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Preeclampsia and Contact Activation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04825145
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Region of Southern Denmark
Lida og Oskar Nielsens Fond
Esbjerg Fonden
Gangsted Fonden
Information provided by (Responsible Party):
Anne Cathrine Meldgaard Godtfredsen, University of Southern Denmark

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 226 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Preeclamptic women
Pregnant women who is diagnosed with preeclampsia during anytime of pregnancy.
Other: Pregnancy
Pregnancies complicated by preeclampsia

Healthy pregnant women
Pregnant women without preeclampsia. Will be matched for body mass index, gestational age and age.

Primary Outcome Measures :
  1. 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,

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Probability Sample
Study Population
Preeclamptic women anytime of pregnancy compared to healthy pregnant women (control) at the same gestational age, with matching BMI and age.

Inclusion Criteria:

  • Pregnant women developing preeclampsia

Exclusion Criteria:

  • Healthy pregnant women

Information from the National Library of Medicine

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 identifier (NCT number): NCT04825145

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Contact: Anne Cathrine M Godtfredsen +4526887925
Contact: Gram, Professor +4579182000

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The Unit for Thrombosis Research, University of Southern Denmark Recruiting
Esbjerg, Denmark, 6700
Contact: Anne Cathrine M Godtfredsen, MD    +45 26887925   
Contact: Gram, Professor    + 45 79182000   
Sponsors and Collaborators
University of Southern Denmark
Region of Southern Denmark
Lida og Oskar Nielsens Fond
Esbjerg Fonden
Gangsted Fonden
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Study Director: Jørgen B Gram, Professor University of Southern Denmark
  Study Documents (Full-Text)

Documents provided by Anne Cathrine Meldgaard Godtfredsen, University of Southern Denmark:
Study Protocol  [PDF] January 1, 2020

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Responsible Party: Anne Cathrine Meldgaard Godtfredsen, Principal investigator, medical doctor, phd student, University of Southern Denmark Identifier: NCT04825145    
Other Study ID Numbers: s-20190142
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Anne Cathrine Meldgaard Godtfredsen, University of Southern Denmark:
Contact activation system, PAI-2
Additional relevant MeSH terms:
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Proteostasis Deficiencies
Hypertension, Pregnancy-Induced
Pregnancy Complications
Metabolic Diseases