Preeclampsia: Origin, Characteristics and Effects on Mother and Baby
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMedical University of Graz
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ongoing pregnancy with preeclampsia regardless the gestational age diagnosed for PE
Disqualifiers
Maternal or fetal genetic abnormalities
Trial population
Pregnant women diagnosed with preeclampsia who present at our clinic, either in the in- or outpatient clinic or in the delivery ward, respectively.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Maternal metabolic and cardiometabolic phenotype: hemodynamic assessments 1
Vicorder
Time frame
From study enrollment after PE diagnosis through 8-12 weeks postpartum2
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 postpartum3
Maternal metabolic and cardiometabolic phenotype: hemodynamic assessments 2
USCOM 1A
Time frame
from study enrollment after PE diagnosis through 8-12 weeks postpartum4
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 postpartumSponsors and contacts
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Source ClinicalTrials.gov