Friday, January 16, 2009

Support for a cesarean/vaginal delivery comparative trial?

Australian Researchers Catherine Turner et al have recently published 'Willingness of pregnant women and clinicians to participate in a hypothetical randomised controlled trial comparing vaginal delivery and elective caesarean section', in which they conclude that a "randomised controlled trial comparing vaginal delivery and elective caesarean section may not be feasible due to low levels of willingness to participate, particularly among pregnant women."

This type of comparative trial has been criticized for being unethical and/or unfeasible in the past (by other researchers and doctors), but this latest research from Australia isn't all negative. The authors begin by stating that "Elective caesarean section is controversial in the absence of compelling evidence of the relative benefits and harms compared with vaginal delivery. A randomised trial of the two procedures to compare outcomes for women and babies would provide the best quality scientific evidence to confirm this debate but it is not known whether such a trial would be feasible."

They set out to ascertain what proportion of pregnant women and clinicians would participate in a hypothetical randomised controlled trial comparing the two delivery methods by asking pregnant women (via interviews) and midwives, obstetricians, urogynaecologists and colorectal surgeons (via a mailed, self-administered questionnaire).

How many support a hypothetical trial?
Out of 100 pregnant women, 84 midwives, 166 obstetricians, 12 urogynaecologists and 87 colorectal surgeons, 14% of pregnant women and 31% of clinicians indicated that they would participate in a randomised controlled trial.

Is this enough?
14% is a very low number, but I would be interested to learn whether the 100 women questioned already had a birth plan in mind, and also whether the hypothetical trial (as explained to them) meant that they would get to choose between each delivery or whether that delivery method would be allocated to them. These factors are crucial and could make a huge difference to the final percentage tally.

31% is almost a third of clinicians saying 'yes', and this is actually a sizeable proportion. If nothing else, it indicates that aversion to such a trial is no longer in the minority.

Trial alternatives?
The number of healthy women electing to have cesarean deliveries with no medical indication is reportedly low. However, these women do exist and their health outcome data is on record at hospitals (especially private hospitals) throughout the world. If we could gather the data available for some or all of these deliveries, this would go a long way to informing risk and benefit analysis as compared to planned vaginal deliveries in healthy women (the data of which is readily available at numerous large hospitals).

Trial fears?
In 2003, doctors in Australia asked the question 'Should obstetricians support a 'term cephalic trial'? (Robson S, Ellwood D. Aust N Z J Obstet Gynaecol. 2003 Oct;43(5):341-3.) In subsequent media reports, they were quoted as saying:

Dr Robson: 'What a disaster it would be if it was found elective cesarean was safer than vaginal birth.'
Dr Ellwood: 'There is an increasing trend towards elective cesareans, and there have been discussions over the last couple of years about mounting the so-called term-cephalic trial, which would be a randomised trial comparing cesarean versus planned vaginal birth for women having their first babies. We're concerned that the impact of such a trial could well be quite far reaching, and that it needs to be well thought through before such a trial is mounted.' [The reporter continued:] His fear is that if caesarean sections were found to be safer in such a trial, doctors and patients might feel compelled to go that way.

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