The CORONIS Trial. International study of caesarean section surgical techniques: a randomised fractional, factorial trial

CORONIS Trial Collaborative Group, Edgardo Abalos, Victor Addo, J B Sharma, Jiji Matthews, James Oyieke, Shabeen Naz Masood, Mohamed A El Sheikh, CORONIS Trial Collaborative Group, Edgardo Abalos, Victor Addo, J B Sharma, Jiji Matthews, James Oyieke, Shabeen Naz Masood, Mohamed A El Sheikh

Abstract

Background: Caesarean section is one of the most commonly performed operations on women throughout the world. Rates have increased in recent years - about 20-25% in many developed countries. Rates in other parts of the world vary widely.A variety of surgical techniques for all elements of the caesarean section operation are in use. Many have not yet been rigorously evaluated in randomised controlled trials, and it is not known whether any are associated with better outcomes for women and babies. Because huge numbers of women undergo caesarean section, even small differences in post-operative morbidity rates between techniques could translate into improved health for substantial numbers of women, and significant cost savings.

Design: CORONIS is a multicentre, fractional, factorial randomised controlled trial and will be conducted in centres in Argentina, Ghana, India, Kenya, Pakistan and Sudan. Women are eligible if they are undergoing their first or second caesarean section through a transverse abdominal incision. Five comparisons will be carried out in one trial, using a 2 x 2 x 2 x 2 x 2 fractional factorial design. This design has rarely been used, but is appropriate for the evaluation of several procedures which will be used together in clinical practice. The interventions are:* 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 (pelvic and parietal)* Chromic catgut versus Polyglactin-910 for uterine repairThe primary outcome is death or maternal infectious morbidity (one or more of the following: antibiotic use for maternal febrile morbidity during postnatal hospital stay, antibiotic use for endometritis, wound infection or peritonitis) or further operative procedures; or blood transfusion. The sample size required is 15,000 women in total; at least 7,586 women in each comparison.

Discussion: Improvements in health from optimising caesarean section techniques are likely to be more significant in developing countries, because the rates of postoperative morbidity in these countries tend to be higher. More women could therefore benefit from improvements in techniques.

Trial registration: The CORONIS Trial is registered in the Current Controlled Trials registry. ISCRTN31089967.

