PRESTIGE: Study of Coagulation Activation Markers and Pre Eclampsia

Sponsor

University Hospital, Lille (Other)

Overall Status

Completed

CT.gov ID

NCT01261351

Collaborator

(none)

300

Enrollment

Location

Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pre Eclampsia

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:

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 Design

Study Type:

Observational

Actual Enrollment :

300 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Coagulation Activation Markers and Pre Eclampsia : Correlation With Complications

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Outcome Measures

Primary Outcome Measures

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

genotype-phenotype correlation (Polymorphism of prostacyclin-synthetase promoter CYP8A1 [at pre eclampsia diagnosis]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

18 years old
diagnosis of pre eclampsia

Exclusion Criteria:

multiple pregnancy
less than 18 year old

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Lille	Lille	Nord	France	59037

Sponsors and Collaborators

University Hospital, Lille

Investigators

Principal Investigator: Véronique Houfflin Debarge, PHD, Universituy Hospital Of Lille, France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Lille

ClinicalTrials.gov Identifier:

NCT01261351

Other Study ID Numbers:

2008_16/0921
PHRC 2009/1910
2009-A00526-51

First Posted:

Dec 16, 2010

Last Update Posted:

Dec 18, 2014

Last Verified:

Dec 1, 2014

Keywords provided by University Hospital, Lille

Pre eclampsia

Endogenous thrombin potential

Additional relevant MeSH terms:

Eclampsia

Pre-Eclampsia

Study Results

No Results Posted as of Dec 18, 2014