Abstract
BackgroundThe CORONIS Trial was a 2×2×2×2×2 non-regular, fractional, factorial trial of five pairs of alternative caesarean section surgical techniques on a range of short-term outcomes, the primary outcome being a composite of maternal death or infectious morbidity. The consequences of different surgical techniques on longer term outcomes have not been well assessed in previous studies. Such outcomes include those related to subsequent pregnancy: mode of delivery; abnormal placentation (e.g. accreta); postpartum hysterectomy, as well as longer term pelvic problems: pain, urinary problems, infertility. The Coronis Follow-up Study aims to measure and compare the incidence of these outcomes between the randomised groups at around three years after women participated in the CORONIS Trial.Methods/DesignThis study will assess the following null hypotheses: In women who underwent delivery by caesarean section, no differences will be detected with respect to a range of long-term outcomes when comparing the following five pairs of alternative surgical techniques evaluated in the CORONIS Trial:1. Blunt versus sharp abdominal entry2. Exteriorisation of the uterus for repair versus intra-abdominal repair3. Single versus double layer closure of the uterus4. Closure versus non-closure of the peritoneum (pelvic and parietal)5. Chromic catgut versus Polyglactin-910 for uterine repairThe outcomes will include (1) women’s health: pelvic pain; dysmenorrhoea; deep dyspareunia; urinary symptoms; laparoscopy; hysterectomy; tubal/ovarian surgery; abdominal hernias; bowel obstruction; infertility; death. (2) Outcomes of subsequent pregnancies: inter-pregnancy interval; pregnancy outcome; gestation at delivery; mode of delivery; pregnancy complications; surgery during or following delivery.DiscussionThe results of this follow-up study will have importance for all pregnant women and for health professionals who provide care for pregnant women. Although the results will have been collected in seven countries with limited health care resources (Argentina, Chile, Ghana, India, Kenya, Pakistan, Sudan) any differences in outcomes associated with different surgical techniques are likely to be generalisable throughout the world.Trial registrationISRCTN31089967
Highlights
The CORONIS Trial was a 2×2×2×2×2 non-regular, fractional, factorial trial of five pairs of alternative caesarean section surgical techniques on a range of short-term outcomes, the primary outcome being a composite of maternal death or infectious morbidity
Summary of existing evidence Existing systematic reviews of randomised controlled trials have been unable to draw clear conclusions about whether any of the techniques being compared in the CORONIS Trial are to be preferred [4,5,6,7,8,9]
Optimisation of surgical techniques may be able to reduce both the short-term and the long-term morbidity associated with caesarean section and differences may be relatively modest, the commonness of the operation means that even small improvements in outcome may result in substantial improvements in health for many thousands of women and considerable cost savings for health services
Summary
The CORONIS Trial was a 2×2×2×2×2 non-regular, fractional, factorial trial of five pairs of alternative caesarean section surgical techniques on a range of short-term outcomes, the primary outcome being a composite of maternal death or infectious morbidity. The consequences of different surgical techniques on longer term outcomes have not been well assessed in previous studies Such outcomes include those related to subsequent pregnancy: mode of delivery; abnormal placentation (e.g. accreta); postpartum hysterectomy, as well as longer term pelvic problems: pain, urinary problems, infertility. The trial is comparing (1) blunt versus sharp abdominal entry; (2) exteriorisation of the uterus for repair versus intra-abdominal repair; (3) single versus double layer closure of the uterus; (4) closure versus non-closure of the peritoneum (pelvic and parietal); (5) chromic catgut versus Polyglactin-910 for uterine repair, on a range of short-term outcomes, the primary outcome being a composite of maternal death or maternal infectious morbidity
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