Capacity for informed consent during labour

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Considering the background of physical and emotional stressors in labour, it is clear that there are ethical considerations in obtaining consent for research from women at this time. Although there is some literature on the validity of informed consent by women in labour, much of it is from an anaesthetics perspective only. Additionally, despite the availability of literature on women’s opinions of pregnancy and labour, there is a gap in knowledge about women’s ability to comprehend and retain information during labour. The proposed study focuses on addressing this gap and providing an evidence base regarding ethically obtaining consent, including research consent, in labour. Given the current paucity of evidence in this area, the study initially proposed is pilot in nature to ascertain the feasibility of a larger, comprehensive study and to confirm the utility of our proposed study methodology. The primary purpose of the study is to determine the capacity of pregnant women to comprehend (pregnancy and non-pregnancy related) and retain information during labour. This will be assessed, using healthy pregnant volunteers (pregnant women with no major pregnancy complications who are willing to undergo testing at approximately 36 weeks of pregnancy, in labour, and approximately 24 hours after the birth of their baby), through administration of standardised information and word lists, followed by testing of comprehension of the information and recall of the word lists. Participating women will be allocated to one of four groups: 1) Information given at both 35-37 weeks of pregnancy (at time of study enrolment) and during labour, information in written format 2) Information given at both 35-37 weeks of pregnancy (at time of study enrolment) and during labour, information in verbal (spoken) format 3) Information given only during labour, information in written format 4) Information given only during labour, information in verbal (spoken) format. Testing of immediate comprehension/recall will occur at enrolment at 35-37 weeks of pregnancy (if participant is allocated to one of the first 2 groups) and during labour (all participants). Testing of later recall (of information given during labour) will occur approximately 24 hours after the birth of the baby. The main study hypothesis is that the ability of women to comprehend and retain information will not be significantly affected by labour. Secondary aims of the study include comparing the efficacy of written versus verbal information format, and efficacy of provision of relevant information at approximately 36 weeks of pregnancy then again in labour versus information provision in labour only. The study will also consider the effect of other factors (e.g. epidural analgesia vs not, first baby or subsequent baby, woman's baseline behavioural state score) on information comprehension and recall.

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