ABSTRACT
Objectives: Excluding pregnant persons from COVID-19 trials of intervention may lead to unintended harmful consequences. Beliefs and attitudes of clinicians have the potential to shape clinical research involving pregnant women. This study evaluates the current perspectives of Canadian physicians on the participation of pregnant women in COVID-19 clinical trials. Methods: An anonymous 22-item online questionnaire was sent to Canadian physicians belonging to four Canadian professional associations. Physicians were surveyed regarding the inclusion of pregnant women in COVID-19 trials using a semi-quantitative approach with multiple choice and open-ended questions. Descriptive statistics were performed. Themes from free-text answers were extracted using a semi-inductive approach. Results: 202 physicians agreed to participate, 168 of which completed the survey. 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%). In addition, 66% (107/161) of physicians responded that including pregnant women in COVID-19 trials was urgent. The main barriers to including pregnant women in COVID-19 trials were perceived unwillingness of pregnant patients to take part in clinical trials, perceived unwillingness of treating teams to offer participation, burden of regulatory approval, and a general ‘culture of exclusion’ of pregnant women from clinical trials. Conclusions: Most physicians surveyed were supportive of the inclusion of pregnant women in COVID-19 trials of intervention. Importantly, we describe why some physicians may be reluctant to include pregnant women in clinical trials and identify important barriers to be addressed for the appropriate participation of pregnant women in clinical research.