References

    1. Menacker F, Curtin SC. Trends in cesarean birth and vaginal birth after previous cesarean, 1991-99. Natl Vital Stat Rep. 2001;49:1–16.
    1. Thomas J, Paranjothy S. The National Sentinel Caesarean Section Audit report. London: Royal College of Obstetricians and Gynaecologists; 2001.
    1. Belizan J, Althabe F, Barros F, Alexander S. Rates and implication of cesarean sections in Latin America: ecological study. BMJ. 1999;319:1397–1402.
    1. Sreevidya S, Sathiyasekaran BW. High caesarean rates in Madras (India): a population-based cross sectional study. BJOG. 2003;110:106–111. doi: 10.1046/j.1471-0528.2003.02006.x.
    1. Tully L, Gates S, Brocklehurst P, Ayers S, McKenzie-McHarg K. Surgical techniques used in caesarean section operations in the UK: a survey of current practice. Eur J Obstet Gynecol Reprod Biol. 2002;102:120–126. doi: 10.1016/S0301-2115(01)00589-9.
    1. Mathai M, Hofmeyr GJ. Abdominal surgical incisions for caesarean section. Cochrane Database Syst Rev. 2003. p. CD004453.
    1. Decavalas G, Papadopoulos V, Tzingounis V. A prospective comparison of surgical procedures in caesarean section. Acta Obstet Gynecol Scand. 1997;76:30.
    1. Mathai M, Ambersheth S, George A. Comparison of two transverse abdominal incisions for cesarean delivery. Int J Gynaecol Obstet. 2002;78:47–49. doi: 10.1016/S0020-7292(02)00061-9.
    1. Franchi M, Ghezzi F, Raio L, Di Naro E, Miglierina M, Agosti M, Bolis P. Joel-Cohen or Pfannenstiel incision at cesarean delivery: does it make a difference? Acta Obstet Gynecol Scand. 2002;81:1040–1046. doi: 10.1034/j.1600-0412.2002.811108.x.
    1. Hofmeyr GJ, Mathai M. Techniques for caesarean section. Cochrane Database Syst Rev. 2004. p. CD0004662.
    1. Jacobs-Jokhan D, Hofmeyr GJ. Extra-abdominal versus intra-abdominal repair of the uterine incision at caesarean section. Cochrane Database Syst Rev. 2004:CD000085.
    1. Edi Osagie EC, Hopkins RE, Ogbo V, et al. Uterine exteriorisation at caesarean section: influence on maternal morbidity. Br J Obstet Gynaecol. 1998;105:1070–1078.
    1. Bamigboye AA, Hofmeyr GJ. Closure versus non-closure of the peritoneum at caesarean section. Cochrane Database Syst Rev. 2003:CD000163.
    1. Roset E, Boulvain M, Irion O. Nonclosure of the peritoneum during caesarean section: long-term follow-up of a randomised controlled trial. Eur J Obstet Gynecol Reprod Biol. 2003;108:40–44. doi: 10.1016/S0301-2115(02)00366-4.
    1. Enkin MW, Wilkinson C. Single versus two layer suturing for closing the uterine incision at caesarean section. Cochrane Database Syst Rev. 2000:CD000192.
    1. Dodd JM, Anderson ER, Gates S. Surgical techniques involving the uterus at the time of caesarean section. Cochrane Database Syst Rev. 2004. p. CD004732.
    1. Heidenreich W, Bruggenjurgen K. [Modified Sarafoff suture for single layer closure of uterotomy in cesarean section. A prospective study] Zentralbl Gynakol. 1995;117:40–44. [Article in German]
    1. Sood AK. Single versus double layer of low transverse uterine incision at cesarean section. J Obstet Gynecol India. 2005;55:231–236.
    1. Chapman SJ, Owen J, Hauth JC. One- versus two-layer closure of a low transverse cesarean: the next pregnancy. Obstet Gynecol. 1997;89:16–18. doi: 10.1016/S0029-7844(97)84257-3.
    1. Bujold E, Bujold C, Hamilton EF, Harel F, Gauthier RJ. The impact of a single-layer or double-layer closure on uterine rupture. Am J Obstet Gynecol. 2002;186:1326–30. doi: 10.1067/mob.2002.122416.
    1. Durnwald C, Mercer B. Uterine rupture, perioperative and perinatal morbidity after single-layer and double-layer closure at cesarean delivery. Am J Obstet Gynecol. 2003;189:925–929. doi: 10.1067/S0002-9378(03)01056-1.
    1. Anderson ER, Gates S. Techniques and materials for closure of the abdominal wall in caesarean section. Cochrane Database Syst Rev. 2004:CD004663.
    1. Hauth JC, Owen J, Davis RO. Transverse uterine incision closure: one versus two layers. Am J Obstet Gynecol. 1992;167:1108–1111.
    1. ISIS-4 Pilot Study Investigators Randomised controlled trial of oral captopril, of oral isosorbide mononitrate and of intravenous magnesium sulphate started early in acute myocardial infarction: safety and haemodynamic effects. Eur Heart J. 1994;15:608–619.
    1. Grampian Asthma Study of Integrated Care (GRASSIC) Integrated care for asthma: a clinical, social and economic evaluation. BMJ. 1994;308:559–564.
    1. DAMOCLES Study Group NHS Health Technology Assessment Programme. A proposed charter for clinical trial data monitoring committees: helping them to do their job well. Lancet. 2005;365:711–722.
    1. Peto R, Pike MC, Armitage P, et al. Design and analysis of randomised clinical trials requiring prolonged observation of each patient. 1. Introduction and design. Br J Cancer. 1976;34:585–612.

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel