Study of Coagulation Activation Markers and Pre Eclampsia (PRESTIGE)
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Coagulation Activation Markers and Pre Eclampsia : Correlation With Complications|
- Endogenous thrombin potential [ Time Frame: at preeclampsia diagnosis ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- In preeclampsia group : correlation between biological markers and severity of the disease [ Time Frame: at the diagnosis of preeclampsia ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
|Study Start Date:||May 2010|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261351
|University Hospital of Lille|
|Lille, Nord, France, 59037|
|Principal Investigator:||Véronique Houfflin Debarge, PHD||Universituy Hospital Of Lille, France|