Registry of PRO(M)s and PRE(M)s for pregnant women with CVD
Research type
Research Study
Full title
Development of a registry of clinical and patient-reported outcomes for pregnant women with cardiovascular conditions
IRAS ID
350663
Contact name
Linden Stocker
Contact email
Sponsor organisation
Internal Research Fund University of Antwerp
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 10 months, 24 days
Research summary
This project aims to improve the care of pregnant women with cardiovascular disease (CVD) by developing and collecting a core set of patient-reported outcomes (PROs) and patient-reported experiences (PREs) in addition to clinical outcomes.
First, this study will develop a standardised set of PROs and PREs based on expert consensus through a Delphi or expert panel. This core set can be used in the follow-up of these patients, with special attention to their psychosocial well-being. The panel, consisting of healthcare providers and women who have experienced pregnancy with CVD, will participate in two rounds of focus groups and/or online surveys. First, focus groups will be organised to generate a comprehensive list of all relevant patient-reported outcomes in this population. In a second step, online surveys will be conducted to identify, refine and prioritise outcomes and measurement tools. This iterative process aims to achieve broad consensus on clinically relevant outcomes and their timing.
Second, this study will monitor this set of PROs and PREs during pregnancy and postpartum. These outcomes will evaluate the follow-up of these patients, with particular attention to their psychosocial well-being. Women with congenital, acquired and/or genetic cardiovascular disease will be recruited consecutively. Potential candidates will voluntarily receive all information about the study and will be given the opportunity to register online if they are interested in participating in the study. After signing an informed consent form, participants will receive questionnaires via an online form or by post, depending on their preference.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
25/SC/0065
Date of REC Opinion
29 May 2025
REC opinion
Further Information Favourable Opinion