Quattrini Eva, Ireland Demelza J, Keelan Jeffrey A
School of Biomedical Sciences, University of Western Australia, Perth, Western Australia, Australia.
Aust N Z J Obstet Gynaecol. 2025 Apr;65(2):218-226. doi: 10.1111/ajo.13884. Epub 2024 Sep 27.
Pregnant women have historically been excluded from participation in medication trials, in part due to the perceived risks of drug exposure to mothers and fetuses. However, little is known about pregnant women's attitudes toward risk and participation in such trials.
To address this knowledge gap and to identify factors that influence trial participation.
Australian women over the age of 18, currently pregnant or within six months of delivery, were recruited to participate in an online survey (n = 623) and follow-up interviews (n = 11). The survey investigated willingness to participate in five hypothetical drug trial scenarios of varying risk. Demographic and obstetric information, including COVID-19 vaccination status, was also collected. The impact of these factors on trial participation was analysed using ordinal regression. Interviews were subjected to thematic framework analysis using a priori and emergent themes.
Nearly half of the respondents (48%) indicated a willingness to participate in at least one of the hypothetical trials. As trial risk increased participation likelihood decreased, especially if the risk was to the fetus, regardless of benefits to the mother. COVID-19 vaccination status and medication hesitancy were predictors of an unwillingness to participate. Three broad themes emerged from the qualitative data: risk-benefit analysis, quality of evidence, and trust.
Overall, participants expressed a positive attitude toward research and medication trials during pregnancy, but were concerned about fetal risk. The findings of this study may help enhance trial design and the participation of pregnant women in medication trials.
历史上孕妇一直被排除在药物试验参与之外，部分原因是人们认为药物暴露会对母亲和胎儿造成风险。然而，对于孕妇对风险的态度以及参与此类试验的情况知之甚少。
填补这一知识空白，并确定影响试验参与的因素。
招募年龄在18岁以上、目前怀孕或在分娩后六个月内的澳大利亚女性参与在线调查（n = 623）和后续访谈（n = 11）。该调查研究了参与五种不同风险的假设药物试验场景的意愿。还收集了人口统计学和产科信息，包括新冠疫苗接种状况。使用有序回归分析这些因素对试验参与的影响。访谈采用先验主题和新出现主题进行主题框架分析。
近一半的受访者（48%）表示愿意参与至少一种假设试验。随着试验风险增加，参与可能性降低，尤其是当风险涉及胎儿时，无论对母亲有无益处。新冠疫苗接种状况和用药犹豫是不愿意参与的预测因素。定性数据中出现了三个广泛的主题：风险效益分析、证据质量和信任。
总体而言，参与者对孕期研究和药物试验表达了积极态度，但担心胎儿风险。本研究结果可能有助于改进试验设计以及孕妇参与药物试验的情况。
