Department of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. box 85500, 3508 GA, Utrecht, the Netherlands.
Department of Obstetrics and Gynaecology, Academic Medical Center, Amsterdam, the Netherlands.
BMC Pregnancy Childbirth. 2019 Feb 11;19(1):65. doi: 10.1186/s12884-019-2209-7.
Bioethicists argue that inclusion of pregnant women in clinical research should be more routine to increase the evidence-base for pregnant women and foetuses. Yet, it is unknown whether pregnant women and others directly involved are willing to be routinely included. Therefore, we first need to establish what these stakeholders think about research participation in regular pregnancy-related research. However, studies on their views are scarce. In our study, we piggy-backed on a relatively conventional RCT, the APOSTEL VI study, to identify the views of stakeholders on inclusion of pregnant women in this study.
We conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed pregnant women (n = 14) recruited for the APOSTEL VI study, in addition to healthcare professionals (n = 14), Research Ethics Committee members (RECs) (n = 5) and regulators (n = 7) involved in clinical research in pregnant women.
Three themes characterise stakeholders' views on inclusion of pregnant women in the APOSTEL VI study. Additionally, one theme characterises stakeholders' interest in inclusion of pregnant women in clinical research in general. First, pregnant women participate in the APOSTEL VI study for potential individual benefit and secondarily for altruistic motives, contrary to hypothetical studies. Second, a gatekeeping tendency hampers recruitment of pregnant women who might be eligible and willing, and questions about pregnant women's decisional capacities surface. Third, healthcare professionals sometimes use the counselling conversation to steer pregnant women in a direction. Fourth, all stakeholders are hesitant about inclusion of pregnant women in clinical research in general due to a protective sentiment.
Pregnant women are willing to participate in the APOSTEL VI study for potential individual benefit and altruistic motives. However, an underlying protective sentiment, resulting in gatekeeping and directive counselling, sometimes hampers recruitment in the APOSTEL VI study as well as in clinical research in general. While bioethicists claim that inclusion of pregnant women should be customary, our study indicates that healthcare professionals, regulators, RECs and pregnant women themselves are not necessarily interested in inclusion. Advancing the situation and increasing the evidence-base for pregnant women and foetuses may require additional measures such as investing in the recruitment and feasibility of RCTs and stimulating pregnant women's decisional capacities.
生物伦理学家认为，应更常规地将孕妇纳入临床研究，以增加孕妇和胎儿的证据基础。然而，目前尚不清楚孕妇和其他直接相关人员是否愿意被常规纳入。因此，我们首先需要确定这些利益相关者对常规妊娠相关研究中的研究参与的看法。然而，关于这些观点的研究很少。在我们的研究中，我们利用一项相对常规的 RCT（APOSTEL VI 研究），来确定利益相关者对将孕妇纳入该研究的看法。
我们使用 35 次深度半结构式访谈和一次焦点小组进行了前瞻性定性研究。我们采访了参与 APOSTEL VI 研究的孕妇（n=14），以及医疗保健专业人员（n=14）、参与孕妇临床研究的研究伦理委员会成员（n=5）和监管机构（n=7）。
三个主题描述了利益相关者对将孕妇纳入 APOSTEL VI 研究的看法。此外，一个主题描述了利益相关者对将孕妇纳入一般临床研究的兴趣。首先，孕妇参与 APOSTEL VI 研究是为了潜在的个人利益，其次是出于利他主义动机，与假设性研究相反。其次，守门倾向阻碍了可能有资格和意愿的孕妇的招募，并引发了对孕妇决策能力的质疑。第三，医疗保健专业人员有时会在咨询对话中引导孕妇做出决定。第四，所有利益相关者都对一般临床研究中纳入孕妇持犹豫态度，因为存在保护情绪。
孕妇愿意参与 APOSTEL VI 研究，以获得潜在的个人利益和利他主义动机。然而，一种潜在的保护情绪，导致守门和指导咨询，有时会阻碍 APOSTEL VI 研究以及一般临床研究的招募。虽然生物伦理学家主张将孕妇纳入常规，但我们的研究表明，医疗保健专业人员、监管机构、研究伦理委员会成员和孕妇本身并不一定对纳入感兴趣。为了推进这一局面，增加孕妇和胎儿的证据基础，可能需要采取额外措施，如投资于 RCT 的招募和可行性，并激发孕妇的决策能力。
