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

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.

Conditions

• Preeclampsia
• Hypertensive Disorder of Pregnancy

Interventions

DEVICE

Arterial 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.

DEVICE

In 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_TEST

Serum 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_TEST

Blood chemistry test

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

DIAGNOSTIC_TEST

Serum xanthine oxidase activity

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

Sponsors & Collaborators

• University of Bologna

  collaborator OTHER

• IRCCS Azienda Ospedaliero-Universitaria di Bologna

  lead OTHER

Principal Investigators

• Arrigo Francesco Giuseppe Cicero, MD, PhD · IRCCS University Hospital of Bologna, Italy. University of Bologna, Italy.

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-09-01

Primary Completion

2026-05-31

Completion

2031-09-30

FDA Device

Yes

Countries

• Italy

Study Locations