Ghana’s Ensure Mothers and Babies Regular Access to Care (EMBRACE) program: study protocol for a cluster randomized controlled trial

Background: The United Nations’ Millennium Development Goals call for improving maternal and child healthstatus. Their progress, however, has been minimal and uneven across countries. The continuum of care is a key tostrengthening maternal, newborn, and child health. In this context, the Japanese government launched the GhanaEnsure Mothers and Babies Regular Access to Care (EMBRACE) Implementation Research Project in collaborationwith the Ghanaian government. This study aims to evaluate the implementation process and effects of anintervention to increase the continuum of care for maternal, newborn, and child health status in Ghana.Methods/Design: We will conduct a cluster randomized controlled trial using an effectiveness-implementationhybrid design in Dodowa, Kintampo, and Navrongo, Ghana. We will provide an intervention package to womenliving in randomly allocated intervention clusters. The study population is women of reproductive age betweenthe ages of 15 and 49 years. The package includes: 1) use of a new continuum of care card, 2) continuum of careorientation for health workers, 3) 24-hour health facility retention of mothers and newborns after delivery, and 4)postnatal care by home visits. We will measure maternal, newborn, and child health outcomes for both interventionand implementation impacts. The intervention outcomes are continuum of care completion rate, rate of postnatalcare within 48 hours, complication rate requiring mothers\u27 and newborns\u27 hospitalizations, and perinatal andneonatal mortality. The implementation outcomes are intervention coverage of the target population, interventionadoption and fidelity, implementation cost, and sustainability.Discussion: In this trial, we will investigate how successful continuum of care can contribute to improvingmaternal, newborn, and child health outcomes. If successful, this model will then be implemented further in Ghanaand other neighboring countries