Evaluation of an mHealth-CHW Tool for Post-c-section Follow-up in Rural Rwanda

Cesarean sections (c-sections) are one of the most common surgical procedures done globally. However, there has been an increase in the number of c-section related complications. Women who deliver via c-section are nearly twice as likely to experience a complication (not including hemorrhage) as compared to women who deliver vaginally. One of the most commonly reported postoperative complications is surgical site infections (SSIs) - in this case, an infection of the c-section wound - with the highest rates of infection globally being in African regions (11.91%). In Rwanda, patients receive verbal instructions after surgery to return to the hospital should they experience an SSI or other complication. However, there is often patient delay in identification of complications and return to care, which increases rates of morbidity (illness) and mortality (death) from post c-section complications. The investigators think that if patient follow-up after operation is improved, this may reduce the impact of complications on patient health and well-being. This research is being done to evaluate the mHealth-CHW tool developed to support comprehensive home-based follow-up by community health workers (CHWs). Patients who have had c-section at Kirehe District Hospital will be recruited for this study, and will be randomly assigned to one of two groups: the intervention for home follow-up using the mHealth-CHW tool (referred to as Arm 1) or the standard of care (referred to as Arm 2). Individuals assigned to Arm 1 will be visited at home twice by a study CHW (sCHW) using the mHealth-CHW tool. They may be instructed to return to the health center for care based on the visit using the mHealth-CHW tool. Individuals in Arm 2 will follow the current standard of care and will be instructed to return to a health center every few days for follow-up until instructed otherwise. Regardless of the arm assignment, all participants will be instructed to return to Kirehe District Hospital 30 days after the date of their operation for a study clinic. At this study clinic they will undergo physical exam by a general practitioner (the healthcare provider who typically sees patients post c-section at the hospital level in Rwanda) and the study team will ask questions regarding financial expenditure for us to understand the rate of financial catastrophe experienced by both groups.

NCT Number	NCT07369700
Lead Sponsor	University of North Carolina, Chapel Hill Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Partners in Health
Conditions	Surgical Site Infection Following Cesarean Delivery, Cesarean Section Complications
Enrollment	1,350 participants
Start Date	2026-04-22
Primary Completion	2029-02 (estimated)
Study Completion	2029-02 (estimated)
Updated on ClinicalTrials.gov	2026-04-29