Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05999851

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Preeclampsia Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Hypertensive Disorder of Pregnancy Infections Pre-Eclampsia Pregnancy Complications Toxemia Urogenital Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Bologna, 40124, Italy

Location status: Recruiting

Location contact

Arrigo Francesco Giuseppe Cicero, MD, PhD

CONTACT

[email protected]

+39051214290

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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 (eGFR≤45ml/min/1.73m2)
  • Chronic treatment with antihypertensive drugs and/or xanthine oxidase (XO) inhibitors

Treatment and study plan

Arterial applanation tonometry

Device

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.

Other names: PulsePen, Arterial stiffness measurement, Pulse wave velocity assessment

In vivo endothelial glycocalyx measurement

Device

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).

Other names: Glycocheck, Sidestream dark field microscopy

Serum markers of angiogenesis and endothelial dysfunction

Diagnostic Test

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

Other names: ANG-1, ET-1, ICAM-1, VCAM-1, ANG-2

Blood chemistry test

Diagnostic Test

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

Serum xanthine oxidase activity

Diagnostic Test

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

Primary outcomes

  1. Perfused Boundary Region (PBR)

    Time frame: Baseline visit (11/13+6 weeks of pregnancy)

    Micron

  2. Perfused Boundary Region (PBR)

    Time frame: Follow-up visit (24/27+6 weeks of pregnancy)

    Micron

  3. Carotid-femoral pulse wave velocity (cf-PWV)

    Time frame: Baseline visit (11/13+6 weeks of pregnancy)

    m/s

  4. Carotid-femoral pulse wave velocity (cf-PWV)

    Time frame: Follow-up visit (24/27+6 weeks of pregnancy)

    m/s

  5. Number of participants with hypertensive disorders of pregnancy

    Time frame: From date of enrolment until the date of first documented diagnosis of hypertensive disorder of pregnancy, according to the International Society for the Study of Hypertension in Pregnancy Criteria, assessed up to one week after delivery

    Number of participants diagnosed during pregnancy with any hypertensive disorder of pregnancy

  6. Number of participants with preeclampsia

    Time frame: From date of enrolment until the date of first documented diagnosis of preeclampsia, according to the International Society for the Study of Hypertension in Pregnancy Criteria, assessed up to one week after delivery

    Number of participants diagnosed during pregnancy with preeclampsia according to the International Society for the Study of Hypertension in Pregnancy (ISSHP) criteria.

Secondary outcomes

  1. Serum Angiopoietin 1 (ANG-1)

    Time frame: Baseline visit (11/13+6 weeks of pregnancy)

    ng/ml

  2. Serum Angiopoietin 1 (ANG-1)

    Time frame: Follow-up visit (24/27+6 weeks of pregnancy)

    ng/ml

  3. Serum Angiopoietin 2 (ANG-2)

    Time frame: Baseline visit (11/13+6 weeks of pregnancy)

    ng/ml

  4. Serum Angiopoietin 2 (ANG-2)

    Time frame: Follow-up visit (24/27+6 weeks of pregnancy)

    ng/ml

  5. Serum Endothelin-1 (ET-1)

    Time frame: Baseline visit (11/13+6 weeks of pregnancy)

    Serum concentration assessed by ELISA (pg/ml)

  6. Serum Endothelin-1 (ET-1)

    Time frame: Follow-up visit (24/27+6 weeks of pregnancy)

    pg/ml

  7. Serum Intercellular adhesion molecule-1 (ICAM-1)

    Time frame: Baseline visit (11/13+6 weeks of pregnancy)

    ng/ml

  8. Serum Intercellular adhesion molecule-1 (ICAM-1)

    Time frame: Follow-up visit (24/27+6 weeks of pregnancy)

    ng/ml

  9. Serum Vascular Cell Adhesion Molecule-1 (VCAM-1)

    Time frame: Baseline visit (11/13+6 weeks of pregnancy)

    ng/ml

  10. Serum Vascular Cell Adhesion Molecule-1 (VCAM-1)

    Time frame: Follow-up visit (24/27+6 weeks of pregnancy)

    ng/ml

  11. Number of participants with long-term cardiovascular outcomes

    Time frame: Interview 5 years after delivery

    Number of participants diagnosed with stroke, myocardial infarction, heart failure or hospitalized for cardiovascular disease in the 5 years after delivery

Other outcomes

  1. Serum uric acid

    Time frame: Baseline visit (11/13+6 weeks of pregnancy)

    mg/dl

  2. Serum uric acid

    Time frame: Follow-up visit (24/27+6 weeks of pregnancy)

    mg/dl

  3. Serum lipid profile

    Time frame: Baseline visit (11/13+6 weeks of pregnancy)

    HDL-cholesterol (mg/dl), LDL-cholesterol (mg/dl), Triglycerides (mg/dl), Lipoprotein (a) (mg/dl)

  4. Serum lipid profile

    Time frame: Follow-up visit (24/27+6 weeks of pregnancy)

    HDL-cholesterol (mg/dl), LDL-cholesterol (mg/dl), Triglycerides (mg/dl), Lipoprotein (a) (mg/dl)

  5. Xanthine Oxidase Activity

    Time frame: Baseline visit (11/13+6 weeks of pregnancy)

    mU/mL

  6. Xanthine Oxidase Activity

    Time frame: Follow-up visit (24/27+6 weeks of pregnancy)

    mU/mL

Study contacts

Contact information is provided by the study sponsor or research team.

Arrigo Francesco Giuseppe Cicero, MD, PhD

CONTACT

[email protected]

+39 051 214290

Cristina Scollo, BD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Collaborators

  • University of Bologna

Registry information

Official study title

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

Acronym: EDIPE

Important dates

Study start
2023
Primary completion
2026
Study completion
2031
First posted
Aug 21, 2023
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.