Prevention of maternal morbidity after caesarean section in developing countries: a factorial RCT of surgical methods

剖腹产是世界上最常见的手术之一，尽管剖腹产的数量和这种手术对妇女短期和长期健康的影响，我们对剖腹产的方法知之甚少。这项研究将比较剖腹产手术时使用的五个方面，看看这些方面中的哪一个与并发症风险最低相关。比较的五对手术是：（a）两种不同的腹壁开放方法（？钝的？对比？sharp？）; (b)子宫上的伤口是在子宫保留在女性骨盆内时修复，还是在骨盆外修复，（子宫切口的腹外修补与腹内修补）;（c）子宫切口是缝合一层还是两层（子宫单层闭合与双层闭合）;（四）腹膜是一层薄薄的膜，覆盖腹部内所有器官，让它们容易互相滑动，（盆腔和壁层腹膜闭合与不闭合）;（e）封闭子宫及部分腹壁时，应使用两种不同的缝合材料中的哪一种（薇乔缝线与羊肠线缝合子宫和腹直肌鞘）。研究的主要结果将是剖腹产手术后6周内的感染。将从9个不同国家的12家医院招募15 000名妇女。

Caesarean section is one of the commonest operations undertaken worldwide and yet despite the number of caesarean sections being performed and the impact of this operation on the short and long term health of women, we know very little about which approaches to doing the caesarean section are associated with the lowest risk of complications. This study will compare five aspects of the surgical procedures used at the time of caesarean section to see which of these aspects is associated with the lowest risk of complications. The five pairs of procedures to be compared are: (a) two different approaches to opening the abdominal wall (?blunt? versus ?sharp?); (b) whether the cut on the womb is repaired while the womb is kept inside the womans pelvis or whether it is repaired outside (extra-abdominal versus intra-abdominal repair of the uterine incision); (c) whether the cut on the womb is closed in one layer of stitches or two (single versus double layer closure of the uterus); (d) whether the peritoneum, which is a thin membrane which covers all the organs inside the abdomen, letting them slide over each other easily, (closure versus non-closure of the pelvic and parietal peritoneum); (e) which of two different types of stitch material should be used for closing the womb and part of the abdominal wall (Vicryl versus catgut sutures for closure of the uterus and rectus sheath).The main outcome of the study will be infection in the six weeks following the caesarean section operation. 15,000 women will be recruited from 12 hospitals in 9 different countries.