Investigating cardiovascular risks in women after complicated pregnancies
PlacEntal Acute Atherosis RefLecting Subclinical Atherosclerosis
This study looks at how having high blood pressure during pregnancy might affect women's heart health later on and whether certain blood tests can help predict their risk for heart problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 226 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 1 site (Maastricht) |
| Trial ID | NCT05500989 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between placental acute atherosis in women who experienced pre-eclampsia and their future risk of developing subclinical atherosclerosis. By comparing women with pre-eclamptic pregnancies to those with uncomplicated pregnancies, the study seeks to identify cardiovascular adaptations during pregnancy and their persistence postpartum. Participants will undergo follow-up assessments at two intervals: 6 to 36 months and 10 to 20 years after delivery. The study also aims to identify blood biomarkers that could predict cardiovascular disease risk earlier in women with hypertensive pregnancies.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older who have experienced pre-eclampsia or HELLP syndrome during their pregnancy.
Not a fit: Patients with pre-existing chronic hypertension or autoimmune disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and prevention strategies for cardiovascular disease in women with a history of complicated pregnancies.
How similar studies have performed: While the specific approach of this study is novel, previous studies have indicated a link between complicated pregnancies and long-term cardiovascular risks, suggesting potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged ≥ 18 years * Controls: Women with an uncomplicated pregnancy at the moment of inclusion (i.e no foetal or maternal placental complications, such as pregnancy induced hypertension, preeclampsia or HELLP-syndrome, or small for gestational birth infancies) * Cases: Women diagnosed with a preeclamptic pregnancy at the moment of inclusion Exclusion Criteria: • Women who do not want to be informed about the results of the tests, or women who do not want their general practitioner and specialist(s) to be informed about the test results * Allergy or intolerance to glyceryl trinitrate, betablockers or iodinated contrast media. * Controls: Pre-existing chronic hypertension treated with antihypertensive medication or autoimmune disorder.
Where this trial is running
Maastricht
- Maastricht University Medical Center (MUMC+) — Maastricht, Netherlands (Recruiting)
Study contacts
- Principal investigator: Marc Spaanderman, MD, PhD — Maastricht University Medical Center
- Study coordinator: Gwyneth Jansen, MBBS
- Email: gwyneth.jansen@mumc.nl
- Phone: 043-38774145
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.