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

This trial accepts healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Arterial applanation tonometry

    Device

    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

    Device

    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

    Diagnostic test

    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

    Diagnostic test

    Immunochemistry analysis of serum levels of uric acid, total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides, Lipoprotein (a)

  • Serum xanthine oxidase activity

    Diagnostic test

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

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: Principal armExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Perfused Boundary Region (PBR)

Micron

Time frame
Baseline visit (11/13+6 weeks of pregnancy)
2

Perfused Boundary Region (PBR)

Micron

Time frame
Follow-up visit (24/27+6 weeks of pregnancy)
3

Carotid-femoral pulse wave velocity (cf-PWV)

m/s

Time frame
Baseline visit (11/13+6 weeks of pregnancy)
4

Carotid-femoral pulse wave velocity (cf-PWV)

m/s

Time frame
Follow-up visit (24/27+6 weeks of pregnancy)

Secondary outcomes

1

Serum Angiopoietin 1 (ANG-1)

ng/ml

Time frame
Baseline visit (11/13+6 weeks of pregnancy)
2

Serum Angiopoietin 1 (ANG-1)

ng/ml

Time frame
Follow-up visit (24/27+6 weeks of pregnancy)
3

Serum Angiopoietin 2 (ANG-2)

ng/ml

Time frame
Baseline visit (11/13+6 weeks of pregnancy)
4

Serum Angiopoietin 2 (ANG-2)

ng/ml

Time frame
Follow-up visit (24/27+6 weeks of pregnancy)

Other outcomes

1

Serum uric acid

mg/dl

Time frame
Baseline visit (11/13+6 weeks of pregnancy)
2

Serum uric acid

mg/dl

Time frame
Follow-up visit (24/27+6 weeks of pregnancy)
3

Serum lipid profile

HDL-cholesterol (mg/dl), LDL-cholesterol (mg/dl), Triglycerides (mg/dl), Lipoprotein (a) (mg/dl)

Time frame
Baseline visit (11/13+6 weeks of pregnancy)
4

Serum lipid profile

HDL-cholesterol (mg/dl), LDL-cholesterol (mg/dl), Triglycerides (mg/dl), Lipoprotein (a) (mg/dl)

Time frame
Follow-up visit (24/27+6 weeks of pregnancy)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.