Combining vascular tests to predict high blood pressure in pregnancy
Multiparametric Assessment of Maternal Vascular Function as a New Diagnostic and Prognostic Tool for Hypertensive Disorders of Pregnancy and Preeclampsia - EDIPE Study
We will try combining painless vascular tests with blood and urine checks in pregnant people to see if they can predict who will develop preeclampsia or other pregnancy high blood pressure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT05999851 on ClinicalTrials.gov |
What this trial studies
This single-center prospective study will enroll people with a single pregnancy in the first trimester (11+0 to 13+6 weeks) and perform two research visits during pregnancy. At enrollment and at 24+0 to 27+6 weeks investigators will perform arterial applanation tonometry and in vivo darkfield microscopy of the endothelial glycocalyx, and collect blood and urine for metabolic, angiogenic, and endothelial marker testing. Pregnancy outcomes will be recorded at delivery and all participants will be contacted five years after delivery for long-term cardiovascular outcomes. Serum endothelial and angiogenic markers will be measured in participants who develop hypertensive disorders and in matched controls to compare differences.
Who should consider this trial
Good fit: Pregnant people aged 18 or older with a single pregnancy presenting at 11+0 to 13+6 weeks of gestation and no prior pregnancies beyond 12 weeks are ideal candidates.
Not a fit: People with multifetal pregnancies, intermediate-high genetic risk requiring invasive testing, chronic kidney failure, prior organ or stem cell transplant, or those already on antihypertensives or xanthine oxidase inhibitors are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could identify people at higher risk for preeclampsia earlier in pregnancy so they can receive closer monitoring or preventive care.
How similar studies have performed: Prior research has linked arterial stiffness and angiogenic marker patterns to preeclampsia risk, but combining tonometry with endothelial glycocalyx imaging is relatively novel and not yet proven in large studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna
- Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Arrigo Francesco Giuseppe Cicero, MD, PhD — IRCCS University Hospital of Bologna, Italy. University of Bologna, Italy.
- Study coordinator: Arrigo Francesco Giuseppe Cicero, MD, PhD
- Email: arrigo.cicero@unibo.it
- Phone: +39 051 214290
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.