A Perioperative Quality Improvement Program for Cesarean Delivery in Ethiopia: A Stepped-Wedge Cluster Randomized Clinical Trial.

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.

Evaluation of an adaptive, multimodal intervention to reduce postoperative infections following cesarean delivery in Ethiopia: study protocol of the CLEAN-CS cluster-randomized stepped wedge interventional trial.

BACKGROUND: We previously developed and pilot tested Clean Cut, a program to prevent postoperative infections by improving compliance with the WHO Surgical Safety Checklist (SSC) and strengthening adherence to infection control practices. This protocol describes the CheckList Expansion for Antisepsis and iNfection Control in Cesarean Section (CLEAN-CS) trial evaluating our program's ability to reduce infections following CS and other obstetric and gynecological operations in Ethiopia. METHODS/DESIGN: CLEAN-CS is a cluster-randomized stepped wedge interventional trial with five clusters (two hospitals per cluster). It aims to assess the impact of Clean Cut on six critical perioperative infection prevention standards including antiseptic practices, antibiotic administration, and routine SCC use. The trial involves baseline data collection followed by Clean Cut training and implementation in each cluster in randomized order. The intervention consists of (1) modifying and implementing the SSC to fit local practices, (2) process mapping each standard, (3) coupling data and processes with site-specific action plans for improvement, and (4) targeted training focused on process gaps. The primary outcome is 30-day CS infection rates; secondary outcomes include other patient-level complications and compliance with standards. Assuming baseline SSI incidence of 12%, an effect size of 25% absolute reduction, and the ability to recruit 80-90 patients per cluster per month, we require a sample of 8100 patients for significance. We will report our study according to CONSORT. DISCUSSION: A cluster-randomized stepped wedge design is well-suited for evaluating this type of surgical safety program. The targeted standards are not in doubt, yet compliance is frequently difficult. Solutions are available and may be recognized by individuals, but teams dedicated to improvement are often lacking. Clean Cut was successfully piloted but requires a more rigorous methodological assessment. We seek to understand the qualities, characteristics, and resources needed to implement the program, the magnitude of effect on processes and outcomes, and to what degree it can enhance compliance with care standards. Challenges include a fraught social and political environment, pandemic travel restrictions, and a limited budget. TRIAL REGISTRATION: ClinicalTrials.gov NCT04812522 (registered on March 23, 2021); Pan-African Clinical Trials Registry PACTR202108717887402 (registered on August 24, 2021).