Clinical Trials Directory

Trials / Completed

CompletedNCT04825145

Preeclampsia and Contact Activation

Status
Completed
Phase
Study type
Observational
Enrollment
234 (actual)
Sponsor
University of Southern Denmark · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers

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.

Conditions

Interventions

TypeNameDescription
OTHERPregnancyPregnancies complicated by preeclampsia

Timeline

Start date
2020-01-20
Primary completion
2021-11-30
Completion
2021-11-30
First posted
2021-04-01
Last updated
2022-11-02

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT04825145. Inclusion in this directory is not an endorsement.