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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

400 Participants
are divided into 1 treatment group

Sponsors and collaborators