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

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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.