Preeclampsia: Origin, Characteristics and Effects on Mother and Baby (GRAZ-PE)

Face to Face With Preeclampsia: Understanding Its Origin, Characteristics and Effects on Mother and Baby

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Preeclampsia (PE)

Detailed Description

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:

1. optional: a visit following PE diagnosis,
2. optional: a late pregnancy visit,
3. sample and clinical data collection at delivery, and
4. a postpartum follow-up visit 8-12 weeks after birth.

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Christina Stern, Dr.med; Phone Number: +43 316 385 86306; Email: christina.stern@medunigraz.at
• Study Contact Backup: Name: Ursula Hiden, PhD; Phone Number: +43 316 385 17837; Email: ursula.hiden@medunigraz.at

Study Locations

• Austria
  • Graz, Austria, 8036
    • Recruiting
    • Department of Obstetrics and Gynecology, Medical University of Graz
    • Principal Investigator: Evelyn Jantscher-Krenn, PhD
    • Principal Investigator: Ursula Hiden, PhD
    • Principal Investigator: Christina Stern, Dr.med
    • Principal Investigator: Federica Piani, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Pregnant women diagnosed with preeclampsia who present at our clinic, either in the in- or outpatient clinic or in the delivery ward, respectively.

Description

Inclusion Criteria:

• Ongoing pregnancy with preeclampsia regardless the gestational age diagnosed for PE

Exclusion Criteria:

• Maternal or fetal genetic abnormalities

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal metabolic and cardiometabolic phenotype: hemodynamic assessments 1	Vicorder	From study enrollment after PE diagnosis through 8-12 weeks postpartum
Maternal metabolic and cardiometabolic phenotype: Adiposity	Measured as fat mass and fat-free mass by air displacement plethysmography longitudinally after gestational diabetes diagnosis and during early postpartum follow-up.	From study enrollment after PE diagnosis through 8-12 weeks postpartum
Maternal metabolic and cardiometabolic phenotype: hemodynamic assessments 2	USCOM 1A	from study enrollment after PE diagnosis through 8-12 weeks postpartum
Maternal metabolic and cardiometabolic phenotype: Cytokine Profile	Assessment of inflammatory parameters in serum and plasma	From study enrollment after PE diagnosis through 8-12 weeks postpartum
Maternal metabolic and cardiometabolic phenotype: Lipid profile	Lipid profile: triglycerides, free fatty acids, phospholipids, HDL/LDL/total cholesterol	From study enrollment after PE diagnosis through 8-12 weeks postpartum
Maternal metabolic and cardiometabolic phenotype: hemodynamic assessments 3	Retina scan	From study enrollment after PE diagnosis through 8-12 weeks postpartum
Maternal metabolic and cardiometabolic phenotype: Echocardiography	Echocardiography	From study enrollment after PE diagnosis through 8-12 weeks postpartum
Infant outcomes: hemodynamic assessment	Blood pressure measurement (systolic and diastolic)	At birth and at 8-12 weeks postpartum
Infant outcomes: body composition	fat mass and fat-free mass by air displacement plethysmography (via PEAPOD)	At birth and at 8-12 weeks postpartum
Infant outcomes: hemodynamic assessment	Echocardiography	At birth and at 8-12 weeks postpartum

Collaborators and Investigators

• Sponsor: Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2036

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: 1515/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No