Combining vascular tests to predict high blood pressure in pregnancy
Official title: Multiparametric Assessment of Maternal Vascular Function as a New Diagnostic and Prognostic Tool for Hypertensive Disorders of Pregnancy and Preeclampsia - EDIPE Study
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT05999851 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | Women only |
| Enrollment | 400 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Status | Recruiting |
| Started | September 1, 2023 |
| Main results expected | May 2026 |
| Study ends | September 2031 |
| Registry record updated | January 22, 2026 |
| Trial ID | NCT05999851 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Endothelial Biomarkers in Pregnancy: Endothelial Extracellular Vesicles and Hypertensive Disorders
This study tests whether endothelial extracellular vesicles in the blood differ between normotensive pregnant women and those with hypertensive disorders of pregnancy.
-
Progesterone to Prevent Preeclampsia in Early Pregnancy
This trial tests whether nightly vaginal progesterone started before 12 weeks can lower the chance of preeclampsia in low-risk pregnant people.
-
Postpartum high blood pressure: trying enalapril after delivery
This study tests whether giving enalapril after delivery can help postpartum women with hypertensive disorders of pregnancy manage blood pressure.
-
Registry for women with preeclampsia and related conditions
This study is collecting health information from women with preeclampsia and related conditions to help researchers learn more about the causes and find better treatments for this serious pregnancy issue.
-
Lowering blood pressure in pregnant women with hypertensive disorders to prolong pregnancy
This study is testing if lowering blood pressure in pregnant women with high blood pressure can help them stay pregnant longer and improve outcomes for both mom and baby.
-
Predicting Adverse Pregnancy Outcomes in Uganda through Partnerships and Innovation
This study tests whether everyday health data, ultrasound, and blood samples from first-time pregnant women in Uganda can help predict problems like preeclampsia, fetal growth restriction, and preterm birth.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.