RecruitingNot ApplicableNCT05999851

Multiparametric Assessment of Maternal Vascular Function in the Prediction of Hypertensive Disorders of Pregnancy

Multiparametric Assessment of Maternal Vascular Function as a New Diagnostic and Prognostic Tool for Hypertensive Disorders of Pregnancy and Preeclampsia - EDIPE Study


Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

400 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study enrolls first-time pregnant women to monitor blood vessel health throughout pregnancy and test whether early measurements can predict who will develop high blood pressure during pregnancy (such as preeclampsia). **You may be eligible if...** - You are 18 years or older - This is your first pregnancy (no previous pregnancies beyond 12 weeks) - You are carrying a single baby - You are willing and able to give informed consent **You may NOT be eligible if...** - You are at high risk of genetic problems in the baby requiring invasive testing (like amniocentesis) - You have had a previous organ transplant or bone marrow transplant - You have significant chronic kidney disease (eGFR of 45 or below) - You are currently taking blood pressure medications or xanthine oxidase inhibitors (drugs used for gout, such as allopurinol) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEArterial applanation tonometry

Arterial applanation tonometry will be performed at the carotid and femoral level by the PulsePen device (Software WPulsePen version 2.3.1, DiaTecne, Milan, Italy), while the subject is lying in the horizontal position and after 5 minutes of rest.

DEVICEIn vivo endothelial glycocalyx measurement

The in vivo microscopy (GlycoCheck system) is performed in the sublingual capillaries during the morning, with the participant sitting on a chair. The sublingual capillaries are visualized using an SDF video microscope (Capiscope handheld, KK Research technology Ltd).

DIAGNOSTIC_TESTSerum markers of angiogenesis and endothelial dysfunction

ELISA assays to measure serum circulating markers of angiogenesis and endothelial dysfunction (ANG-1, ANG-2, ET-1, ICAM-1 and VCAM-1).

DIAGNOSTIC_TESTBlood chemistry test

Immunochemistry analysis of serum levels of uric acid, total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides, Lipoprotein (a)

DIAGNOSTIC_TESTSerum xanthine oxidase activity

Serum xanthine oxidase (XO) activity will be assessed in blood samples measuring the ability of XO to produce uric acid


Locations(1)

Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy

Bologna, Italy

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NCT05999851


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