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

Condition(s) studied

Investigational drug(s) / intervention(s)

Arterial applanation tonometry: Arterial 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: The 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: ELISA 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: Immunochemistry analysis of serum levels of uric acid, total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides, Lipoprotein (a)

Serum xanthine oxidase activity: Serum xanthine oxidase (XO) activity will be assessed in blood samples measuring the ability of XO to produce uric acid

Study summary

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

Primary outcome measure(s)

• Perfused Boundary Region (PBR) — Baseline visit (11/13+6 weeks of pregnancy)
  Micron
• Perfused Boundary Region (PBR) — Follow-up visit (24/27+6 weeks of pregnancy)
  Micron
• Carotid-femoral pulse wave velocity (cf-PWV) — Baseline visit (11/13+6 weeks of pregnancy)
  m/s
• Carotid-femoral pulse wave velocity (cf-PWV) — Follow-up visit (24/27+6 weeks of pregnancy)
  m/s
• Number of participants with hypertensive disorders of pregnancy — From date of enrolment until the date of first documented diagnosis of hypertensive disorder of pregnancy, according to the International Society for the Study of Hypertension in Pregnancy Criteria, assessed up to one week after delivery
  Number of participants diagnosed during pregnancy with any hypertensive disorder of pregnancy
• Number of participants with preeclampsia — From date of enrolment until the date of first documented diagnosis of preeclampsia, according to the International Society for the Study of Hypertension in Pregnancy Criteria, assessed up to one week after delivery
  Number of participants diagnosed during pregnancy with preeclampsia according to the International Society for the Study of Hypertension in Pregnancy (ISSHP) criteria.

Trial sites (1)

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