CORONIS Long Term Follow-up

Maternal morbidity after caesarean section in developing countries: long term follow-up of a large factorial trial.

Trial started: 2011  Trial ended: 2015 

Summary

Objectives

To compare outcomes at 3 years following the different caesarean section surgical techniques evaluated in the CORONIS trial.

Methods

A follow-up of the international CORONIS randomised controlled trial conducted at 19 sites in Argentina, Chile, Ghana, India, Kenya, Pakistan and Sudan. Women undergoing their first or second caesarean section had been randomised to different combinations of surgical techniques: blunt versus sharp abdominal entry; exteriorisation of the uterus for repair versus intra-abdominal repair; single-layer versus double-layer closure of the uterus; closure versus non-closure of the peritoneum; and chromic catgut versus polyglactin-910 for uterine repair. In this follow-up study, outcomes were compared at 3 years.

Outcome measures

Outcomes: Pelvic pain, deep dyspareunia, hysterectomy and outcomes of subsequent pregnancies.

Results

Between 1 September 2011 and 30 September 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 risk ratio 0.66, 95% confidence interval 0.39 to 1.11) or in risk of death or serious morbidity of the children born at the time of trial entry (adjusted risk ratio 0.99, 95% confidence interval 0.83 to 1.17). For exteriorisation of the uterus versus intra-abdominal repair, there was no evidence of a difference in risk of infertility (adjusted risk ratio 0.91, 95% confidence interval 0.71 to 1.18) or ectopic pregnancy (adjusted risk ratio 0.50, 95% confidence interval 0.15 to 1.66). For single-layer versus double-layer uterine closure, there was no evidence of a difference in maternal death (adjusted risk ratio 0.78, 95% confidence interval 0.46 to 1.32) or a composite of pregnancy complications (adjusted risk ratio 1.20, 95% confidence interval 0.75 to 1.90). For closure versus non-closure of the peritoneum, there was no evidence of a difference in outcomes related to symptoms associated with pelvic adhesions, such as infertility (adjusted risk ratio 0.80, 95% confidence interval 0.61 to 1.06). For chromic catgut versus polyglactin-910 sutures, there was no evidence of a difference in the main comparisons for adverse outcomes in subsequent pregnancies, such as uterine rupture (adjusted risk ratio 3.05, 95% confidence interval 0.32 to 29.29). Overall, severe adverse outcomes were uncommon.

Conclusions

Although the study was not powered to detect modest differences in rare but serious events, there was no evidence to favour one surgical technique over another. Other considerations, such as the time and cost savings associated with different approaches, may therefore influence clinical practice.

Adapted from: Abalos E, Addo V, Brocklehurst P, et al. Caesarean section surgical techniques: 3 year follow-up of the CORONIS fractional, factorial, unmasked, randomised controlled trial. Lancet. 2016;388(10039):62–72. https://doi.org/10.1016/S0140-6736(16)00204-X. Licensed under the Creative Commons Attribution 4.0 International (CC BY 4.0) Licence (https://creativecommons.org/licenses/by/4.0/). Adapted for presentation on this website.