In conducting this study, we will follow the key principles of ethical conduct of research. In the current proposal, we propose to conduct an intervention that we are not certain will work at scale, nor are we certain of the impact (i.e. there is equipoise). Another key ethical concern is beneficence and justice. The intervention is not invasive and no risks to patients are expected. This intervention may in fact benefit the most vulnerable populations, such as pregnant women and newborn babies. Within this group, it is mainly designed to ensure the poorest can access health care delivery, in case of danger signs, or in case of a sick baby. Efforts will be made to improve health units to support referral in both intervention and control areas.

A rigorous consent process will be put in place. Approval will be obtained from the district health teams and from the local communities including community groups, traditional birth attendants, and community leaders following a detailed sensitization about the goals and objectives of the study, the implementation strategy and the evaluation processes. For the evaluation component, informed consent will be requested from study subjects and the local community, and confidentiality will be assured. No patient-specific data will be collected apart from aggregated figures (e.g. such as the number of women delivering at health facilities). This data will be collected from registers, which are routinely maintained by health facilities. In addition, such data will be restricted to the medical care staff and the investigators directly involved in the study, and the study team records no names. During the study period, anybody in the community found sick by the study team will be referred appropriately.

For the evaluation stage of the intervention, uptake and mortality surveillance consent will not be sought from the subjects. The subjects will be free to accept or refuse, and where necessary, women will be free to consult with their husbands and/or community members before consenting. The Safe Deliveries study and the Uganda Newborn Estimated Survival Time (UNEST) already have ethical approval from the Makerere University School of Public Health (MUSPH) Institutional Review Board (IRB) and from the Uganda National Council for Science and Technology (UNCST). The current protocol will again be submitted to the same bodies for amendment of ethical approvals. The study will continue using the existing Data Monitoring and Advisory Board, which has been serving both the Safe Deliveries study and UNEST. The DMSB members are local experts, all with PhDs in their respective fields of specialty, and have strong policy linkages. The DSMB will meet annually. The study will be registered as a trial both locally and internationally.