Preeclampsia Clinical Trial
— EDIPEOfficial 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.
Status | Not yet recruiting |
Enrollment | 400 |
Est. completion date | September 2031 |
Est. primary completion date | May 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy | Bologna |
Lead Sponsor | Collaborator |
---|---|
IRCCS Azienda Ospedaliero-Universitaria di Bologna | University of Bologna |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Serum uric acid | mg/dl | Baseline visit (11/13+6 weeks of pregnancy) | |
Other | Serum uric acid | mg/dl | Follow-up visit (24/27+6 weeks of pregnancy) | |
Other | 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) | |
Other | 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) | |
Other | Xanthine Oxidase Activity | mU/mL | Baseline visit (11/13+6 weeks of pregnancy) | |
Other | Xanthine Oxidase Activity | mU/mL | Follow-up visit (24/27+6 weeks of pregnancy) | |
Primary | Perfused Boundary Region (PBR) | Micron | Baseline visit (11/13+6 weeks of pregnancy) | |
Primary | Perfused Boundary Region (PBR) | Micron | Follow-up visit (24/27+6 weeks of pregnancy) | |
Primary | Carotid-femoral pulse wave velocity (cf-PWV) | m/s | Baseline visit (11/13+6 weeks of pregnancy) | |
Primary | Carotid-femoral pulse wave velocity (cf-PWV) | m/s | Follow-up visit (24/27+6 weeks of pregnancy) | |
Primary | 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 | |
Primary | 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 | |
Secondary | Serum Angiopoietin 1 (ANG-1) | ng/ml | Baseline visit (11/13+6 weeks of pregnancy) | |
Secondary | Serum Angiopoietin 1 (ANG-1) | ng/ml | Follow-up visit (24/27+6 weeks of pregnancy) | |
Secondary | Serum Angiopoietin 2 (ANG-2) | ng/ml | Baseline visit (11/13+6 weeks of pregnancy) | |
Secondary | Serum Angiopoietin 2 (ANG-2) | ng/ml | Follow-up visit (24/27+6 weeks of pregnancy) | |
Secondary | Serum Endothelin-1 (ET-1) | Serum concentration assessed by ELISA (pg/ml) | Baseline visit (11/13+6 weeks of pregnancy) | |
Secondary | Serum Endothelin-1 (ET-1) | pg/ml | Follow-up visit (24/27+6 weeks of pregnancy) | |
Secondary | Serum Intercellular adhesion molecule-1 (ICAM-1) | ng/ml | Baseline visit (11/13+6 weeks of pregnancy) | |
Secondary | Serum Intercellular adhesion molecule-1 (ICAM-1) | ng/ml | Follow-up visit (24/27+6 weeks of pregnancy) | |
Secondary | Serum Vascular Cell Adhesion Molecule-1 (VCAM-1) | ng/ml | Baseline visit (11/13+6 weeks of pregnancy) | |
Secondary | Serum Vascular Cell Adhesion Molecule-1 (VCAM-1) | ng/ml | Follow-up visit (24/27+6 weeks of pregnancy) | |
Secondary | 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 |
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