剖宫产后的感染和并发症是埃塞俄比亚孕产妇死亡的重要原因。
■研究加强对围手术期标准的遵守和减少剖宫产术后并发症的计划的有效性。
■这项阶梯式楔形集群随机临床试验包括2021年8月24日至2023年1月31日在埃塞俄比亚9家医院进行剖宫产的患者,分为5个集群。
■干净切割,一个多模式手术质量改进计划,包括过程映射6个围手术期标准和创建特定部位,系统级改进。控制期是实施干预措施之前的时期。
■主要终点是手术部位感染率,次要终点是孕产妇死亡率和围产期死亡率以及感染和两种死亡率的复合结局.干预组和对照组均在术后30天进行评估,调整聚类和人口统计。还比较了两组之间对标准的遵守情况以及遵守情况与结果之间的关系。
■在9755名接受剖宫产的妇女中,在控制期间发生了5099例分娩(52.3%)(2722例紧急情况[53.4%]),在干预期间发生了4656例(47.7%)(2346例紧急情况[50.4%])。平均(SD)患者年龄为27.04(0.05)岁。5153例(52.8%)患者完成了30天的随访。干预后未发现感染率显着降低(OR,0.84;95%CI,0.55-1.27;P=.40)。术中感染预防标准在干预组和控制组显著提高,至少符合6项标准中的5项(比值比[OR],2.95;95%CI,2.40-3.62;P<.001)。不管审判手臂如何,高依从性与产妇几率降低相关(OR,0.32;95%CI,0.11-0.93;P=.04)和围产期(OR,0.64;95%CI,0.47-0.89;P=.008)死亡率。
■在这项针对剖宫产患者的阶梯式楔形整群随机临床试验中,未观察到手术部位感染的显著减少.然而,干预后,患者对围手术期标准的依从性得到改善.
■ClinicalTrials.gov标识符:NCT04812522;泛非临床试验注册标识符:PACTR202108717887402。
UNASSIGNED: Infections and complications following cesarean delivery are a significant source of maternal mortality in Ethiopia.
UNASSIGNED: To study the effectiveness of a program to strengthen compliance with perioperative standards and reduce postoperative complications following cesarean delivery.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT04812522; Pan-African Clinical Trials Registry Identifier: PACTR202108717887402.