Preeclampsia and Contact Activation
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|ClinicalTrials.gov Identifier: NCT04825145|
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Preeclampsia (PE) affects approximately 5% of all pregnancies with 2,500 cases registered annually in Denmark. PE is characterized by incomplete modelling of the spiral arteries of the uterus, hypertension, inflammation, hypercoagulability and proteinuria. Neonatal complications and increased cardiovascular risk are common features of the syndrome.
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.
|Condition or disease||Intervention/treatment|
|Preeclampsia CAS Misfolding Disease, Protein||Other: Pregnancy|
|Study Type :||Observational|
|Estimated Enrollment :||226 participants|
|Official Title:||Preeclampsia and Contact Activation|
|Actual Study Start Date :||January 20, 2020|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||December 31, 2022|
Pregnant women who is diagnosed with preeclampsia during anytime of pregnancy.
Pregnancies complicated by preeclampsia
Healthy pregnant women
Pregnant women without preeclampsia. Will be matched for body mass index, gestational age and age.
- The Contact Activation System (CAS) [ Time Frame: 3 years ]Biomarkers for the CAS in plasma Coagulation factor XII antigen/activity, High molecular weight kininogen (HK), Truncated (HK), Prekallikrein antigen, kallikrein generation, C1-esterase inhibitor, alpha-2-macroglobulin, Fast form alpha-2-macroglobulin, Thrombin generation,
- Misfolded Plasminogen activator inhibitor 2 (PAI-2) [ Time Frame: 3 years ]Biomarkers for misfolded PAI-2 in plasma Native PAI-2 antigen, Misfolded PAI-2, Native PAI-1 antigen,
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04825145
|Contact: Anne Cathrine M Godtfredsenfirstname.lastname@example.org|
|Contact: Gram, Professoremail@example.com|
|The Unit for Thrombosis Research, University of Southern Denmark||Recruiting|
|Esbjerg, Denmark, 6700|
|Contact: Anne Cathrine M Godtfredsen, MD +45 26887925 firstname.lastname@example.org|
|Contact: Gram, Professor + 45 79182000 email@example.com|
|Study Director:||Jørgen B Gram, Professor||University of Southern Denmark|