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

NCT07369700 | Enrolling By Invitation

• 3 other identifiers: 25-2585R33HD103052IRB25-2528
• Study Type: interventional
• Target: 1,350
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cesarean Section Complications; Surgical Site Infection Following Cesarean Delivery

Outcome Measures

Primary Outcomes (2)

• Time-to-diagnosis for complications

  For time-to-diagnosis, for each woman with an identified complication, time-to-diagnosis will be date from cesarean to date of diagnosis, either at the health center or at the hospital study clinic visit. Complications after the study clinic visit will be excluded. Assessments at the health center and/or study clinic will provide a clinical validation of the findings.

  From enrollment to the time of participation at the study clinic (30 days post operation)

• Completion of intervention steps (follow-up using mHealth-CHW tool)

  For completion of intervention steps in mHealth-CHW tool, the investigators will report the proportion of visits with all steps completed. A visit is considered complete if all steps above were successfully completed within one hour of the study community health worker (sCHW) arriving at the home. The steps included are: Being able to find patients home. Participant willing to have physical exam by sCHW. The sCHW completed the basic assessment as guided by the tool. The sCHW completed the photo-based SSI diagnosis as guided by the tool. The sCHW provided general counseling and follow-up instructions as guided by the tool. The full home screening was completed. Phone could turn on. Phone did not shut down during interaction. Phone maintained charge. If needed, was the phone successfully recharged in field. Data from screening successfully stored.

  5 (±1 day) and 10 (±1 day) days post c-section

Secondary Outcomes (2)

• Cesarean-associated complications (mHealth-CHW tool)

  From enrollment to the time of participation at the study clinic (30 days post operation)

• Financial catastrophe

  From enrollment to the time of participation at the study clinic (30 days post operation)

Study Arms (2)

Standard-of-care

NO INTERVENTION

Individuals randomized to this arm will receive the standard of care for women recovering from c-section in Rwanda, which is guidance to return to their nearest health center every few days for check up until advised otherwise.

Intervention, mHealth-CHW tool

EXPERIMENTAL

Individuals in this arm will receive the intervention, whereby they will be followed up at postoperative days 5 and 10 at their homes by a study community health worker (sCHW) using the mHealth-CHW tool. When using this tool, individuals will be asked a series of yes-no questions inquiring about symptoms which may indicate potential post c-section complications, and have a picture of their c-section wounds captured using the tool, which would predict whether the wound is infected or not. The sCHW would then relay the guidance produced by the app, which may be that the individual can continue to recover safely at home or that they should seek help at their nearest health facility for the identified symptoms.

Behavioral: mHealth Community Health Worker Intervention for post-cesarean follow up

Interventions

mHealth Community Health Worker Intervention for post-cesarean follow up BEHAVIORAL

Individuals will be followed up at postoperative days 5 and 10 at their homes by a study community health worker (sCHW) using the mHealth-CHW tool. When using this tool, individuals will be asked a series of yes-no questions inquiring about symptoms which may indicate potential post c-section complications, and have a picture of their c-section wounds captured using the tool, which would predict whether the wound is infected or not. The sCHW would then relay the guidance produced by the app, which may be that the individual can continue to recover safely at home or that they should seek help at their nearest health facility for the identified symptoms.

Intervention, mHealth-CHW tool

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Had cesarean delivery at Kirehe District Hospital (KDH), Rwanda; resident of Kirehe District, Rwanda

You may not qualify if:

• Did not have cesarean delivery at KDH; not resident of Kirehe District; residence in Mahama refugee camp

Sponsors & Collaborators

• Partners in Health: collaborator
• University of North Carolina, Chapel Hill: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Kirehe District Hospital

Kirehe, Kirehe, 00000, Rwanda

Location

Study Officials

• Bethany Hedt-Gauthier, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Random assignment - participants will be randomly assigned to an arm, and both participants and study team members will not know what the assignment is until the day the participant is to be discharged from the hospital.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: January 27, 2026
• Study Start: April 22, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 9 months after and continuing for 36 months following publication
• Access Criteria: If approved by Rwanda government, data will be made available in a publicly available repository.

Locations

RW (1)