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 health status. Their progress, however, has been minimal and uneven across countries. The continuum of care is a key to strengthening maternal, newborn, and child health. In this context, the Japanese government launched the Ghana Ensure Mothers and Babies Regular Access to Care (EMBRACE) Implementation Research Project in collaboration with the Ghanaian government. This study aims to evaluate the implementation process and effects of an intervention 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-implementation hybrid design in Dodowa, Kintampo, and Navrongo, Ghana. We will provide an intervention package to women living in randomly allocated intervention clusters. The study population is women of reproductive age between the ages of 15 and 49 years. The package includes: 1) use of a new continuum of care card, 2) continuum of care orientation 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 intervention and implementation impacts. The intervention outcomes are continuum of care completion rate, rate of postnatal care within 48 hours, complication rate requiring mothers' and newborns' hospitalizations, and perinatal and neonatal mortality. The implementation outcomes are intervention coverage of the target population, intervention adoption and fidelity, implementation cost, and sustainability. Discussion: In this trial, we will investigate how successful continuum of care can contribute to improving maternal, newborn, and child health outcomes. If successful, this model will then be implemented further in Ghana and other neighboring countries. Trial registration: Current Controlled Trials ISRCTN90618993. Registered on 3 September 2014.