BabyGel pilot: a pilot cluster randomised trial of the provision of alcohol handgel to postpartum mothers to prevent neonatal and young infant infection-related morbidity in the community.

Background: Alcohol-based hand rub (ABHR) is widely used in both health and social facilities to prevent infection, but it is not known whether supplying it for regular perinatal use can prevent newborn sepsis in African rural homes. Our study piloted a cluster randomised trial of providing ABHR to postpartum mothers to prevent neonatal infection-related morbidity in the communities.

Methods: We conducted a pilot parallel cluster randomised controlled trial across ten villages (clusters) in rural Eastern Uganda.

Optimising informed consent for participants in a randomised controlled trial in rural Uganda: a comparative prospective cohort mixed-methods study.

Background: Poor participant understanding of research information can be a problem in community interventional studies with rural African women, whose levels of illiteracy are high. This study aimed to improve the informed consent process for women living in rural eastern Uganda. We assessed the impact of alternative consent models on participants' understanding of clinical trial information and their contribution to the informed consent process in rural Uganda.