NCT01261351

Study of Coagulation Activation Markers and Pre Eclampsia

Coagulation Activation Markers and Pre Eclampsia : Correlation With Complications

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Pre Eclampsia

Timeline

• Start date: 2010-05-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2010-12-16
• Last updated: 2014-12-18

Locations

1 site across 1 country: France