Department of Surgery, Addis Ababa University, Addis Ababa, Ethiopia.
Lifebox Foundation, Addis Ababa, Ethiopia.
JAMA Netw Open. 2024 Aug 1;7(8):e2428910. doi: 10.1001/jamanetworkopen.2024.28910.
Infections and complications following cesarean delivery are a significant source of maternal mortality in Ethiopia.
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.
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.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT04812522; Pan-African Clinical Trials Registry Identifier: PACTR202108717887402.
在埃塞俄比亚，剖宫产术后感染和并发症是产妇死亡的一个重要原因。
研究一项旨在加强围手术期标准遵守并降低剖宫产术后并发症的计划的有效性。
设计、设置和参与者：这项阶梯式楔形集群随机临床试验纳入了 2021 年 8 月 24 日至 2023 年 1 月 31 日期间在埃塞俄比亚的 9 家医院接受剖宫产手术的患者，这些医院分为 5 个集群。
Clean Cut 是一种多模式的手术质量改进计划，包括对 6 项围手术期标准进行流程映射，并制定特定于地点的系统层面的改进措施。对照期是干预实施前的时期。
主要终点是手术部位感染率，次要终点是产妇死亡率和围产期死亡率以及感染和两种死亡率结局的复合结局。所有结局均在干预组和对照组的术后 30 天进行评估，同时考虑了聚类和人口统计学因素。还比较了两组之间的标准遵守情况以及遵守情况与结局之间的关系。
在 9755 名接受剖宫产手术的妇女中，5099 例（52.3%）在对照期（2722 例紧急病例[53.4%]）进行，4656 例（47.7%）在干预期（2346 例紧急病例[50.4%]）进行。患者的平均（SD）年龄为 27.04（0.05）岁。5153 名患者（52.8%）完成了 30 天随访。干预后未发现感染率显著降低（比值比，0.84；95%CI，0.55-1.27；P=0.40）。与对照组相比，干预组术中感染预防标准的遵守情况显著改善，至少遵守了 6 项标准中的 5 项（优势比[OR]，2.95；95%CI，2.40-3.62；P<0.001）。无论试验臂如何，高依从性与降低产妇（OR，0.32；95%CI，0.11-0.93；P=0.04）和围产期（OR，0.64；95%CI，0.47-0.89；P=0.008）死亡率的几率相关。
在这项针对接受剖宫产手术的患者的阶梯式楔形集群随机临床试验中，未观察到手术部位感染率的显著降低。然而，围手术期标准的遵守情况在干预后得到了改善。
ClinicalTrials.gov 标识符：NCT04812522；泛非临床试验注册处标识符：PACT R202108717887402。
