Heart risk check for young women 3–6 years after pregnancy with or without placental complications.
Cardiovascular Risk Assessment in Young Women After Index Pregnancy With and Without Placental Complications
This project will test an app-based algorithm to see if it can identify cardiovascular risk in women 3–6 years after giving birth, including those who had preeclampsia or low-birth-weight infants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1260 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT07356817 on ClinicalTrials.gov |
What this trial studies
This observational study will recruit about 1,800 women from existing BiSC, EuroPE, and AngioCor cohorts who delivered 3–6 years ago and collect clinical, reproductive, lifestyle, and environmental exposure data. Investigators will compare cardiovascular markers and outcomes between women with and without pregnancy-related placental complications such as preeclampsia, preterm birth, or low birth weight. They will combine clinical measurements and patient-reported lifestyle information to derive and validate an easy-to-use prediction algorithm intended for delivery as a mobile app. The aim is to produce a risk tool tailored to younger women that accounts for pregnancy events and postnatal environment, addressing gaps in existing algorithms developed mainly in older or male populations.
Who should consider this trial
Good fit: Ideal candidates are women who participated in the BiSC, EuroPE, or AngioCor cohorts, delivered 3–6 years ago, and can give written consent to take part.
Not a fit: Women who delivered outside the 3–6 year window, who did not participate in the specified cohorts, who are unwilling to consent, or who are likely to be lost to follow-up are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, patients could get personalized, earlier heart-risk screening after pregnancy and access to a mobile tool to guide prevention.
How similar studies have performed: Previous research has established that pregnancy complications predict later cardiovascular disease, but integrating these events with lifestyle and environmental data into a validated, women-specific predictive app is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who participated in the BiSC (Barcelona Life Study Cohort), EuroPE (Randomized open-label control trial to evaluate if the incorporation of sFlt1/PlGF ratio in the diagnosis and classification of PE improves maternal and perinatal outcomes in women with suspicion of the disease; PI16/00375) and AngioCor (Cardiac dysfunction and remodeling in patients with preeclampsia regulated by antiangiogenic environment: clinical and experimental approach, PI19/00702) cohort studies * Who have delivered within the previous 3-6 years. * Give written consent when invited to participate in this study protocol. Exclusion Criteria: * Unwillingness to participate in this study * Probability of loss to follow-up.
Where this trial is running
Barcelona
- Hospital de la Santa Creu i de Sant Pau — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Elisa Llurba, PhD — Hospital de la Sant Creu i Sant Pau
- Study coordinator: Elisa Llurba Olivé, PhD
- Email: ellurba@santpau.cat
- Phone: +34 935534078
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.