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Multiparametric Assessment of Maternal Vascular Function in the Prediction of Hypertensive Disorders of Pregnancy

Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

Last updated 4 months ago

Study ID

346/2023/Oss/AOUBo

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18 to 65 Years
Female

Trial Timing

Started 3 years ago

What is this trial about?

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.

What are the participation requirements?

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