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. 2021 Nov;43(6):19-27.
doi: 10.1002/eahr.500107. Epub 2021 Oct 26.

Physician Perspectives on Including Pregnant Women in Covid-19 Clinical Trials: Time for a Paradigm Change

Marie-Julie Trahan  1 , Annabelle Cumyn  2 , Matthew P Cheng  3 , Emily G McDonald  4 , Stephen E Lapinsky  5 , Nick Daneman  6 , Haim A Abenhaim  7 , Isabelle Malhamé  8
Affiliations

Physician Perspectives on Including Pregnant Women in Covid-19 Clinical Trials: Time for a Paradigm Change

Marie-Julie Trahan et al. Ethics Hum Res. 2021 Nov.

Abstract

Excluding pregnant people from Covid-19 clinical trials may lead to unintended harmful consequences. For this study, an online questionnaire was sent to physicians belonging to Canadian professional medical associations in order to evaluate their perspectives on the participation of pregnant women in Covid-19 clinical trials. The majority of respondents expressed support for including pregnant women in Covid-19 trials (119/165; 72%), especially those investigating therapies with a prior safety record in pregnancy (139/164; 85%). The main perceived barriers to inclusion identified were unwillingness of pregnant patients to participate and of treating teams to offer participation, the burden of regulatory approval, and a general "culture of exclusion" of pregnant women from trials. We describe why some physicians may be reluctant to include pregnant individuals in trials, and we identify barriers to the appropriate participation of pregnant people in clinical research.

Keywords: Covid-19 clinical trials; human subjects research; inclusion of pregnant women in trials; maternal-fetal ethics; pregnant research participants; research with pregnant women.

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Figures

Figure 1
Figure 1
Perspectives and Opinions regarding the Inclusion of Pregnant Women in Covid‐19 Trials
See this image and copyright information in PMC

References

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