Multiparametric Assessment of Maternal Vascular Function in the Prediction of Hypertensive Disorders of Pregnancy
NCT ID: NCT05999851
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2023-09-01
2031-09-30
Brief Summary
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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.
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Detailed Description
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To determine the role of the combination of arterial tonometry and endothelial glycocalyx measurement in predicting the risk of developing hypertensive disorders in pregnancy.
Secondary aims:
* To determine the association between circulating markers of angiogenesis and endothelial dysfunction (ANG-1, ANG-2, ET-1, ICAM-1 and VCAM-1) and the development of hypertensive disorders of pregnancy.
* To define the trends of serum uric acid, lipids and xanthine oxidase activity in normotensive and hypertensive pregnancies.
* To determine the ability of the combination of arterial tonometry and endothelial glycocalyx measurement, performed in the two study visits during pregnancy, in predicting the risk of long-term maternal cardiovascular disease.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Principal arm
The entire cohort of participants will undergo all experimental procedures. Participants who will develop hypertensive disorders of pregnancy and matched participants with healthy pregnancies will also undergo serum endothelial and angiogenic markers assessment.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
FEMALE
Yes
Sponsors
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University of Bologna
OTHER
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Responsible Party
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Principal Investigators
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Arrigo Francesco Giuseppe Cicero, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
IRCCS University Hospital of Bologna, Italy. University of Bologna, Italy.
Locations
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Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy
Bologna, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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346/2023/Oss/AOUBo
Identifier Type: -
Identifier Source: org_study_id
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