Actively Recruiting
Led by Maastricht University Medical Center · Updated on 2024-12-05
226
Participants Needed
1
Research Sites
N/A
Total Duration
Pregnancy acts like a cardiovascular stress test, and complicated pregnancies such as those with pre-eclampsia or HELLP syndrome are linked to a higher risk of cardiovascular disease later on. Researchers are studying how the heart adapts during pregnancy and how these changes may or may not reverse over months or years after delivery. This study aims to understand these processes better and identify factors that could be targeted to reduce future cardiovascular risk. This observational study follows women with pre-eclamptic pregnancies and those with uncomplicated pregnancies to compare their heart and vascular health over time. Women are grouped as controls with uncomplicated pregnancies or cases with pre-eclampsia and/or HELLP syndrome, with further subdivision based on early or late onset and presence of intrauterine growth restriction. Placental tissue is collected after delivery for analysis. Follow-up visits occur at 6 to 36 months or 10 to 20 years postpartum, including heart imaging, blood tests, and vascular assessments. Participants attend detailed visits lasting about 5 hours, undergoing CT angiography, echocardiography, blood pressure and weight measurements, questionnaires, and blood and exhaled air collection. Some tests may include glycocalyx measurement and FibroScan. The study monitors the relationship between placental vascular changes and coronary artery health, aiming to predict future cardiovascular risk and inform prevention strategies. Safety monitoring includes standard blood draws with minimal risk and clinical advice based on risk profiles.
CONDITIONS
PlacEntal Acute Atherosis RefLecting Subclinical Atherosclerosis
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Delivery period (single event)
After delivery, the placenta is collected and undergoes histopathological analysis to assess placental acute atherosis and decidual vasculopathy.
1 visit (in-person at delivery)
Duration - 6 to 36 months postpartum
Participants attend a follow-up visit including CT angiography, echocardiography, blood sampling, vascular measurements, and questionnaires to evaluate cardiovascular risk and biomarkers.
1 visit lasting approximately 5 hours (in-person)
Duration - 10 to 20 years postpartum
Participants attend a long-term follow-up visit with comprehensive cardiovascular assessments including imaging, blood tests, and vascular function measurements to monitor long-term cardiovascular health.
1 visit lasting approximately 5 hours (in-person)
Total: 1 location
1
Maastricht University Medical Center (MUMC+)
Maastricht, Netherlands, 6202 AZ
Actively Recruiting
G
Gwyneth Jansen, MBBS
M
Marc Spaanderman, MD, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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Gwyneth Jansen, Robert-Jan Alers, Emma Bnj Janssen...
https://pubmed.ncbi.nlm.nih.gov/40413047