Multiparametric Assessment of Maternal Vascular Function in the Prediction of Hypertensive Disorders of Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Arterial applanation tonometry, In vivo endothelial glycocalyx measurement, Serum markers of angiogenesis and endothelial dysfunction, Blood chemistry test.
- Who it may be relevant to
- Registry conditions: Preeclampsia, Hypertensive Disorder of Pregnancy. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multiparametric Assessment of Maternal Vascular Function as a New Diagnostic and Prognostic Tool for Hypertensive Disorders of Pregnancy and Preeclampsia - EDIPE Study
Overview
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.
Detailed description
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:
* 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.
Interventions
- Device 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. - Device 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). - Diagnostic test 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). - Diagnostic test Blood chemistry test
Immunochemistry analysis of serum levels of uric acid, total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides, Lipoprotein (a) - Diagnostic test Serum xanthine oxidase activity
Serum xanthine oxidase (XO) activity will be assessed in blood samples measuring the ability of XO to produce uric acid
Primary outcome measures
- Perfused Boundary Region (PBR) [Time frame: Baseline visit (11/13+6 weeks of pregnancy)]
- Perfused Boundary Region (PBR) [Time frame: Follow-up visit (24/27+6 weeks of pregnancy)]
- Carotid-femoral pulse wave velocity (cf-PWV) [Time frame: Baseline visit (11/13+6 weeks of pregnancy)]
- Carotid-femoral pulse wave velocity (cf-PWV) [Time frame: Follow-up visit (24/27+6 weeks of pregnancy)]
- Number of participants with hypertensive disorders of pregnancy [Time frame: 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 [Time frame: 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]
Secondary outcome measures (11)
- Serum Angiopoietin 1 (ANG-1) [Time frame: Baseline visit (11/13+6 weeks of pregnancy)]
- Serum Angiopoietin 1 (ANG-1) [Time frame: Follow-up visit (24/27+6 weeks of pregnancy)]
- Serum Angiopoietin 2 (ANG-2) [Time frame: Baseline visit (11/13+6 weeks of pregnancy)]
- Serum Angiopoietin 2 (ANG-2) [Time frame: Follow-up visit (24/27+6 weeks of pregnancy)]
- Serum Endothelin-1 (ET-1) [Time frame: Baseline visit (11/13+6 weeks of pregnancy)]
- Serum Endothelin-1 (ET-1) [Time frame: Follow-up visit (24/27+6 weeks of pregnancy)]
- Serum Intercellular adhesion molecule-1 (ICAM-1) [Time frame: Baseline visit (11/13+6 weeks of pregnancy)]
- Serum Intercellular adhesion molecule-1 (ICAM-1) [Time frame: Follow-up visit (24/27+6 weeks of pregnancy)]
- Serum Vascular Cell Adhesion Molecule-1 (VCAM-1) [Time frame: Baseline visit (11/13+6 weeks of pregnancy)]
- Serum Vascular Cell Adhesion Molecule-1 (VCAM-1) [Time frame: Follow-up visit (24/27+6 weeks of pregnancy)]
- Number of participants with long-term cardiovascular outcomes [Time frame: Interview 5 years after delivery]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Italy · 1 center
- Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Ital — Bologna
Identifiers
NCT: NCT05999851 · 346/2023/Oss/AOUBo