A Culturally Tailored, Behavioral Theory–Informed Educational Intervention for Pregnant Women to Improve Postnatal Care Use and Safe Maternal and Newborn Care Practices in Ethiopia: Protocol for a Cluster Randomized Controlled Trial

Abstract Background The postnatal period is a critical phase for maternal and newborn survival, during which many preventable complications and deaths occur, yet postnatal care (PNC) use remains low in Ethiopia. Care-seeking and postpartum practices are shaped by knowledge and 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 use 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 (SCT) and the Theory of Planned Behavior (TPB), in improving PNC use and promoting safe maternal and newborn care practices in Ethiopia. Methods A 2-arm, assessor-blinded, open-label, matched-pair cluster randomized controlled 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 to 24 weeks of gestation were recruited from kebeles 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 was PNC use; secondary outcomes were 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. Results The study was funded by the Eckenstein-Geigy Professorship in June 2025. From November 2025 to January 2026, 945 pregnant women were enrolled across 28 health facilities in Jimma Zone, Ethiopia. The intervention was delivered from December 2025 to May 2026, with follow-up 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. The mean age of participants was 26.84 years (SD 5.23), with the majority residing in rural areas (n=834, 88.3%) and being married (n=937, 99.2%). Baseline characteristics were generally similar between trial arms regarding age, residence, marital status, and obstetric history, although notable differences were observed in maternal occupation, educational attainment, and household income. Conclusions This trial will provide evidence on whether a culturally tailored, behavioral theory–informed educational intervention delivered during pregnancy can improve PNC use 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.