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| ABSTRACT
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MRC |
UNIVERSITY OF KHARTOUM |
MATERNAL MORBIDITY AFTER CAESAREAN SECTION IN DEVELOPING COUNTRIES: LONG TERM FOLLOW-UP OF A LARGE FACTORIAL TRIAL |
EL SHEIKH, M |
KHARTOUM |
SUDAN |
View |
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 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 CORONIS trial will evaluate alternative techniques for the five most important aspects of the operation in a fractional factorial randomised controlled trial of 15,000 women: ?blunt? v. ?sharp? abdominal entry; extra-abdominal v. pelvic 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. The short-term primary outcome of the study is serious maternal morbidity. This follow-up study will allow us to assess long-term outcomes at 3 years after the original caesarean section to determine the impact of the different techniques on outcomes including: involuntary infertility and outcomes of subsequent pregnancies including uterine rupture. |
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MRC |
UNIVERSITY OF KHARTOUM |
PREVENTION OF MATERNAL MORBIDITY AFTER CAESAREAN SECTION IN DEVELOPING COUNTRIES: A FACTORIAL RCT OF SURGICAL METHODS |
EL SHEIKH, M |
KHARTOUM |
SUDAN |
View |
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.
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