Pregnant women’s views on informed consent for research in labour

Abstract

BackgroundStudies of the optimal treatment of accidental dural puncture occurring during epidural insertion in labour are difficult for practical reasons and because of the ethical issues around seeking consent. In a recent study of accidental dural puncture, participants were assigned to one of two treatment groups and only informed about the study and consent sought, after treatment. We sought the views of parturients on the timing of consent for such a study. MethodsAfter ethical approval and written consent, 100 nulliparous women in the third trimester of pregnancy completed a structured, facilitated questionnaire, rating the acceptability of the consent process occurring: (i) in antenatal clinic; (ii) after the epidural was requested in labour; (iii) after the accidental dural puncture had occurred but before treatment; (iv) after the allocated treatment; or (v) without consent (waived consent). Results were analysed with the Friedman and Wilcoxon signed-rank tests. ResultsAntenatal consent was considered the most acceptable option, whilst consent on request for epidural analgesia and after accidental dural puncture were least acceptable. Consent after treatment and waived consent were rated in-between these extremes. There was a statistically significant difference between these three groups (P<0.0001). There was a wide range of opinions on each option presented. ConclusionsAntenatal consent was the preferred option but if this is not possible and the need for the research is strong, consent for the use of women’s data after intervention, or waived consent, is acceptable to many women. It is important to seek the views of the participants themselves before planning research with difficult ethical aspects.