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Evaluation of an Antithrombotic Therapeutic Strategy in Pregnant Women (STRATHEGE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00745212
First Posted: September 3, 2008
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
  Purpose

The venous thromboembolism is one of the first causes of maternal mortality. Until 2003, only a few recommendations were available on the optimal use of antithrombotic therapy as a preventive measure against thromboembolism in pregnant women. In this study, we propose :

  1. To gather the experts who took part in the French consensus conference and the local experts to create a score in accordance with the national and international consensus and to give some precise therapeutic strategies.
  2. To evaluate the discriminant, feasible and useful character of this new score by a prospective multicentric study including 2000 pregnant women with a risk of thromboembolism or placental vascular pathology who will benefit from therapeutic strategies defined by the new score.


Condition
Placental Vascular Pathologies Venous Thromboembolism Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Multicentric Evaluation of an Antithrombotic Therapeutic Strategy in Pregnant Women With a Risk of Thromboembolism and/or a Risk of Placental Vascular Complication, Strategy Determined With a Risk Score.

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • Occuring of symptomatic thromboembolic events and/or placental vascular pathology, any other pregnancy pathology requiring hospitalization, any complications from the antithrombotic treatment [ Time Frame: first, second or third trimester during pregnancy or post-partum ]

Enrollment: 2280
Study Start Date: June 2008
Study Completion Date: June 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:
Purpose : To create a score inspired by our first experience i.e. simple, standardized and quickly usable in day-to-day practice to individualize antithrombotics prescription to women at risk.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
community sample
Criteria

Inclusion Criteria:

  • multiparous or primiparous parturients followed in one of the participating centers
  • Presenting at least one risk factor of venous thromboembolic pathology and/or placental vascular pathology

Exclusion Criteria:

  • parturient that can't be followed
  • unknown familial or personal previous history
  • Parturient with a contraindication to use of the treatment recommended by the therapeutic strategy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00745212


Locations
France
Service de Gynécologie Obstétrique - CHU Saint-Etienne
Saint-Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Céline CHAULEUR, MD PhD CHU de Saint-Etienne
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00745212     History of Changes
Other Study ID Numbers: 0508080
First Submitted: September 1, 2008
First Posted: September 3, 2008
Last Update Posted: November 9, 2017
Last Verified: November 2017

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
venous thromboembolism diseases
placental vascular pathologies
antithrombotic treatment
symptomatic thromboembolic events
pregnant women
score
therapeutic strategies
heparin
aspirin
pregnancy pathology

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases