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，然而，尽管剖腹产的数量以及这种手术对妇女短期和长期健康的影响，我们对哪些剖腹产方法与最低的并发症风险相关知之甚少。这项研究将比较剖腹产时使用的外科手术的五个方面，看看这些方面中哪一个与并发症的风险最低有关。将进行比较的五对手术是：(A)两种不同的腹壁切开入路(钝器？(C)子宫上的伤口是用一层还是两层缝合(子宫的单层缝合还是双层缝合)；(D)腹膜是覆盖腹内所有器官的一层膜，使它们容易相互滑动，(关闭盆腔和顶层腹膜是否容易)；(E)两种不同类型的缝合材料中，哪一种应用于关闭子宫和部分腹壁(用于关闭子宫和直肌鞘的Vicryl缝合和肠线缝合)。这项研究的主要结果将是剖腹产手术后六周内感染。将从9个不同国家的12家医院招募1.5万名女性。

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.