• M M L H Wassen, L J M Smits, H C J Scheepers, M A E Marcus, J Van Neer, J G Nijhuis, and F J M E Roumen.
• Department of Obstetrics and Gynaecology, Maastricht University Medical Centre+, GROW - School for Oncology and Developmental Biology, Maastricht, The Netherlands.
• BJOG. 2015 Feb 1;122(3):344-50.

ObjectiveTo assess the effect on mode of delivery of the routine use of labour epidural analgesia (EA) compared with analgesia on request.DesignRandomised non-inferiority trial.SettingOne university and one non-university teaching hospital in The Netherlands.PopulationWomen with a singleton pregnancy in cephalic presentation beyond 36 + 0 weeks' gestation.MethodsParticipants were randomly allocated to receive either routine EA or analgesia on request. Intention-to-treat (ITT) and per-protocol (PP) analyses were performed, with confidence intervals (CI) calculated for the differences in percentages or means.Main Outcome MeasuresRate of operative delivery (instrumental vaginal or caesarean), labour characteristics, and adverse labour and neonatal outcomes.ResultsA total of 488 women were randomly allocated to the routine EA (n = 233) or analgesia on request group (n = 255). In the routine EA group, 89.3% (208/233) received EA. According to ITT analysis, 34.8% (81/233) women in the routine EA group had an operative delivery, compared with 26.7% (68/255) in the analgesia on request group (difference 8.1%, 95% CI -0.1 to 16.3). The difference in rate of operative deliveries according to the PP analysis was statistically significant (difference 8.9%, 95% CI 0.4 to 17.4). Inferiority of EA could not be rejected, as in both analyses the upper bound of the confidence interval exceeded the pre-specified inferiority criterion of +10%. Women in the routine EA group had more adverse effects, including hypotension (difference 9.5%, 95% CI 4.2 to 14.9), and motor blockade (difference 6.8%, 95% CI 1.1 to 12.5).ConclusionNon-inferiority of routine EA could not be demonstrated in this trial. Routine EA use is likely to lead to more operative deliveries and more maternal adverse effects. The results of our study do not justify routine use of EA.© 2014 Royal College of Obstetricians and Gynaecologists.

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