Optimizing Participation of Pregnant Women in Clinical Trials: Factors Influencing Decisions About Participation in Medication and Vaccine Trials

Abstract

Objective: To obtain information on women's attitudes and opinions about participation in vaccine and medication trials during pregnancy.

Methods: A quantitative, cross-sectional survey was administered to 110 consenting women over a four-week period in the waiting room of an ambulatory obstetrics and gynaecology clinic in Ontario.

Results: The final response rate was 74.8%, with the majority of participants agreeing with statements about the importance of obtaining safety data about products in pregnancy and the importance of a woman having the ability to choose whether to participate in such research. Of all participants, 16.3% indicated they would consider participating in vaccine research during pregnancy and 20.0% would consider participating in medication research during pregnancy. Factors relating to maternal or fetal/child health were the most frequently cited factors influencing willingness to participate, with lack of trust in researchers and pharmaceutical companies as factors that would discourage participation.

Conclusion: A minority of pregnant women were willing to consider participating in medication or vaccine research during pregnancy. Optimizing participation requires providing women (and if appropriate, their partners) with detailed, multidisciplinary education about the maternal and fetal benefits and risks of such trials. Education about the principles of research ethics, including the limits of involvement of pharmaceutical companies, would be beneficial.

Keywords: Women's health; drug therapy; ethics; pregnancy; research; vaccines.