Actively Recruiting
Multiparametric Assessment of Maternal Vascular Function as a New Diagnostic and Prognostic Tool for Hypertensive Disorders of Pregnancy and Preeclampsia - EDIPE Study
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2026-01-22
400
Participants Needed
1
Research Sites
278 weeks
Total Duration
On this page
Sponsors
I
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead Sponsor
U
University of Bologna
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how measurements of maternal blood vessel function during early pregnancy can help predict the risk of developing hypertensive disorders like preeclampsia. This study focuses on pregnant women in their first trimester and aims to understand how blood vessel behavior and certain blood markers relate to pregnancy complications and long-term cardiovascular health. Participants will have two main study visits: one in the first trimester (11 to 13 weeks) and a follow-up visit in the second trimester (24 to 27 weeks). At each visit, devices will be used to measure arterial stiffness and the function of the inner lining of small blood vessels. Blood and urine samples will be collected to analyze metabolic and vascular markers. Women who develop hypertensive disorders and matched healthy participants will have additional blood tests to assess specific proteins linked to blood vessel health. Throughout pregnancy, standard medical care will continue alongside these assessments. Researchers will track pregnancy outcomes at delivery and conduct interviews five years later to monitor long-term heart health. Primary measures include changes in blood vessel function and the incidence of hypertensive disorders. Secondary measures focus on blood proteins and enzymes related to blood vessel function and future cardiovascular risks.
CONDITIONS
Brief Title
Multiparametric Assessment of Maternal Vascular Function in the Prediction of Hypertensive Disorders of Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than or equal to 18 years
- Single pregnancy
- No previous pregnancies lasting more than 12 weeks
- Participant willing and able to give informed consent for participation in the study
You will not qualify if you...
- Intermediate-high risk of genetic abnormalities and/or need to perform invasive tests (amniocentesis, villocentesis)
- History of solid organ or hematopoietic stem cell transplantation
- Chronic renal failure (eGFR45ml/min/1.73m2)
- Chronic treatment with antihypertensive drugs and/or xanthine oxidase (XO) inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From approximately 11 to 27+6 weeks of pregnancy
Participants undergo two study visits during pregnancy where arterial tonometry and endothelial glycocalyx measurements are performed to assess vascular function. Blood samples are collected to measure serum markers of angiogenesis, endothelial dysfunction, uric acid, lipids, and xanthine oxidase activity.
2 visits (in-person) during pregnancy at baseline (11 to 13+6 weeks) and follow-up (24 to 27+6 weeks)
Duration - 5 years after delivery
Participants are followed up for long-term cardiovascular outcomes through an interview conducted 5 years after delivery.
1 follow-up interview
Trial Site Locations
Total: 1 location
1
Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy
Bologna, Italy, 40124
Actively Recruiting
Research Team
A
Arrigo Francesco Giuseppe Cicero, MD, PhD
C
Cristina Scollo, BD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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