Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
234 participants
OBSERVATIONAL
2020-01-20
2021-11-30
Brief Summary
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PE shares pathophysiologic features with recognized protein misfolding disorders and misfolded proteins are present in urine from women with PE. Misfolded proteins are potent activators of the contact system (CAS) which is involved in inflammation, coagulation and fibrinolysis.
Plasminogen activator inhibitor 2 (PAI-2) regulates important fibrinolytic processes in the placenta. The oxidative milieu characterizing PE may trigger misfolding of PAI-2 which then loose inhibitory capacity, but gain CAS-activating capacity. Thus, misfolding of PAI-2 may affect the fibrinolytic system in the placenta and compromise the modelling of the spiral arteries. Moreover, misfolded PAI-2 may contribute to the hypercoagulability and the inflammatory conditions characterizing women with PE.
The aim of the present study is i) to characterize CAS in women with PE, ii) to study the CAS-activating capacity of misfolded PAI-2 and iii) to develop and apply immunochemical methods for determination of native and misfolded PAI-2 in plasma.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Preeclamptic women
Pregnant women who is diagnosed with preeclampsia during anytime of pregnancy.
Pregnancy
Pregnancies complicated by preeclampsia
Healthy pregnant women
Pregnant women without preeclampsia. Will be matched for body mass index, gestational age and age.
No interventions assigned to this group
Interventions
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Pregnancy
Pregnancies complicated by preeclampsia
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Region of Southern Denmark
OTHER
OPEN
UNKNOWN
Lida og Oskar Nielsens Fond
UNKNOWN
Esbjerg Fonden
OTHER
Gangsted Fonden
UNKNOWN
University of Southern Denmark
OTHER
Responsible Party
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Anne Cathrine Meldgaard Godtfredsen
Principal investigator, medical doctor, phd student
Principal Investigators
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Jørgen B Gram, Professor
Role: STUDY_DIRECTOR
University of Southern Denmark
Locations
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The Unit for Thrombosis Research, University of Southern Denmark
Esbjerg, , Denmark
Countries
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References
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Godtfredsen AC, Palarasah Y, Dolleris BB, Jorgensen JS, Sidelmann JJ, Gram JB. Increased contact activated endogenous thrombin potential in pregnant women with preeclampsia. Blood Coagul Fibrinolysis. 2024 Jan 1;35(1):1-7. doi: 10.1097/MBC.0000000000001269. Epub 2023 Nov 30.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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s-20190142
Identifier Type: -
Identifier Source: org_study_id
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