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PAPERS: Tina Lavender, Carol Kingdon, Anna Hart, Gill Gyte, Mark Gabbay, and James P Neilson Could a randomised trial answer the controversy relating to elective caesarean section? National survey of consultant obstetricians and heads of midwifery BMJ 2005; 331: 490-491 [Full text]

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short-term outcomes, long-term questions

Sarah J Buckley   (9 September 2005)

Perhaps this question is better left unanswered

David J R Hutchon   (11 September 2005)

short-term outcomes, long-term questions 9 September 2005
Sarah J Buckley, GP, writer, mother Anstead, Qld , Australia 4070 Send response to journal: Re: short-term outcomes, long-term questions	The possibility, and desirability, of a randomised controlled trial (RCT) comparing vaginal with caesarean birth has been talked up in many parts of the world.1-3 Now Lavender and colleagues give us some reasons why it might, and might not, be feasible, and their study adds fuel to both sides of the debate.4 However, I suggest that we look further at the feasibility and impact of such a trial, and consider the lessons that have been learned by the Term Breech Trial (TBT), which similarly randomised mothers to vaginal or caesarean surgery.5 This trial, while perhaps avoiding some of the more ethically contentious elements of a ‘term cephalic trial’, because the pregnancies were high- rather than low-risk, reached an initial conclusion that caesarean surgery was safer. Virtually overnight, vaginal breech birth was lost as an option for women in countries rich enough to offer elective caesareans to healthy mothers. Four years later, the researchers published their follow-up of children at age 2, and found that the between-group differences had disappeared, and that vaginal breech birth was no more risky for offspring in the longer-term.6 The researchers concluded, in retrospect, that their trial was underpowered, and would have required follow-up of more than 4,000 children. The worldwide response to this update, and its impact on women carrying breech babies, has been negligible. The TBT experience highlights the importance of adequate sample size; avoiding premature conclusions; and long-term follow up; but the follow up should not finish with the young offspring. Every subsequent baby that is born to a woman with a prior caesarean is at increased risk, including risks of unexpected stillbirth,7 placenta praevia,8 placental abruption,8 and death from rupture of the mother’s uterus.9 The mother also has increased risks, in subsequent pregnancies, of all of the above, as well as ectopic pregnancy,10 placenta accreta and percreta,11 and postpartum hysterectomy for catastrophic bleeding.12 All of these can be expected to increase her risk of death. Such increased maternal mortality, in subsequent pregnancies, would only be ascertainable in a very large trial with extensive follow-up. However if, as with the TBT, the results of a smaller RCT lead to a change in practice such that many more women undergo elective caesareans, this small increase in maternal mortality will become significant in population terms. In effect, the original TBT study is becoming an ongoing, uncontrolled, and unrecorded trial of the entire population of breech mothers and babies, now subject to caesareans, with deaths of mothers in subsequent pregnancies being only documented anecdotally.13 Finally, in considering a randomised trial of vaginal birth vs caesarean surgery, we can consider our vestigial understanding of the sophisticated and finely-tuned psychoneuroendocrinology of labour and birth, and our ignorance of the longer-term implications of interference in this highly-evolved reproductive act.14 To my mind, there are many parallels between our current ignorance of the implications of depriving mother and baby of normal birth, and our recent ignorance of the implications of depriving mother and baby of breastfeeding. Until we know what we are really offering, and are prepared to offer extensive follow-up over decades, a ‘term cephalic trial’ may be as foolish as a RCT of breastfeeding vs formula feeding. References 1. Hannah ME. Planned elective cesarean section: a reasonable choice for some women? CMAJ 2004;170(5):813-4. 2. Robson S, Ellwood D. Should obstetricians support a 'term cephalic trial'? Aust N Z J Obstet Gynaecol 2003;43(5):341-3. 3. Ecker JL. Once a pregnancy, always a cesarean? Rationale and feasibility of a randomized controlled trial. Am J Obstet Gynecol 2004;190(2):314-8. 4. Lavender T, et al. Could a randomised trial answer the controversy relating to elective caesarean section? National survey of consultant obstetricians and heads of midwifery. BMJ 2005;331(7515):490-1. 5. Hannah ME, et al. Planned caesarean section versus planned vaginal birth for breech presentation at term: a randomised multicentre trial. Term Breech Trial Collaborative Group. Lancet 2000;356(9239):1375-83. 6. Whyte H, et al. Outcomes of children at 2 years after planned cesarean birth versus planned vaginal birth for breech presentation at term: the International Randomized Term Breech Trial. Am J Obstet Gynecol 2004;191(3):864-71. 7. Smith GC, et al. Caesarean section and risk of unexplained stillbirth in subsequent pregnancy. Lancet 2003;362(9398):1779-84. 8. Lydon-Rochelle M, et al. First-birth cesarean and placental abruption or previa at second birth(1). Obstet Gynecol 2001;97(5 Pt 1):765-9. 9. Guise JM, et al. Systematic review of the incidence and consequences of uterine rupture in women with previous caesarean section. BMJ 2004;329(7456):19-25. 10. Hemminki E, Merilainen J. Long-term effects of cesarean sections: ectopic pregnancies and placental problems. Am J Obstet Gynecol 1996;174(5):1569-74. 11. Chattopadhyay SK, et al. Placenta praevia and accreta after previous caesarean section. Eur J Obstet Gynecol Reprod Biol 1993;52(3):151-6. 12. Sheiner E, et al. Identifying risk factors for peripartum cesarean hysterectomy. A population-based study. J Reprod Med 2003;48(8):622-6. 13. Gaskin IM. The undervalued art of vaginal breech birth. Mothering July -August 2004;125:52-58. 14. Buckley SJ. Undisturbed Birth: Mother Nature's blueprint for safety, ease and ecstasy In:Gentle Birth, Gentle Mothering: The Best Articles on Gentle Choices in Pregnancy, Birth and Parenting.(In press)Brisbane, Australia:One Moon Press, 2005. Competing interests: I have had four home-born babies, including one breech birth.
Perhaps this question is better left unanswered 11 September 2005
David J R Hutchon, Locum Consultant Obstetricain Grey Base Hospital, Greymouth Send response to journal: Re: Perhaps this question is better left unanswered	Perhaps this question is better left unanswered There are more important questions to answer! Why as obstetricians are we prepared to shoot first and ask questions after? I am extremely grateful to Sarah Buckley as I had not appreciated that there was a further report on the term breech study. However as she points out the damage of the original report is already done and it will be very difficult to undo. If we don’t get the result we wish in a study, are we simply entitled to protest that the study was not powerful enough to show the results we expected? It is accepted in evidence based medicine that all novel approaches to management must be to study and analysis together with ongoing audit. Older established managements can also be revisited with the same approach. Artificial infant feeding and the liberal use of episiotomy are two approaches which were encouraged by some care workers without evidence of benefit. Fortunately the damage is being successfully reversed by movements such as the UNICEF UK Baby Friendly Initiative. Elective Caesarean section and immediate cord clamping have been adopted by many obstetricians without any evidence of benefit. Fortunately the Cochrane Collaboration now recommends that immediate cord clamping should not be carried out in preterm babies. Immediate cord clamping in the term infant is also an invasive intervention and more likely to be done at Caesarean Section. It requires evidence of benefit if it is to be continued. There are many theoretical reasons why immediate cord clamping could be responsible for a number of long term adverse diseases. It should be stopped immediately until such evidence is acquired. I also agree with Sarah Buckley that a RCT of elective Caesarean Section as a term cephalic trial would be, at this stage, quite futile. David Hutchon Consultant Obstetrician on sabbatical leave Competing interests: None declared