Study of Coagulation Activation Markers and Pre Eclampsia

Pre Eclampsia Clinical Trial

— PRESTIGE  

Official title:

Coagulation Activation Markers and Pre Eclampsia : Correlation With Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01261351
• Other study ID #: 2008_16/0921
• Secondary ID: PHRC 2009/191020
• Status: Completed
• Phase: N/A
• First received: October 26, 2010
• Last updated: December 17, 2014
• Start date: May 2010
• Est. completion date: June 2014

Study information

• Verified date: December 2014
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 18 years old

• diagnosis of pre eclampsia

Exclusion Criteria:

• multiple pregnancy

• less than 18 year old

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Eclampsia
• Pre Eclampsia
• Pre-Eclampsia

Locations

Country	Name	City	State
France	University Hospital of Lille	Lille	Nord

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endogenous thrombin potential	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)	at preeclampsia diagnosis	No
Secondary	genotype-phenotype correlation (Polymorphism of prostacyclin-synthetase promoter CYP8A1		at pre eclampsia diagnosis	No
Secondary	In preeclampsia group : correlation between biological markers and severity of the disease	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	at the diagnosis of preeclampsia	No
Secondary	evolution of endogenous thrombin potential in women with preeclampsia	Study of the evolution of endogenous thrombin potential during the time period of diagnosis of preeclampsia to day 2 of the post partum.	between the diagnosis of preeclampsia and day 2 of the post partum period	No