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RecruitingNCT07513558GRAZ-PEUpdated Apr 13, 2026

Preeclampsia: Origin, Characteristics and Effects on Mother and Baby

An observational study in Preeclampsia (PE) and Pregnancy, sponsored by Medical University of Graz. Recruiting at 1 site in Austria. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Medical University of Graz · Observational

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
18 Years and older
Sex
Female
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Study summary

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.

Read the 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.

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Conditions studied

  • Preeclampsia (PE)
  • Pregnancy

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03

In context

Pre-Eclampsia

882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.

This study's planned enrollment of 250 is above the median of 163 across 380 observational studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Maternal or fetal genetic abnormalities
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Target follow-up
12 Weeks
Patient registry
Yes
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Maternal metabolic and cardiometabolic phenotype: hemodynamic assessments 1

    Vicorder

    Time frame: From study enrollment after PE diagnosis through 8-12 weeks postpartum

  2. 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.

    Time frame: From study enrollment after PE diagnosis through 8-12 weeks postpartum

  3. Maternal metabolic and cardiometabolic phenotype: hemodynamic assessments 2

    USCOM 1A

    Time frame: from study enrollment after PE diagnosis through 8-12 weeks postpartum

  4. Maternal metabolic and cardiometabolic phenotype: Cytokine Profile

    Assessment of inflammatory parameters in serum and plasma

    Time frame: From study enrollment after PE diagnosis through 8-12 weeks postpartum

  5. Maternal metabolic and cardiometabolic phenotype: Lipid profile

    Lipid profile: triglycerides, free fatty acids, phospholipids, HDL/LDL/total cholesterol

    Time frame: From study enrollment after PE diagnosis through 8-12 weeks postpartum

  6. Maternal metabolic and cardiometabolic phenotype: hemodynamic assessments 3

    Retina scan

    Time frame: From study enrollment after PE diagnosis through 8-12 weeks postpartum

  7. Maternal metabolic and cardiometabolic phenotype: Echocardiography

    Echocardiography

    Time frame: From study enrollment after PE diagnosis through 8-12 weeks postpartum

  8. Infant outcomes: hemodynamic assessment

    Blood pressure measurement (systolic and diastolic)

    Time frame: At birth and at 8-12 weeks postpartum

  9. Infant outcomes: body composition

    fat mass and fat-free mass by air displacement plethysmography (via PEAPOD)

    Time frame: At birth and at 8-12 weeks postpartum

  10. Infant outcomes: hemodynamic assessment

    Echocardiography

    Time frame: At birth and at 8-12 weeks postpartum

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Study locations

1 of 1 sites recruiting
  • Department of Obstetrics and Gynecology, Medical University of Graz
    Graz, 8036, Austria
    • Ursula Hiden, PhD · Principal investigator
    • Christina Stern, Dr.med · Principal investigator
    • Evelyn Jantscher-Krenn, PhD · Principal investigator
    • Federica Piani, MD PhD · Principal investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07513558
Lead sponsor
Medical University of Graz
Responsible party
Sponsor
First posted
Apr 7, 2026
Start date
Mar 1, 2026
Primary completion
Mar 2031 (estimated)
Completion
Mar 2036 (estimated)
Last update
Apr 13, 2026

Study contacts

Christina Stern, Dr.med
Contact
christina.stern@medunigraz.at
+43 316 385 86306
Ursula Hiden, PhD
Contact
ursula.hiden@medunigraz.at
+43 316 385 17837

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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