NCT Number: NCT07513558
Preeclampsia (PE) is a serious pregnancy complication characterized by new-onset hypertension and signs of maternal organ dysfunction, often accompanied by placental abnormalities and systemic endothelial dysfunction. PE is associated with adverse maternal and perinatal outcomes and confers an increased long-term risk of cardiovascular and metabolic disease for both mother and offspring.
This prospective observational cohort study aims to establish a longitudinal pregnancy and birth cohort of women diagnosed with preeclampsia. Pregnant women with a clinical diagnosis of PE according to current obstetric guidelines will be recruited at their initial presentation either in the in- or outpatient clinic or in the delivery ward, respectively and followed through late pregnancy, delivery, and early postpartum.
Participants will undergo study visits during pregnancy, sample collection at delivery, and a postpartum visit 8-12 weeks after birth. Clinical data, physical measurements, questionnaire-based information, and biological samples will be collected from mothers and infants to enable comprehensive phenotyping of pregnancies complicated by preeclampsia.
Data and biosamples from this cohort will be used for descriptive and hypothesis-driven analyses and may be compared with data from an existing longitudinal cohort of healthy pregnancies to support interpretation of preeclampsia-associated biological and clinical changes.
Interested in participating?
Request Info18 year and older
Female
Observational
Graz, 8036, Austria
Location status: Recruiting
Christina Stern, Dr.med
PRINCIPAL_INVESTIGATOR
Evelyn Jantscher-Krenn, PhD
PRINCIPAL_INVESTIGATOR
Federica Piani, MD PhD
PRINCIPAL_INVESTIGATOR
Ursula Hiden, PhD
PRINCIPAL_INVESTIGATOR
Preeclampsia (PE) is a pregnancy-specific hypertensive disorder characterized by new-onset hypertension and signs of maternal organ dysfunction, often accompanied by placental abnormalities and systemic endothelial dysfunction. PE is associated with increased perinatal morbidity and an elevated long-term risk for cardiovascular and metabolic disease in both mothers and offspring. Despite its clinical relevance, the biological mechanisms underlying PE and its long-term consequences are not fully understood.
This prospective, monocentric observational cohort study is designed to establish a well-characterized longitudinal pregnancy and birth cohort of women diagnosed with PE. The primary objective is to collect clinical data and biological samples across pregnancy, delivery, and early postpartum to support detailed phenotyping of PE pregnancies and early-life outcomes.
Approximately 50 pregnant women with a confirmed diagnosis of PE will be recruited per year at the Department of Obstetrics and Gynecology. Eligible participants are women aged 18 years or older with an ongoing pregnancy and a clinical diagnosis of PE according to current obstetric guidelines. Women with major fetal anomalies are excluded.
Study participation includes four time points:
At each study visit, standardized clinical assessments, physical measurements, and questionnaire-based information will be collected. Maternal assessments include hemodynamic assessments, anthropometry, body composition. Fetal growth is assessed by routine obstetric ultrasound. At delivery, perinatal samples such as placenta, umbilical cord, and cord blood are collected. Postnatal assessments include maternal and infant anthropometry and selected cardiovascular measurements where applicable.
Biological samples collected longitudinally may include blood, urine, saliva, vaginal swabs, breast milk, placental tissue, umbilical cord tissue, and umbilical cord blood. Samples are processed and stored in a biobank for future analyses following separate ethical approvals. Clinical metadata include pregnancy outcomes, PE severity, treatment and management, delivery characteristics, and neonatal outcomes.
Lifestyle and behavioral factors, including nutrition and physical activity, are assessed using standardized questionnaires. Data are pseudonymized and handled in accordance with applicable data protection regulations.
This study is designed as a cohort and sample collection platform.
For contextual comparison, data and biosamples from an existing longitudinal cohort of healthy pregnancies will be used where appropriate. Alignment of visit timing and data collection procedures allows comparative analyses between PE and normotensive pregnancies.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From study enrollment after PE diagnosis through 8-12 weeks postpartum
Vicorder
Time frame: From study enrollment after PE diagnosis through 8-12 weeks postpartum
Measured as fat mass and fat-free mass by air displacement plethysmography longitudinally after gestational diabetes diagnosis and during early postpartum follow-up.
Time frame: from study enrollment after PE diagnosis through 8-12 weeks postpartum
USCOM 1A
Time frame: From study enrollment after PE diagnosis through 8-12 weeks postpartum
Assessment of inflammatory parameters in serum and plasma
Time frame: From study enrollment after PE diagnosis through 8-12 weeks postpartum
Lipid profile: triglycerides, free fatty acids, phospholipids, HDL/LDL/total cholesterol
Time frame: From study enrollment after PE diagnosis through 8-12 weeks postpartum
Retina scan
Time frame: From study enrollment after PE diagnosis through 8-12 weeks postpartum
Echocardiography
Time frame: At birth and at 8-12 weeks postpartum
Blood pressure measurement (systolic and diastolic)
Time frame: At birth and at 8-12 weeks postpartum
fat mass and fat-free mass by air displacement plethysmography (via PEAPOD)
Time frame: At birth and at 8-12 weeks postpartum
Echocardiography
Contact information is provided by the study sponsor or research team.
Christina Stern, Dr.med
CONTACT
Ursula Hiden, PhD
CONTACT
Medical University of Graz
Other
Face to Face With Preeclampsia: Understanding Its Origin, Characteristics and Effects on Mother and Baby
Acronym: GRAZ-PE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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