SummaryBackground Variations exist in the surgical techniques used for caesarean section and many have not been rigorously assessed in randomised controlled trials. We aimed to assess whether any surgical techniques were associated with improved outcomes for women and babies.Methods CORONIS was a pragmatic international 2×2×2×2×2 non-regular fractional, factorial, unmasked, randomised controlled trial that examined fi ve elements of the caesarean section technique in intervention pairs. CORONIS was undertaken at 19 sites in Argentina, Chile, Ghana, India, Kenya, Pakistan, and Sudan. Each site was assigned to three of the fi ve intervention pairs: blunt versus sharp abdominal entry; exteriorisation of the uterus for repair versus intraabdominal repair; single-layer versus double-layer closure of the uterus; closure versus non-closure of the peritoneum (pelvic and parietal); and chromic catgut versus polyglactin-910 for uterine repair. Pregnant women were eligible if they were to undergo their fi rst or second caesarean section through a planned transverse abdominal incision. Women were randomly assigned by a secure web-based number allocation system to one intervention from each of the three assigned pairs. All investigators, surgeons, and participants were unmasked to treatment allocation. The primary outcome was the composite of death, maternal infectious morbidity, further operative procedures, or blood transfusion (>1 unit) up to the 6-week follow-up visit. Women were analysed in the groups into which they were allocated. The CORONIS Trial is registered with Current Controlled Trials: ISRCTN31089967. Interpretation These fi ndings suggest that any of these surgical techniques is acceptable. However, longer-term follow-up is needed to assess whether the absence of evidence of short-term eff ects will translate into an absence of long-term eff ects.Funding UK Medical Research Council and WHO.

SummaryBackgroundThe CORONIS trial reported differences in short-term maternal morbidity when comparing five pairs of alternative surgical techniques for caesarean section. Here we report outcomes at 3 years follow-up.MethodsThe CORONIS trial was a pragmatic international 2 × 2 × 2 × 2× 2 non-regular fractional, factorial, unmasked, randomised controlled trial done at 19 sites in Argentina, Chile, Ghana, India, Kenya, Pakistan, and Sudan. Pregnant women were eligible if they were to undergo their first or second caesarean section through a planned transverse abdominal incision. Women were randomly assigned by a secure web-based allocation system to one intervention from each of the three assigned pairs. All investigators, surgeons, and participants were unmasked to treatment allocation. In this follow-up study, we compared outcomes at 3 years following blunt versus sharp abdominal entry, exteriorisation of the uterus for repair versus intra-abdominal repair, single versus double layer closure of the uterus, closure versus non-closure of the peritoneum, and chromic catgut versus polyglactin-910 for uterine repair. Outcomes included pelvic pain; deep dyspareunia; hysterectomy and outcomes of subsequent pregnancies. Outcomes were assessed masked to the original trial allocation. This trial is registered with the Current Controlled Trials registry, number ISRCTN31089967.FindingsBetween Sept 1, 2011, and Sept 30, 2014, 13 153 (84%) women were followed-up for a mean duration of 3·8 years (SD 0·86). For blunt versus sharp abdominal entry there was no evidence of a difference in risk of abdominal hernias (adjusted RR 0·66; 95% CI 0·39–1·11). We also recorded no evidence of a difference in risk of death or serious morbidity of the children born at the time of trial entry (0·99, 0·83–1·17). For exteriorisation of the uterus versus intra-abdominal repair there was no evidence of a difference in risk of infertility (0·91, 0·71–1·18) or of ectopic pregnancy (0·50, 0·15–1·66). For single versus double layer closure of the uterus there was no evidence of a difference in maternal death (0·78, 0·46–1·32) or a composite of pregnancy complications (1·20, 0·75–1·90). For closure versus non-closure of the peritoneum there was no evidence of a difference in any outcomes relating to symptoms associated with pelvic adhesions such as infertility (0·80, 0·61–1·06). For chromic catgut versus polyglactin-910 sutures there was no evidence of a difference in the main comparisons for adverse pregnancy outcomes in a subsequent pregnancy, such as uterine rupture (3·05, 0·32–29·29). Overall, severe adverse outcomes were uncommon in these settings.InterpretationAlthough our study was not powered to detect modest differences in rare but serious events, there was no evidence to favour one technique over another. Other considerations will probably affect clinical practice, such as the time and cost saving of different approaches.FundingUK Medical Research Council and the Department for International Development.

Provenance Commissioned, externally peer reviewed. Competing interests Keri Thomas is clinical lead and employee of the GSF Centre in End of Life Care, a not-for-profit voluntary-sector Community Interest Company, which emerged from the NHS in 2010, dedicated to improving end-of-life care in all settings.

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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