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Preeclampsia and Contact Activation

University of Southern Denmark (SDU) logo

University of Southern Denmark (SDU)

Status

Completed

Conditions

Misfolding Disease, Protein
Preeclampsia
CAS

Treatments

Other: Pregnancy

Study type

Observational

Funder types

Other

Identifiers

NCT04825145
s-20190142

Details and patient eligibility

About

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.

Enrollment

234 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Pregnant women developing preeclampsia

Exclusion criteria

  • Healthy pregnant women

Trial design

234 participants in 2 patient groups

Preeclamptic women
Description:
Pregnant women who is diagnosed with preeclampsia during anytime of pregnancy.
Treatment:
Other: Pregnancy
Healthy pregnant women
Description:
Pregnant women without preeclampsia. Will be matched for body mass index, gestational age and age.

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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