Multiparametric Assessment of Maternal Vascular Function as a New Diagnostic and Prognostic Tool for Hypertensive Disorders of Pregnancy and Preeclampsia - EDIPE Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Italy
Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy
RECRUITING
Bologna
Contact Information
Primary
Arrigo Francesco Giuseppe Cicero, MD, PhD
arrigo.cicero@unibo.it
+39 051 214290
Backup
Cristina Scollo, BD
cristina.scollo@aosp.bo.it
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2031-09
Participants
Target number of participants: 400
Treatments
Experimental: Principal arm
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.
Related Therapeutic Areas
Sponsors
Leads: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators: University of Bologna

This content was sourced from clinicaltrials.gov