BJOG. 2010 Oct;117(11):1366-76. doi: 10.1111/j.1471-0528.2010.02686.x.
In women undergoing delivery by caesarean section, do the following alternative surgical techniques affect the risk of adverse outcomes: single- versus double-layer closure of the uterine incision; closure versus nonclosure of the pelvic peritoneum; liberal versus restricted use of a subrectus sheath drain?
Pragmatic, 2 × 2 × 2 factorial randomised controlled trial.
Hospitals in the UK and Italy providing intrapartum care.
Women undergoing their first caesarean section.
The interventions were alternative approaches to the three aspects of the caesarean section operation. A telephone randomisation service was used. Surgeons could not be masked to allocation, but women were unaware of which allocations had been used. The analysis was by intention-to-treat, with a prespecified subgroup analysis for women 'in labour' or 'not in labour' at the time of caesarean section.
Maternal infectious morbidity.
A total of 3033 women were recruited. Overall, the risk of maternal infectious morbidity was 17%. For each pair of interventions, there were no differences between the arms of the trial for the primary outcome: single- versus double-layer closure of the uterine incision [relative risk (RR) = 1.00, 95% confidence interval (95% CI) = 0.85-1.18]; closure versus nonclosure of the pelvic peritoneum (RR = 0.92, 95% CI = 0.78-1.08); liberal versus restricted use of a subrectus sheath drain (RR = 0.92, 95% CI = 0.78-1.09). There were no differences in any of the secondary morbidity outcomes and no significant adverse effects of any of the techniques used.
These results have implications for clinical practice, particularly in relation to current guidance on the closure of the peritoneum, which suggests that nonclosure is preferable. The potential effects of these different surgical techniques on longer term outcomes, including the functional integrity of the uterine scar during subsequent pregnancies, are now becoming increasingly important for guiding clinical practice.
在接受剖宫产的女性中，以下替代手术技术是否会影响不良结局的风险：子宫切口的单层与双层缝合；缝合与不缝合盆腹膜；使用或不使用耻骨后鞘引流管？
实用的 2×2×2 析因随机对照试验。
英国和意大利的提供分娩期护理的医院。
首次接受剖宫产的女性。
干预措施是剖宫产手术三个方面的替代方法。使用电话随机分配服务。外科医生无法对分配情况进行掩盖，但女性不知道使用了哪些分配情况。分析采用意向治疗，对剖宫产时“在产程中”或“不在产程中”的女性进行了预设亚组分析。
产妇感染性发病率。
共纳入 3033 名女性。总体而言，产妇感染性发病率为 17%。对于每一对干预措施，试验组之间的主要结局均无差异：子宫切口的单层与双层缝合[相对风险（RR）=1.00，95%置信区间（95%CI）=0.85-1.18]；缝合与不缝合盆腹膜（RR=0.92，95%CI=0.78-1.08）；使用或不使用耻骨后鞘引流管（RR=0.92，95%CI=0.78-1.09）。任何次要发病率结局均无差异，任何使用的技术均无明显不良影响。
这些结果对临床实践具有重要意义，特别是与当前关于腹膜闭合的指南有关，该指南表明不缝合腹膜更为可取。这些不同手术技术对长期结局的潜在影响，包括在随后的妊娠中子宫疤痕的功能完整性，现在对于指导临床实践变得越来越重要。
