PreeclampsiaEDIPENCT05999851
Multiparametric Assessment of Maternal Vascular Function in the Prediction of Hypertensive Disorders of Pregnancy
A study testing Arterial applanation tonometry, In vivo endothelial glycocalyx measurement and Serum markers of angiogenesis and endothelial dysfunction in people with Preeclampsia and Hypertensive Disorder of Pregnancy, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Hypertensive Disorder of Pregnancy
- What is being tested?
- Arterial applanation tonometry, In vivo endothelial glycocalyx measurement and Serum markers of angiogenesis and endothelial dysfunction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2023to Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cristina Scollo, BD contact
Italy1 site, 1 recruiting
- Recruiting
Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy
Bologna, 40124
Arrigo Francesco Giuseppe Cicero, MD, PhD, +39051214290, arrigo.cicero@unibo.it
About this study
Official title: Multiparametric Assessment of Maternal Vascular Function as a New Diagnostic and Prognostic Tool for Hypertensive Disorders of Pregnancy and Preeclampsia - EDIPE Study
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.
Read the 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.
- Conditions
- Preeclampsia, Hypertensive Disorder of Pregnancy
- Being tested
- Arterial applanation tonometry, In vivo endothelial glycocalyx measurement, Serum markers of angiogenesis and endothelial dysfunction, Blood chemistry test, Serum xanthine oxidase activity
- Keywords
- Preeclampsia, Hypertensive Disorders of Pregnancy, Hypertension, Obstetric Medicine, Cardio-Obstetrics, Cardiovascular outcomes, Pregnancy complications, Arterial Stiffness, Endothelial Glycocalyx, Endothelial dysfunction, Uric Acid, Oxidative stress, Xanthine oxidase, Lipids
- Medical subject headings
- Pre-Eclampsia, Toxemia, Hypertension, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial applanation tonometryDevice
Also called PulsePen, Arterial stiffness measurement, Pulse wave velocity assessment
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 measurementDevice
Also called Glycocheck, Sidestream dark field microscopy
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 dysfunctionDiagnostic test
Also called ANG-1, ET-1, ICAM-1, VCAM-1
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 testDiagnostic test
Immunochemistry analysis of serum levels of uric acid, total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides, Lipoprotein (a)
Serum xanthine oxidase activityDiagnostic test
Serum xanthine oxidase (XO) activity will be assessed in blood samples measuring the ability of XO to produce uric acid
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Arterial applanation tonometry; Device: In vivo endothelial glycocalyx measurement; Diagnostic Test: Serum markers of angiogenesis and endothelial dysfunction; Diagnostic Test: Blood chemistry test; Diagnostic Test: Serum xanthine oxidase activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfused Boundary Region (PBR)
Micron
Measured: Baseline visit (11/13+6 weeks of pregnancy)
Perfused Boundary Region (PBR)
Micron
Measured: Follow-up visit (24/27+6 weeks of pregnancy)
Carotid-femoral pulse wave velocity (cf-PWV)
m/s
Measured: Baseline visit (11/13+6 weeks of pregnancy)
Carotid-femoral pulse wave velocity (cf-PWV)
m/s
Measured: 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
Measured: 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.
