Study of Coagulation Activation Markers and Pre Eclampsia (PRESTIGE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01261351|
Recruitment Status : Completed
First Posted : December 16, 2010
Last Update Posted : December 18, 2014
|Condition or disease|
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:
- 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).
- 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 Type :||Observational|
|Actual Enrollment :||300 participants|
|Observational Model:||Case Control|
|Official Title:||Coagulation Activation Markers and Pre Eclampsia : Correlation With Complications|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
- 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)
- 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
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
|University Hospital of Lille|
|Lille, Nord, France, 59037|
|Principal Investigator:||Véronique Houfflin Debarge, PHD||Universituy Hospital Of Lille, France|