Ayling Laura, Henry Amanda, Tracy Sally, Donkin Chris, Kasparian Nadine A, Welsh Alec W
School of Women's and Children's Health, UNSW Medicine, The University of New South Wales , Kensington , New South Wales , Australia.
Department of Maternal-Fetal Medicine, Royal Hospital for Women , Randwick , New South Wales , Australia.
J Obstet Gynaecol. 2019 Oct;39(7):913-921. doi: 10.1080/01443615.2019.1575341. Epub 2019 May 8.
Medical informed consent is the process by which a 'competent', non-coerced individual receives sufficient information including risks of a medical procedure and gives permission for it to occur. The capacity to give an informed consent might be impaired during labour. This study aimed to examine women's abilities to understand and remember during labour. Women were prospectively recruited at 36 weeks of gestation and randomised to undertake questionnaires which assessed their ability to understand and remember information. They were randomised to: (1) information given in labour only, written format (2) information in labour, verbal (3) information at 36 weeks plus labour, written (4) information at 36 weeks plus labour, verbal. Immediate comprehension and retention was assessed at 36 weeks, in labour, and 24-72 hours after birth. Forty-nine women completed the questionnaires regarding understanding and retention of information at 36 weeks, six intrapartum, and five postpartum (90% attrition). Women receiving information at 36 weeks and in labour in labour had a higher comprehension of pregnancy-related information, its retention, and total score. Women receiving information in late pregnancy and labour may comprehend and retain it better than women only receiving information during labour. Given small sample size, further research is needed to support these preliminary findings. Impact statement The evidence regarding the capacity of labouring women to give informed consent is largely based on women's self-reported experiences or expert opinions and has mixed findings. Existing guidelines recommend that an informed consent should be given antenatally for both clinical practice and research. Studies show that obtaining an informed consent antenatally is neither feasible nor widely implemented. A novel approach to providing empirical evidence regarding women's capacity to comprehend and retain information during labour. Our study confirms the difficulty with antenatal recruitment for intrapartum research. This raises ethical concerns regarding the current intrapartum research in which consent is largely sought at the time of the study. Emphasises the need to explore the question 'Do labouring women have the capacity to consent to research?' in order to ensure that women are protected during labour.
医疗知情同意是一个过程，在此过程中，“有行为能力的”、未受胁迫的个体获得足够的信息，包括医疗程序的风险，并允许该程序进行。在分娩过程中，给予知情同意的能力可能会受到损害。本研究旨在考察女性在分娩过程中的理解和记忆能力。在妊娠36周时前瞻性招募女性，并随机分组让她们接受评估其理解和记忆信息能力的问卷调查。她们被随机分为：（1）仅在分娩时以书面形式提供信息；（2）在分娩时以口头形式提供信息；（3）在36周加分娩时以书面形式提供信息；（4）在36周加分娩时以口头形式提供信息。在36周、分娩时以及产后24 - 72小时评估即时理解和记忆情况。49名女性完成了关于在36周时对信息的理解和记忆的问卷，6名女性在产时完成，5名女性在产后完成（损耗率90%）。在36周和分娩时都收到信息的女性对与妊娠相关信息的理解、记忆以及总分更高。在妊娠晚期和分娩时收到信息的女性可能比仅在分娩时收到信息的女性理解和记忆得更好。鉴于样本量小，需要进一步的研究来支持这些初步发现。影响声明 关于分娩女性给予知情同意能力的证据主要基于女性的自我报告经历或专家意见，且结果不一。现有指南建议，对于临床实践和研究，均应在产前给予知情同意。研究表明，在产前获得知情同意既不可行也未广泛实施。一种提供关于女性在分娩过程中理解和记忆信息能力的实证证据的新方法。我们的研究证实了为产时研究进行产前招募的困难。这引发了对当前产时研究的伦理关注，在当前产时研究中，同意大多在研究时寻求。强调需要探讨“分娩女性有能力同意参与研究吗？”这一问题，以确保女性在分娩过程中得到保护。
