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
This trial accepts healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
Arterial applanation tonometry
DeviceArterial 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.
In vivo endothelial glycocalyx measurement
DeviceThe 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).
Serum markers of angiogenesis and endothelial dysfunction
Diagnostic testELISA assays to measure serum circulating markers of angiogenesis and endothelial dysfunction (ANG-1, ANG-2, ET-1, ICAM-1 and VCAM-1).
Blood chemistry test
Diagnostic testImmunochemistry analysis of serum levels of uric acid, total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides, Lipoprotein (a)
Serum xanthine oxidase activity
Diagnostic testSerum xanthine oxidase (XO) activity will be assessed in blood samples measuring the ability of XO to produce uric acid
Treatment groups
Trial outcomes
Primary outcomes
Perfused Boundary Region (PBR)
Micron
Perfused Boundary Region (PBR)
Micron
Carotid-femoral pulse wave velocity (cf-PWV)
m/s
Carotid-femoral pulse wave velocity (cf-PWV)
m/s
Secondary outcomes
Serum Angiopoietin 1 (ANG-1)
ng/ml
Serum Angiopoietin 1 (ANG-1)
ng/ml
Serum Angiopoietin 2 (ANG-2)
ng/ml
Serum Angiopoietin 2 (ANG-2)
ng/ml
Other outcomes
Serum uric acid
mg/dl
Serum uric acid
mg/dl
Serum lipid profile
HDL-cholesterol (mg/dl), LDL-cholesterol (mg/dl), Triglycerides (mg/dl), Lipoprotein (a) (mg/dl)
Serum lipid profile
HDL-cholesterol (mg/dl), LDL-cholesterol (mg/dl), Triglycerides (mg/dl), Lipoprotein (a) (mg/dl)
Sponsors and contacts
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead sponsor
University of Bologna
Collaborator