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

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.

Caesarean section is one of the most common operations in the world, yet the techniques used to perform it have not been adequately evaluated in randomised controlled trials. Operative techniques vary widely between surgeons, and the frequency of the operation means than even small improvements in outcome may allow substantial improvements in the health of mothers, particularly in developing countries, where post-operative morbidity is high. The International CAESAR study aims to evaluate alternative techniques for the five most important aspects of the operation in a large pragmatic randomised controlled trial: ?blunt? v. ?sharp? abdominal entry; extra-abdominal v. intra-abdominal repair of the uterine incision; single v. double layer closure of the uterus; closure v. non-closure of the pelvic and parietal peritoneum; chromic catgut v. Vicryl for closure of the uterus and rectus sheath.

Women are eligible if they are undergoing a lower segment caesarean section, and if no specific surgical technique is indicated.

The primary outcome of the study is serious maternal morbidity. Short term secondary outcomes such as endometritis, wound infection, pain and maternal mortality will also be measured. The trial sample size is 14,904 women recruited over three years from at least 12 hospitals in seven developing countries.