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Completed

NCT Number: NCT01261351

Study of Coagulation Activation Markers and Pre Eclampsia

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.

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Key information

Conditions

Pre Eclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital of Lille

Lille, Nord, 59037, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years old
  • diagnosis of pre eclampsia

Exclusion criteria

  • multiple pregnancy
  • less than 18 year old

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. genotype-phenotype correlation (Polymorphism of prostacyclin-synthetase promoter CYP8A1

    Time frame: at pre eclampsia diagnosis

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Coagulation Activation Markers and Pre Eclampsia : Correlation With Complications

Acronym: PRESTIGE

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 16, 2010
Registry last updated
Dec 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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