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

RecruitingNAAges 18 Years - 65 YearsFemaleIRCCS Azienda Ospedaliero-Universitaria di Bologna
NCT05999851 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Arterial applanation tonometry
  • In vivo endothelial glycocalyx measurement
  • Serum markers of angiogenesis and endothelial dysfunction
  • Blood chemistry test
  • Serum xanthine oxidase activity
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Where

1 site
Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy
Bologna, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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