VOICE – Perceptions of Participation in Clinical Drug Trials During Pregnancy
Short description
VOICE explores how pregnant women with early-onset pre-eclampsia and their partners view participation in clinical drug trials during pregnancy. Through interviews with people who have been invited to participate in the PI4 clinical drug trial, the researchers aim to understand the factors that influence the decision to accept or decline participation. The study can provide important insights into how pregnant women and their partners perceive information, risks and opportunities associated with clinical research, and how future clinical drug trials during pregnancy can be designed and communicated.
Background
Pre-eclampsia can pose serious risks to both the pregnant woman and the baby. In cases of early-onset pre-eclampsia, the baby may need to be born prematurely. Clinical drug trials involving pregnant women are needed to develop better treatments.
At the same time, there is limited knowledge about how pregnant women and their partners experience the decision to participate in clinical drug trials during pregnancy and which factors influence whether they accept or decline participation.
About VOICE
VOICE is an interview study linked to the PI4 clinical drug trial, which is investigating metformin as a potential treatment for early-onset pre-eclampsia.
The study includes women who have been invited to participate in PI4 and their partners. Both those who accepted and those who declined participation in the clinical drug trial can take part.
Aim
The aim of VOICE is to explore how women with early-onset pre-eclampsia and their partners perceive participation in clinical drug trials during pregnancy. Particular attention is given to factors that encourage or discourage participation and to their experiences of being invited to take part.
Methods and significance
Participants are interviewed individually and the interviews are analysed using qualitative methods. The study can provide a better understanding of how pregnant women and their partners consider participation in clinical research.
The findings can help inform the design and communication of future clinical drug trials in ways that better take account of the perspectives and needs of pregnant women and their partners.