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Clinical Trials/NCT01261351
NCT01261351
Completed
Not Applicable

Coagulation Activation Markers and Pre Eclampsia : Correlation With Complications

University Hospital, Lille1 site in 1 country300 target enrollmentMay 2010
ConditionsPre Eclampsia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pre Eclampsia
Sponsor
University Hospital, Lille
Enrollment
300
Locations
1
Primary Endpoint
Endogenous thrombin potential
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The primary purpose of the trial is to evaluate coagulation activator markers in patients with pre eclampsia compared to control (normal pregnancy) and to correlate these markers with the severity of the pathology.

Detailed Description

100 pre-eclamptic patients will be compared to 200 control patients (100 control matched on gestational age at inclusion and 100 control matched on delivery mode (section). Blood and urine samples will be collected at PE diagnosis, delivery and post partum. Two axes will be considered: 1. Thrombography, or kinetic measurement of thrombin generation, by studying the coagulant profile according to Hemker's method in CAT System (Calibrated Automated Thrombogram) and by thromboelastogram in ROTEM technique (delocalized coagulation analyzer), in parallel to specific activation markers (thrombin-antithrombin complex, fibrin monomers). 2. The balance of prostacyclin/thromboxane A2 by using ELISA method for urine samples and genotype-phenotype correlation (Polymorphism of prostacyclin-synthetase's promoter CYP8A1).

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
June 2014
Last Updated
11 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
University Hospital, Lille
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18 years old
  • diagnosis of pre eclampsia

Exclusion Criteria

  • multiple pregnancy
  • less than 18 year old

Outcomes

Primary Outcomes

Endogenous thrombin potential

Time Frame: at preeclampsia diagnosis

comparison of Endogenous thrombin potential between patients with Preclampsia (PE) (at the moment of the diagnosis of PE) compared to control (at the same gestational age)

Secondary Outcomes

  • In preeclampsia group : correlation between biological markers and severity of the disease(at the diagnosis of preeclampsia)
  • evolution of endogenous thrombin potential in women with preeclampsia(between the diagnosis of preeclampsia and day 2 of the post partum period)
  • genotype-phenotype correlation (Polymorphism of prostacyclin-synthetase promoter CYP8A1(at pre eclampsia diagnosis)

Study Sites (1)

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