Importance: Infections and complications following cesarean delivery are a significant source of maternal mortality in Ethiopia.
Objective: To study the effectiveness of a program to strengthen compliance with perioperative standards and reduce postoperative complications following cesarean delivery.
Design, setting, and participants: This stepped-wedge cluster randomized clinical trial included patients undergoing cesarean delivery from August 24, 2021, to January 31, 2023, at 9 hospitals organized into 5 clusters in Ethiopia.
Intervention: Clean Cut, a multimodal surgical quality improvement program that includes process-mapping 6 perioperative standards and creating site-specific, systems-level improvements. The control period was the period before implementation of the intervention.
Main outcomes and measures: The primary end point was surgical site infection rate, and secondary end points were maternal mortality and perinatal mortality and a composite outcome of infections and both mortality outcomes. All were assessed at 30 days postoperatively in the intervention and control groups, adjusting for clustering and demographics. Compliance with standards and the relationship between compliance and outcomes were also compared between the 2 arms.
Results: Among 9755 women undergoing cesarean delivery, 5099 deliveries (52.3%) occurred during the control period (2722 emergency cases [53.4%]) and 4656 (47.7%) during the intervention period (2346 emergency cases [50.4%]). Mean (SD) patient age was 27.04 (0.05) years. Thirty-day follow-up was completed for 5153 patients (52.8%). No significant reduction in infection rates was detected after the intervention (OR, 0.84; 95% CI, 0.55-1.27; P = .40). Intraoperative infection prevention standards improved significantly in the intervention arm vs control arm for compliance with at least 5 of the 6 standards (odds ratio [OR], 2.95; 95% CI, 2.40-3.62; P < .001). Regardless of trial arm, high compliance was associated with reduced odds of maternal (OR, 0.32; 95% CI, 0.11-0.93; P = .04) and perinatal (OR, 0.64; 95% CI, 0.47-0.89; P = .008) mortality.
Conclusions and relevance: In this stepped-wedge cluster randomized clinical trial of patients undergoing cesarean delivery, no significant reductions in surgical site infections were observed. However, compliance with perioperative standards improved following the intervention.
Trial registration: ClinicalTrials.gov Identifier: NCT04812522; Pan-African Clinical Trials Registry Identifier: PACTR202108717887402.