Am J Perinatol 2003; 20(2): 069-076
DOI: 10.1055/s-2003-38318
Copyright © 2003 by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA. Tel.: +1(212) 584-4693

Participation of Pregnant Women in Clinical Trials: Will They Participate and Why?

Marc A. Rodger1,2 , Dimitri Makropoulos1 , Mark Walker2 , Erin Keely1 , Alan Karovitch1 , Philip S. Wells1,2
  • 1Department of Medicine and Department of Obstetrics and Gynecology, University of Ottawa, Ottawa, Ontario, Canada
  • 2Clinical Epidemiology Unit, Ottawa Health Research Institute, Ottawa, Ontario, Canada
Further Information

Publication History

Publication Date:
27 March 2003 (online)

Zoom Image

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.