Midwives’ attitudes toward participation of pregnant women in a preventive vaccine hypothetical clinical trial

Introduction Pregnant women are frequently excluded from clinical trials. Yet, inclusion of pregnant women is of interest in vaccinology including during health crisis. Promotion of clinical trials by midwives may facilitate the decision making of pregnant women. Attitudes of midwives about participation in a vaccine clinical trial have been little explored. Methods We conducted an anonymous survey from the 11th of September to the 11th of November 2020. Primary endpoint was the willingness to encourage pregnant women to participate in a hypothetical respiratory syncytial virus (RSV) vaccine clinical trial. Results Among 398 midwives who answered the questionnaire, 113 (28.3 %) were likely to encourage pregnant women to participate in the vaccine clinical trial, this proportion ranged from 25 % in senior midwives to 34.5 % among the students. After adjustment on age, parenthood, previous vaccine hesitancy attitudes, and the 5 components of the 5C model, the only predictor of the promotion of the clinical trial was the training score with an adjusted odds ratio of 1.09 (1.01-1.18, p=0.027) for a one-point increase. Vaccine hesitancy and psychological antecedents of vaccinations were not associated with a lower promotion of pregnant women trial participation among midwives. Conclusion Few respondents were likely to encourage pregnant women to participate in a vaccine clinical trial. Midwives who considered having a good training about vaccines were more prone to encourage pregnant women to participate in a RSV vaccine clinical trial. Problem or Issue Recruitment of pregnant women in vaccine clinical trial is challenging What is Already Known Pregnant women are more prone to accept participation in a clinical trial if the proposal is made by a midwife. What this Paper Adds Evaluation of attitudes and their determinants of midwives about vaccine clinical trial participation of pregnant women.