Study of Coagulation Activation Markers and Pre Eclampsia (PRESTIGE)

December 17, 2014 updated by: University Hospital, Lille

Coagulation Activation Markers and Pre Eclampsia : Correlation With Complications

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 Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Nord
      • Lille, Nord, France, 59037
        • University Hospital of Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

pregnant women from two University hospitals in France

Description

Inclusion Criteria:

  • 18 years old
  • diagnosis of pre eclampsia

Exclusion Criteria:

  • multiple pregnancy
  • less than 18 year old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endogenous thrombin potential
Time Frame: 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)
at preeclampsia diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
genotype-phenotype correlation (Polymorphism of prostacyclin-synthetase promoter CYP8A1
Time Frame: at pre eclampsia diagnosis
at pre eclampsia diagnosis
In preeclampsia group : correlation between biological markers and severity of the disease
Time Frame: 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
at the diagnosis of preeclampsia
evolution of endogenous thrombin potential in women with preeclampsia
Time Frame: 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.
between the diagnosis of preeclampsia and day 2 of the post partum period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

October 26, 2010

First Submitted That Met QC Criteria

December 14, 2010

First Posted (Estimate)

December 16, 2010

Study Record Updates

Last Update Posted (Estimate)

December 18, 2014

Last Update Submitted That Met QC Criteria

December 17, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008_16/0921
  • PHRC 2009/1910 (Other Grant/Funding Number: hospital clinical research program, French health ministry)
  • 2009-A00526-51 (Other Identifier: ID-RCB number, AFSSAPS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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