Preeclampsia (PE)GRAZ-PENCT07513558
Preeclampsia: Origin, Characteristics and Effects on Mother and Baby
An observational study of Preeclampsia (PE) and Pregnancy, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia (PE), Pregnancy
- How many people
- 250 participants
- Where
- 1 siteAustria
- Study dates
- 1 Mar 2026to Mar 2036
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Ongoing pregnancy with preeclampsia regardless the gestational age diagnosed for PE
Who cannot join
- Maternal or fetal genetic abnormalities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Medical University of Graz
Graz, 8036
Ursula Hiden, PhD
Christina Stern, Dr.med
About this study
Official title: 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.
Read more
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:
- optional: a visit following PE diagnosis,
- optional: a late pregnancy visit,
- sample and clinical data collection at delivery, and
- 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.
- Conditions
- Preeclampsia (PE), Pregnancy
- Medical subject headings
- Pre-Eclampsia
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal metabolic and cardiometabolic phenotype: hemodynamic assessments 1
Vicorder
Measured: 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.
Measured: From study enrollment after PE diagnosis through 8-12 weeks postpartum
Maternal metabolic and cardiometabolic phenotype: hemodynamic assessments 2
USCOM 1A
Measured: 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
Measured: 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
Measured: From study enrollment after PE diagnosis through 8-12 weeks postpartum
Maternal metabolic and cardiometabolic phenotype: hemodynamic assessments 3
Retina scan
Measured: From study enrollment after PE diagnosis through 8-12 weeks postpartum
Maternal metabolic and cardiometabolic phenotype: Echocardiography
Echocardiography
Measured: From study enrollment after PE diagnosis through 8-12 weeks postpartum
Infant outcomes: hemodynamic assessment
Blood pressure measurement (systolic and diastolic)
Measured: At birth and at 8-12 weeks postpartum
Infant outcomes: body composition
fat mass and fat-free mass by air displacement plethysmography (via PEAPOD)
Measured: At birth and at 8-12 weeks postpartum
Infant outcomes: hemodynamic assessment
Echocardiography
Measured: At birth and at 8-12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Mar 2026
- Primary completionMar 2031 (estimated)
- Study completionMar 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preeclampsia (PE)Studies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513558
- Sponsor's protocol ID
- 1515/2025
- Acronym
- GRAZ-PE
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Face to Face With Preeclampsia: Understanding Its Origin, Characteristics and Effects on Mother and Baby
- ClinicalTrials.gov ID
- NCT07513558
- Acronym / sponsor ID
- GRAZ-PE / 1515/2025
- Conditions
- Preeclampsia (PE), Pregnancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Mar 2036 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- optional: a visit following PE diagnosis,
- optional: a late pregnancy visit,
- sample and clinical data collection at delivery, and
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Ongoing pregnancy with preeclampsia regardless the gestational age diagnosed for PE
Key exclusion criteria (1 listed)
- Maternal or fetal genetic abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maternal metabolic and cardiometabolic phenotype: hemodynamic assessments 1
Time frame: From study enrollment after PE diagnosis through 8-12 weeks postpartum
Vicorder
Maternal metabolic and cardiometabolic phenotype: Adiposity
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.
Maternal metabolic and cardiometabolic phenotype: hemodynamic assessments 2
Time frame: from study enrollment after PE diagnosis through 8-12 weeks postpartum
USCOM 1A
Maternal metabolic and cardiometabolic phenotype: Cytokine Profile
Time frame: From study enrollment after PE diagnosis through 8-12 weeks postpartum
Assessment of inflammatory parameters in serum and plasma
Maternal metabolic and cardiometabolic phenotype: Lipid profile
Time frame: From study enrollment after PE diagnosis through 8-12 weeks postpartum
Lipid profile: triglycerides, free fatty acids, phospholipids, HDL/LDL/total cholesterol
Maternal metabolic and cardiometabolic phenotype: hemodynamic assessments 3
Time frame: From study enrollment after PE diagnosis through 8-12 weeks postpartum
Retina scan
Maternal metabolic and cardiometabolic phenotype: Echocardiography
Time frame: From study enrollment after PE diagnosis through 8-12 weeks postpartum
Echocardiography
Infant outcomes: hemodynamic assessment
Time frame: At birth and at 8-12 weeks postpartum
Blood pressure measurement (systolic and diastolic)
Infant outcomes: body composition
Time frame: At birth and at 8-12 weeks postpartum
fat mass and fat-free mass by air displacement plethysmography (via PEAPOD)
Infant outcomes: hemodynamic assessment
Time frame: At birth and at 8-12 weeks postpartum
Echocardiography
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Preeclampsia (PE)
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
RecruitingPhase 2
Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
Preeclampsia (PE), Intrauterine Growth Restriction (IUGR)
Active, not recruitingObservational study
Validation of the MaiRa Preeclampsia Test for Screening Early/Late Preeclampsia in First and Second Trimesters
Preeclampsia (PE)
RecruitingObservational study
Retinal and Choroidal Microcirculation in Preeclampsia: An OCTA Study
Preeclampsia (PE), Hypertension ,Pregnancy
Not yet recruiting
Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities
Preterm Birth Complication, Preterm Birth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia (PE) and Pregnancy, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Stern, Dr.med (+43 316 385 86306, christina.stern@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal metabolic and cardiometabolic phenotype: hemodynamic assessments 1 (time frame: From study enrollment after PE diagnosis through 8-12 weeks postpartum). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.