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

Recruiting · NCT05999851 · Interventional (participants receive a specific treatment) · Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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Hypertension

Interventions studied

Arterial applanation tonometryBlood chemistry testIn vivo endothelial glycocalyx measurementSerum markers of angiogenesis and endothelial dysfunctionSerum xanthine oxidase activity

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.

Who can take part

Age range

18 Years to 65 Years

Sex

Female

Healthy volunteers

Yes - healthy volunteers may be accepted

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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

Where it is running

1 location listed.

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

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →