Abstract
Participation of pregnant women in clinical trials entails challenges mainly related to concerns about the risks for fetuses. We undertook a qualitative study from June to October 2020 to assess the acceptability of participating in COVID-19 clinical trials among pregnant women in Spain. Phenomenology and grounded theory were used as methodological approaches. Semi-structured interviews were conducted with 24 pregnant women and six healthcare providers. Women were unsure if pregnancy was a risk factor to acquire the infection or to develop severe disease and expressed the limited information they had received, which led to uncertainties and emotional suffering. They had concerns regarding participation in clinical trials on COVID-19, regardless of the drug under study. Healthcare providers alluded to the importance of involving pregnant women’s relatives at the recruitment visit of the clinical trial. These findings may be useful to facilitate pregnant women’s participation in clinical trials.
Highlights
IntroductionMore than half of pregnant women take drugs for the prevention or treatment of diseases, yet they are systematically excluded from clinical trials of medicinal products due to safety concerns, mostly related to potential harms to their fetuses [1,2,3]
We explored perceptions on the risks for SARS-CoV-2 infection and severity of COVID-19 disease, as well as barriers and facilitators to participate in a COVID-19 clinical trial among pregnant women and healthcare providers to help improve strategies for engagement of pregnant women in clinical trials
Women’s acceptability to participate in a COVID-19 clinical trial during pregnancy included different themes that emerged from the interviews conducted with pregnant women and healthcare workers, such as: knowledge and uncertainties about COVID-19 and pregnancy, perceptions of disease severity and vulnerability, pregnant women’s emotional state during the pandemic, and barriers and facilitators to trial participation
Summary
More than half of pregnant women take drugs for the prevention or treatment of diseases, yet they are systematically excluded from clinical trials of medicinal products due to safety concerns, mostly related to potential harms to their fetuses [1,2,3]. It is rare that new investigational products are designed and evaluated for their use during pregnancy [1], and the majority of therapeutic products prescribed during pregnancy have not been adequately studied for this purpose [4]. In recent health crises, such as the. Despite high maternal and perinatal mortality rates, pregnant women.
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