Reasons for accepting or declining participation in the ASPRE trial: A qualitative study with women at high risk of preterm pre-eclampsia.

Abstract

To identify factors that affected the decision of pregnant women at high risk for pre-eclampsia (PE) in accepting or declining participation in a medicated clinical trial (ASPRE) for the prevention of preterm PE. This was a qualitative, cross-sectional study. A purposive sample of 14 participants and 13 decliners of the ASPRE trial were interviewed using semi-structured interviews. Data were analysed using template analysis. For participants, their high-risk status seems to have motivated them to take part in the trial. This was enabled by their perception that the trial drug aspirin was commonly used, the safety of the procedure, and the belief that they will be in receipt of extra monitoring in pregnancy. Decliners expressed discomfort about taking medications in pregnancy, and about the presence of the placebo arm; they seemed to be motivated by desire to reduce harm. Satisfaction with the information provided by the medical professionals was also influential in women's decision making, and so were the views of their partners and other trusted individuals. Pregnant women's motivation to take part or to decline participation in a medicated trail can be understood as an attempt to cope with the threat posed by their high-risk status.