Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
FEMALE
Healthy Volunteers
NCT05999851

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

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2026-01-22

400

Participants Needed

1

Research Sites

417 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

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than or equal to 18 years
  • Single pregnancy
  • No previous pregnancies lasting more than 12 weeks
  • Willing and able to give informed consent for participation in the study
Not Eligible

You will not qualify if you...

  • Intermediate-high risk of genetic abnormalities or need for invasive prenatal tests (amniocentesis, villocentesis)
  • History of solid organ or hematopoietic stem cell transplantation
  • Chronic renal failure (eGFR 64; 45 ml/min/1.73 m2)
  • Chronic treatment with antihypertensive drugs and/or xanthine oxidase inhibitors

AI-Screening

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Trial Site Locations

Total: 1 location

1

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

Bologna, Italy, 40124

Actively Recruiting

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Research Team

A

Arrigo Francesco Giuseppe Cicero, MD, PhD

CONTACT

C

Cristina Scollo, BD

CONTACT

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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