Study of Coagulation Activation Markers and Pre Eclampsia

Completed

• Conditions: Pre Eclampsia

• Registration Number: NCT01261351
• Lead Sponsor: University Hospital, Lille

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.

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 Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-10-26
• Study First Submitted QC: 2010-12-14
• Study First Posted: 2010-12-16
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-17
• Last Update Posted: 2014-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• 18 years old
• diagnosis of pre eclampsia

Exclusion Criteria

• multiple pregnancy
• less than 18 year old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endogenous thrombin potential	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

Name	Time	Method
In preeclampsia group : correlation between biological markers and severity of the disease	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	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.
genotype-phenotype correlation (Polymorphism of prostacyclin-synthetase promoter CYP8A1	at pre eclampsia diagnosis

Trial Locations

Locations (1)

University Hospital of Lille; 🇫🇷 Lille, Nord, France