Measured: 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 outcomes (11)
Serum Angiopoietin 1 (ANG-1)
ng/ml
Measured: Baseline visit (11/13+6 weeks of pregnancy)
Serum Angiopoietin 1 (ANG-1)
ng/ml
Measured: Follow-up visit (24/27+6 weeks of pregnancy)
Serum Angiopoietin 2 (ANG-2)
ng/ml
Measured: Baseline visit (11/13+6 weeks of pregnancy)
Serum Angiopoietin 2 (ANG-2)
ng/ml
Measured: Follow-up visit (24/27+6 weeks of pregnancy)
Serum Endothelin-1 (ET-1)
Serum concentration assessed by ELISA (pg/ml)
Measured: Baseline visit (11/13+6 weeks of pregnancy)
Serum Endothelin-1 (ET-1)
pg/ml
Measured: Follow-up visit (24/27+6 weeks of pregnancy)
Serum Intercellular adhesion molecule-1 (ICAM-1)
ng/ml
Measured: Baseline visit (11/13+6 weeks of pregnancy)
Serum Intercellular adhesion molecule-1 (ICAM-1)
ng/ml
Measured: Follow-up visit (24/27+6 weeks of pregnancy)
Serum Vascular Cell Adhesion Molecule-1 (VCAM-1)
ng/ml
Measured: Baseline visit (11/13+6 weeks of pregnancy)
Serum Vascular Cell Adhesion Molecule-1 (VCAM-1)
ng/ml
Measured: 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
Measured: Interview 5 years after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Sep 2023
- Primary completionMay 2026 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bologna
- Responsible party
- Sponsor
- Investigators
- Arrigo Francesco Giuseppe Cicero, MD, PhD, Principal investigator, IRCCS University Hospital of Bologna, Italy. University of Bologna, Italy.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999851
- Sponsor's protocol ID
- 346/2023/Oss/AOUBo
- Acronym
- EDIPE
- Status last verified
- Nov 2025
- First submitted
- 15 Jun 2023
- Last updated
- 22 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All de-identified IPD that underlie results in a publication for all primary and secondary outcome measures will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric Assessment of Maternal Vascular Function as a New Diagnostic and Prognostic Tool for Hypertensive Disorders of Pregnancy and Preeclampsia - EDIPE Study
- ClinicalTrials.gov ID
- NCT05999851
- Acronym / sponsor ID
- EDIPE / 346/2023/Oss/AOUBo
- Conditions
- Preeclampsia, Hypertensive Disorder of Pregnancy
- Keywords
- Preeclampsia, Hypertensive Disorders of Pregnancy, Hypertension, Obstetric Medicine, Cardio-Obstetrics, Cardiovascular outcomes, Pregnancy complications, Arterial Stiffness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Collaborators
- University of Bologna
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Principal arm | Experimental | Device: Arterial applanation tonometry, Device: In vivo endothelial glycocalyx measurement, Diagnostic Test: Serum markers of angiogenesis and endothelial dysfunction, Diagnostic Test: Blood chemistry test, Diagnostic Test: Serum xanthine oxidase activityThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial applanation tonometryAlso: PulsePen, Arterial stiffness measurement, Pulse wave velocity assessmentArterial 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 | Principal arm |
| In vivo endothelial glycocalyx measurementAlso: Glycocheck, Sidestream dark field microscopyThe 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). | Device | Principal arm |
| Serum markers of angiogenesis and endothelial dysfunctionAlso: ANG-1, ET-1, ICAM-1, VCAM-1ELISA assays to measure serum circulating markers of angiogenesis and endothelial dysfunction (ANG-1, ANG-2, ET-1, ICAM-1 and VCAM-1). | Diagnostic test | Principal arm |
| Blood chemistry testImmunochemistry analysis of serum levels of uric acid, total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides, Lipoprotein (a) | Diagnostic test | Principal arm |
| Serum xanthine oxidase activitySerum xanthine oxidase (XO) activity will be assessed in blood samples measuring the ability of XO to produce uric acid | Diagnostic test | Principal arm |
Primary outcome
Perfused Boundary Region (PBR)
Time frame: Baseline visit (11/13+6 weeks of pregnancy)
Micron
Perfused Boundary Region (PBR)
Time frame: Follow-up visit (24/27+6 weeks of pregnancy)
Micron
Carotid-femoral pulse wave velocity (cf-PWV)
Time frame: Baseline visit (11/13+6 weeks of pregnancy)
m/s
Carotid-femoral pulse wave velocity (cf-PWV)
Time frame: Follow-up visit (24/27+6 weeks of pregnancy)
m/s
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 diagnosed during pregnancy with any hypertensive disorder of pregnancy
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
Number of participants diagnosed during pregnancy with preeclampsia according to the International Society for the Study of Hypertension in Pregnancy (ISSHP) criteria.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: Yes. All de-identified IPD that underlie results in a publication for all primary and secondary outcome measures will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cristina Scollo, BD contact
Arrigo Francesco Giuseppe Cicero, MD, PhD principal investigator
IRCCS University Hospital of Bologna, Italy. University of Bologna, Italy.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arterial applanation tonometry, In vivo endothelial glycocalyx measurement and Serum markers of angiogenesis and endothelial dysfunction in people with Preeclampsia and Hypertensive Disorder of Pregnancy, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arrigo Francesco Giuseppe Cicero, MD, PhD (+39 051 214290, arrigo.cicero@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfused Boundary Region (PBR) (time frame: Baseline visit (11/13+6 weeks of pregnancy)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.