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.

Attitude towards clinical trials: Results of a survey of persons interested in research

“…By contrast the general willingness of the population to participate in clinical trials in different countries but also in Germany was generally less pronounced at around 25 -35 % [4], whereby in individual countries (e. g. USA, [8,13]) and also with regard to special groups (e. g. pregnant women, [12]) a significantly higher potential participation rate was determined. In a survey on persons with a chronic disease in Germany, the willingness to participate amounted to 13 % [3].…”

The Percutaneous shunting in Lower Urinary Tract Obstruction (PLUTO) study and randomised controlled trial: evaluation of the effectiveness, cost-effectiveness and acceptability of percutaneous vesicoamniotic shunting for lower urinary tract obstruction

“…We found no studies that specifically looked at trials of a surgical intervention in pregnancy. Factors that appear to negatively influence participation in trials during pregnancy are the existence of a placebo arm 93,94 and a belief by mothers that they are not entitled to place their fetus at risk. 93 Positive influences include the potential or perceived benefit to the fetus.…”

“…93 Positive influences include the potential or perceived benefit to the fetus. 94,95 The need for a large simple trial of vesicoamniotic shunting compared with conservative management for lower urinary tract obstruction…”

Special population considerations and regulatory affairs for clinical research

“…As research participants, pregnant women are generally willing to participate in non-invasive research (27); however, any research that imposes risk must take into account both the mother and the unborn (28). As with other populations, it is important to clearly inform potential participants about the nature of the study and address concerns early.…”