title: Participation of pregnant women in clinical trials: will they participate and why?
abstract: The objective of this study is to investigate the willingness of pregnant women to participate in a randomized placebo-controlled clinical trial, and to explore the determinants of their decision making. Cross-sectional survey with semistructured interview and thematic content analysis of pregnant women in a tiertiary care obstetric outpatient clinic. Among the 50 women surveyed, 37 (74%; 95% confidence interval, 60-85%) indicated that they would be willing to participate in a randomized placebo-controlled trial of an injectable medicine given throughout pregnancy, while 5/50 (10%; 95% confidence interval, 3-22%) would decline to participate. Potential benefit to the health of the fetus was ranked as the most important determinant for willingness to participate (68%), followed by benefit to personal health (27%), and altruism (5%). A majority of pregnant women would be willing to participate in a randomized placebo-controlled clinical trial. Pregnant women appear to be willing to accept risks to themselves, if there is a chance that participation in a clinical trial would help their pregnancy and improve their baby's health.
authors.affiliation: Thrombosis and Hemostasis Program, Division of Hematology, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: Marc A
authors.initials: MA
authors.lastname: Rodger
authors.forename: Dimitri
authors.initials: D
authors.lastname: Makropoulos
authors.forename: Mark
authors.initials: M
authors.lastname: Walker
authors.forename: Erin
authors.initials: E
authors.lastname: Keely
authors.forename: Alan
authors.initials: A
authors.lastname: Karovitch
authors.forename: Philip S
authors.initials: PS
authors.lastname: Wells
mesh_terms: D000704:Analysis of Variance; D001294:Attitude to Health; D003430:Cross-Sectional Studies; D003657:Decision Making; D005260:Female; D006801:Humans; D009864:Ontario; D010342:Patient Acceptance of Health Care; D010349:Patient Compliance; D010358:Patient Participation / Q000523:psychology*; D011247:Pregnancy; D037841:Pregnant People / Q000523:psychology*; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D011795:Surveys and Questionnaires