Withholding consent to participate in clinical trials: decisions of pregnant women

Abstract

Objective To identify factors affecting the decision of pregnant women to withhold their consent to Design A qualitative, cross-sectional, retrospective study using semi-structured interviews with Setting Patients' homes.Participants Eighteen women who had been invited previously to participate in a clinical trial in pregnancy, but who had declined. ResultsThe invitation to participate in a clinical trial when pregnant has different implications for different women, and the meanings they ascribe to the invitation to participate will affect the likelihood of them participating. Apregnant woman may feel the pressure of conflicting duties: a protective duty to the fetus and to be a 'good citizen' when asked to participate in research. The sharing of information during the recruitment phase has a crucial bearing on how the invitation will be received. The design of the trial, the type and style of information available, the manner in which it is conveyed, the timing and process of the invitation and by whom it is made all affect the likelihood of a woman agreeing to take part.By asking for the contribution of these women, this study identified factors that can influence the chances of an individual entering a trial or not. Contextualising and personalising risk is important in the consent process as recruiting women when pregnant can be difficult and hinder research. From these comments recommendations for future research involving pregnant women participate in a clinical trial. thematic content analysis. Conclusionhave been drawn up.

Deciding to join a perinatal randomised controlled trial: Experiences and views of pregnant women enroled in the Magpie Trial

“…Our findings are similar to those of Mohanna (Mohanna and Tunna, 1999) in their study of pregnant women's decisions to withhold consent to a preterm labour trial. In that study, most of the women had not considered they were at risk of preterm labour and therefore could not see the relevance of being told early about the trial.…”

“…Issues regarding the randomisation of pregnant women have been identified as needing special consideration (Mohanna, 1997), (Mohanna and Tunna, 1999), (Lupton and Williams, 2004). Women undoubtedly feel responsible for the child they carry to the extent that they often modify their habits and lifestyle during pregnancy.…”

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.…”

“…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. 94,95 The need for a large simple trial of vesicoamniotic shunting compared with conservative management for lower urinary tract obstruction…”

“…A literature search revealed that there were few studies 93,94 examining women's reasons for declining to participate in trials and the factors that may affect consent in pregnancy. We found no studies that specifically looked at trials of a surgical intervention in pregnancy.…”