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Study of Coagulation Activation Markers and Pre Eclampsia (PRESTIGE)

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ClinicalTrials.gov Identifier: NCT01261351
Recruitment Status : Completed
First Posted : December 16, 2010
Last Update Posted : December 18, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Pre Eclampsia

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).

Study Design

Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Coagulation Activation Markers and Pre Eclampsia : Correlation With Complications
Study Start Date : May 2010
Primary Completion Date : June 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. genotype-phenotype correlation (Polymorphism of prostacyclin-synthetase promoter CYP8A1 [ Time Frame: at pre eclampsia diagnosis ]
  2. 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

  3. 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

Eligibility Criteria

Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  • 18 years old
  • diagnosis of pre eclampsia

Exclusion Criteria:

  • multiple pregnancy
  • less than 18 year old
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01261351


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

Responsible Party: University Hospital, Lille
ClinicalTrials.gov 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 )
First Posted: December 16, 2010    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: December 2014

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

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications