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Study of Coagulation Activation Markers and Pre Eclampsia (PRESTIGE)

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Lille Identifier:
First received: October 26, 2010
Last updated: December 17, 2014
Last verified: December 2014
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.

Pre Eclampsia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Coagulation Activation Markers and Pre Eclampsia : Correlation With Complications

Resource links provided by NLM:

Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • genotype-phenotype correlation (Polymorphism of prostacyclin-synthetase promoter CYP8A1 [ Time Frame: at pre eclampsia diagnosis ]
  • In preeclampsia group : correlation between biological markers and severity of the disease [ Time Frame: at the diagnosis of preeclampsia ]
    correlation of endogenous thrombin potential and rotem results with : presence or absence of severe preeclampsia presence or absence of HELLP Syndrome presence or absence of IUGR presence or absence of eclampsia

  • evolution of endogenous thrombin potential in women with preeclampsia [ Time Frame: between the diagnosis of preeclampsia and day 2 of the post partum period ]
    Study of the evolution of endogenous thrombin potential during the time period of diagnosis of preeclampsia to day 2 of the post partum.

Biospecimen Retention:   Samples With DNA
  • Maternal blood and urine
  • cord blood

Enrollment: 300
Study Start Date: May 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
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).

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pregnant women from two University hospitals in France

Inclusion Criteria:

  • 18 years old
  • diagnosis of pre eclampsia

Exclusion Criteria:

  • multiple pregnancy
  • less than 18 year old
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Please refer to this study by its identifier: NCT01261351

University Hospital of Lille
Lille, Nord, France, 59037
Sponsors and Collaborators
University Hospital, Lille
Principal Investigator: Véronique Houfflin Debarge, PHD Universituy Hospital Of Lille, France
  More Information

Responsible Party: University Hospital, Lille Identifier: NCT01261351     History of Changes
Other Study ID Numbers: 2008_16/0921
PHRC 2009/1910 ( Other Grant/Funding Number: hospital clinical research program, French health ministry )
2009-A00526-51 ( Other Identifier: ID-RCB number, AFSSAPS )
Study First Received: October 26, 2010
Last Updated: December 17, 2014

Keywords provided by University Hospital, Lille:
Pre eclampsia
Endogenous thrombin potential

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications processed this record on April 25, 2017