Preeclampsia and Contact Activation

Preeclampsia Clinical Trial

Official title:

Preeclampsia and Contact Activation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04825145
• Other study ID #: s-20190142
• Status: Completed
• Start date: January 20, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: November 2022
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant women developing preeclampsia

Exclusion Criteria:

• Healthy pregnant women

Related Conditions & MeSH terms

• CAS
• Misfolding Disease, Protein
• Pre-Eclampsia
• Preeclampsia

Intervention

Other:
• Pregnancy
Pregnancies complicated by preeclampsia

Locations

Country	Name	City	State
Denmark	The Unit for Thrombosis Research, University of Southern Denmark	Esbjerg

Sponsors (6)

Lead Sponsor	Collaborator
University of Southern Denmark	Esbjerg Fonden, Gangsted Fonden, Lida og Oskar Nielsens Fond, OPEN, Region of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Contact Activation System (CAS)	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,	3 years
Primary	Misfolded Plasminogen activator inhibitor 2 (PAI-2)	Biomarkers for misfolded PAI-2 in plasma Native PAI-2 antigen, Misfolded PAI-2, Native PAI-1 antigen,	3 years