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| Name | Class |
|---|---|
| University of Bologna | OTHER |
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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.
Primary aim:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Principal arm | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Perfused Boundary Region (PBR) | Micron | Baseline visit (11/13+6 weeks of pregnancy) |
| Perfused Boundary Region (PBR) | Micron | Follow-up visit (24/27+6 weeks of pregnancy) |
| Carotid-femoral pulse wave velocity (cf-PWV) | m/s | Baseline visit (11/13+6 weeks of pregnancy) |
| Carotid-femoral pulse wave velocity (cf-PWV) | m/s | Follow-up visit (24/27+6 weeks of pregnancy) |
| Number of participants with hypertensive disorders of pregnancy | Number of participants diagnosed during pregnancy with any hypertensive disorder 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 with preeclampsia | Number of participants diagnosed during pregnancy with preeclampsia according to the International Society for the Study of Hypertension in Pregnancy (ISSHP) criteria. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Angiopoietin 1 (ANG-1) | ng/ml | Baseline visit (11/13+6 weeks of pregnancy) |
| Serum Angiopoietin 1 (ANG-1) | ng/ml | Follow-up visit (24/27+6 weeks of pregnancy) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum uric acid | mg/dl | Baseline visit (11/13+6 weeks of pregnancy) |
| Serum uric acid | mg/dl | Follow-up visit (24/27+6 weeks of pregnancy) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arrigo Francesco Giuseppe Cicero, MD, PhD | Contact | +39 051 214290 | arrigo.cicero@unibo.it | |
| Cristina Scollo, BD | Contact | cristina.scollo@aosp.bo.it |
| Name | Affiliation | Role |
|---|---|---|
| Arrigo Francesco Giuseppe Cicero, MD, PhD | IRCCS University Hospital of Bologna, Italy. University of Bologna, Italy. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy | Recruiting | Bologna | 40124 | Italy |
All de-identified IPD that underlie results in a publication for all primary and secondary outcome measures will be shared.
Data will be available after the associated manuscript will be published. No ad-interim analysis is planned before enrollment conclusion.
Access to IPD can be requested by qualified researchers engaging in independent scientific research, and provided after review and approval of a research proposal and execution of a Data Sharing Agreement (DSA).
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The study is a single group study (Principal Arm) with a sub-group of participants undergoing additional experimental analyses. The additional analyses will be performed in participants who will develop hypertensive disorders of pregnancy and matched (age and body mass index before conception) controls with healthy pregnancies.
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| 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). |
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| 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). |
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| Blood chemistry test | Diagnostic Test | Immunochemistry analysis of serum levels of uric acid, total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides, Lipoprotein (a) |
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| 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 |
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| Serum Angiopoietin 2 (ANG-2) | ng/ml | Baseline visit (11/13+6 weeks of pregnancy) |
| Serum Angiopoietin 2 (ANG-2) | ng/ml | Follow-up visit (24/27+6 weeks of pregnancy) |
| Serum Endothelin-1 (ET-1) | Serum concentration assessed by ELISA (pg/ml) | Baseline visit (11/13+6 weeks of pregnancy) |
| Serum Endothelin-1 (ET-1) | pg/ml | Follow-up visit (24/27+6 weeks of pregnancy) |
| Serum Intercellular adhesion molecule-1 (ICAM-1) | ng/ml | Baseline visit (11/13+6 weeks of pregnancy) |
| Serum Intercellular adhesion molecule-1 (ICAM-1) | ng/ml | Follow-up visit (24/27+6 weeks of pregnancy) |
| Serum Vascular Cell Adhesion Molecule-1 (VCAM-1) | ng/ml | Baseline visit (11/13+6 weeks of pregnancy) |
| Serum Vascular Cell Adhesion Molecule-1 (VCAM-1) | ng/ml | Follow-up visit (24/27+6 weeks of pregnancy) |
| Number of participants with long-term cardiovascular outcomes | Number of participants diagnosed with stroke, myocardial infarction, heart failure or hospitalized for cardiovascular disease in the 5 years after delivery | Interview 5 years after delivery |
| Serum lipid profile | HDL-cholesterol (mg/dl), LDL-cholesterol (mg/dl), Triglycerides (mg/dl), Lipoprotein (a) (mg/dl) | Baseline visit (11/13+6 weeks of pregnancy) |
| Serum lipid profile | HDL-cholesterol (mg/dl), LDL-cholesterol (mg/dl), Triglycerides (mg/dl), Lipoprotein (a) (mg/dl) | Follow-up visit (24/27+6 weeks of pregnancy) |
| Xanthine Oxidase Activity | mU/mL | Baseline visit (11/13+6 weeks of pregnancy) |
| Xanthine Oxidase Activity | mU/mL | Follow-up visit (24/27+6 weeks of pregnancy) |
| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D014115 | Toxemia |
| D006973 | Hypertension |
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007239 | Infections |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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