Participation of pregnant women in clinical trials: will they participate and why?

Full 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.

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Author information

Author/s: Rodger, Marc A (MA); Makropoulos, Dimitri (D); Walker, Mark (M); Keely, Erin (E); Karovitch, Alan (A); Wells, Philip S (PS);

Affiliation: Thrombosis and Hemostasis Program, Division of Hematology, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.

Journal and publication information

Publication Type: Journal Article

Journal: American journal of perinatology (Am J Perinatol), published in United States. (Language: eng)

Reference: 2003-Feb; vol 20 (issue 2) : pp 69-76

Dates: Created 2003/03/27; Completed 2003/07/07; Revised 2007/11/15;

PMID: 12660911, status: MEDLINE (last retrieval date: 11/6/2008)

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Patient Acceptance of Health Care
Patient Compliance
Patient Participation - psychology
Pregnancy
Pregnant Women - psychology
Questionnaires
Randomized Controlled Trials as Topic - methods

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