Multiparametric Assessment of Maternal Vascular Function in the Prediction of Hypertensive Disorders of Pregnancy
Recruiting now · Not applicable
Conditions studied: Preeclampsia, Hypertensive Disorder of Pregnancy
In brief
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.
Key facts
- Study ID
- NCT05999851
- Run by
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- People needed
- 400
- Starts
- 2023-09-01
- Expected to finish
- 2031-09-01
- Last updated by the study team
- 2026-01-22
Who can join
Age: 18 and older, up to 65. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy — Bologna, Italy (enrolling)
Full record on ClinicalTrials.gov
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