Study of Coagulation Activation Markers and Pre Eclampsia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2014-06-30

Brief Summary

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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

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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).

Conditions

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Pre Eclampsia

Keywords

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Pre eclampsia Endogenous thrombin potential

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 18 years old
* diagnosis of pre eclampsia

Exclusion Criteria

* multiple pregnancy
* less than 18 year old

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Véronique Houfflin Debarge, PHD

Role: PRINCIPAL_INVESTIGATOR

Universituy Hospital Of Lille, France

Locations

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University Hospital of Lille

Lille, Nord, France

Site Status

Countries

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France

Other Identifiers

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PHRC 2009/1910

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2009-A00526-51

Identifier Type: OTHER