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Multiparametric Assessment of Maternal Vascular Function as a New Diagnostic and Prognostic Tool for Hypertensive Disorders of Pregnancy and Preeclampsia - EDIPE Study
The present study is a single-centre prospective study that will enrol pregnant women during their first trimester of pregnancy (11+0 - 13+6 weeks of gestation). During pregnancy, women will undergo standard clinical evaluation and management. During the two study visits (enrollment and 24+0 - 27+6 weeks of gestation) the investigators will perform arterial tonometry (Pulsepen) and in vivo darkfield microscopy (Glycocheck) to evaluate endothelial and vascular function. A urine sample and a blood sample for specific study analyses on metabolic profile, endothelial and angiogenic markers will be collected. Pregnancy outcomes will be collected at delivery and five years after delivery all the participants will be interview to collect long-term cardiovascular outcomes. Serum endothelial and angiogenic markers will be evaluated only in participants who will develop hypertensive disorders of pregnancy and in an equal number of controls matched for age and body mass index at the time of conception.
Primary aim: To determine the role of the combination of arterial tonometry and endothelial glycocalyx measurement in predicting the risk of developing hypertensive disorders in pregnancy. Secondary aims: * To determine the association between circulating markers of angiogenesis and endothelial dysfunction (ANG-1, ANG-2, ET-1, ICAM-1 and VCAM-1) and the development of hypertensive disorders of pregnancy. * To define the trends of serum uric acid, lipids and xanthine oxidase activity in normotensive and hypertensive pregnancies. * To determine the ability of the combination of arterial tonometry and endothelial glycocalyx measurement, performed in the two study visits during pregnancy, in predicting the risk of long-term maternal cardiovascular disease.
Age
18 - 65 years
Sex
FEMALE
Healthy Volunteers
Yes
Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy
Bologna, Italy
Start Date
September 1, 2023
Primary Completion Date
May 1, 2026
Completion Date
September 1, 2031
Last Updated
January 22, 2026
400
ESTIMATED participants
Arterial applanation tonometry
DEVICE
In vivo endothelial glycocalyx measurement
DEVICE
Serum markers of angiogenesis and endothelial dysfunction
DIAGNOSTIC_TEST
Blood chemistry test
DIAGNOSTIC_TEST
Serum xanthine oxidase activity
DIAGNOSTIC_TEST
Lead Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators
NCT07485140
NCT06749418
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07204756