NCT05999851 Multiparametric Assessment of Maternal Vascular Function in the Prediction of Hypertensive Disorders of Pregnancy
| NCT ID | NCT05999851 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Preeclampsia |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2023-09-01 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
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
Contact & Investigator
Arrigo Francesco Giuseppe Cicero, MD, PhD
PRINCIPAL INVESTIGATOR
IRCCS University Hospital of Bologna, Italy. University of Bologna, Italy.
Frequently Asked Questions
Who can join the NCT05999851 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Preeclampsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05999851 currently recruiting?
Yes, NCT05999851 is actively recruiting participants. Contact the research team at arrigo.cicero@unibo.it for enrollment information.
Where is the NCT05999851 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT05999851 clinical trial?
NCT05999851 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Arrigo Francesco Giuseppe Cicero, MD, PhD at IRCCS University Hospital of Bologna, Italy. University of Bologna, Italy.. The trial plans to enroll 400 participants.