Preeclampsia: Origin, Characteristics and Effects on Mother and Baby

NCT07513558 | Recruiting

• 1 other identifier: 1515/2025
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preeclampsia (PE); Pregnancy

Outcome Measures

Primary Outcomes (10)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Maternal or fetal genetic abnormalities

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Medical University of Graz

Graz, 8036, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Maternal samples: serum, ccfDNA (PAXgene), urine, saliva, vaginal swabs (at the visits during gestation and 8-12 wks postpartum); Maternal/neonatal samples at delivery: maternal serum and cord blood serum; ccfDNA (PAXgene), placenta and umbilical cord tissue; amniotic fluid (C-section); colostrum (48h postpartum); human milk (8-12 weeks postpartum)

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Christina Stern, Dr.med

CONTACT

+43 316 385 86306; christina.stern@medunigraz.at

Ursula Hiden, PhD

CONTACT

+43 316 385 17837; ursula.hiden@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: April 7, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2036
• Last Updated: April 13, 2026

Record last verified: 2026-03

Locations

AU (1)