and deaths occur; nevertheless, PNC utilization remains persistently low in Ethiopia. Women’s care-seeking and postpartum practices are shaped not only by knowledge but also by interacting cognitive, interpersonal, sociocultural, and environmental determinants, including perceived risk, self-efficacy, family influence, social norms, and culturally embedded beliefs. Existing educational interventions largely prioritize information provision and insufficiently address these determinants, limiting the translation of knowledge into timely PNC utilization and safe maternal and newborn care practices.

Objective:

This study aims to evaluate the effectiveness of a culturally tailored educational intervention for pregnant women, informed by Social Cognitive Theory and the Theory of Planned Behaviour, in improving PNC utilization and promoting safe maternal and newborn care practices in Ethiopia.

Methods:

A two-arm, assessor-blinded, open-label, matched-pair cluster-randomized superiority trial was conducted across 14 woredas in Jimma Zone, Ethiopia. A total of 28 health facilities were randomly allocated in a 1:1 ratio to the intervention and control arms. Pregnant women at 20–24 weeks of gestation were recruited from kebeles nested within the randomized health-facility clusters. Participants in the intervention arm received the educational intervention delivered by trained health extension workers, whereas those in the control arm received routine antenatal health education. The primary outcome is PNC utilization, and the secondary outcomes are newborn-care knowledge and practices. Primary analyses will follow the intention-to-treat principle. Mixed-effects regression models with random intercepts for health-facility clusters will be used to estimate intervention effects while accounting for intracluster correlation. Ethical clearance was obtained from the Ethics Committee in Switzerland on 22 September 2025 (AO_2025_00079) and from Jimma University [JUIH/IRB/0553/26]).

Results:

The study was funded by the Eckenstein-Geigy Professorship in June 2025. Participant recruitment was conducted between November 2025 and January 2026 across 28 health facilities in Jimma Zone, Ethiopia, resulting in the enrollment of 945 pregnant women. The intervention was delivered from December 2025 to May 2026, and participant follow-up was conducted from December 2025 to July 2026. Follow-up data collection was completed in July 2026, and data cleaning and statistical analysis began in the same month. The primary and secondary analyses are scheduled for completion in fall 2026, and the trial findings are expected to be submitted for publication in fall 2026.

Conclusions:

This trial will provide evidence on whether a culturally tailored, behavioural theory-informed educational intervention delivered during pregnancy can improve PNC utilization and promote safe maternal and newborn care practices in Ethiopia. The findings may inform the design and integration of context-responsive maternal and newborn health education within community-based health services. Clinical Trial: This trial is registered at ClinicalTrials.gov as NCT07095296; https://clinicaltrials.gov/study/NCT07095296?aggFilters=status:not