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

This study is currently recruiting participants.
Verified November 2012 by Centre Hospitalier Universitaire de Saint Etienne
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00745212
First received: September 1, 2008
Last updated: November 22, 2012
Last verified: November 2012
History of Changes
  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 random prospective multicentric study including 2280 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.

Resource links provided by NLM:

U.S. FDA Resources

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, and/or any other pregnancy pathology requiring hospitalization and/or any complications from the antithrombotic treatment [ Time Frame: first, second or third trimester during pregnancy or post-partum ] [ Designated as safety issue: No ]

Estimated Enrollment: 2280
Study Start Date: June 2008
Estimated Study Completion Date: June 2013
Estimated 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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00745212

Contacts
Contact: Céline Chauleur, MD +33(0)477828611 celine.chauleur@chu-st-etienne.fr
Contact: Florence RANCON, CRA +33(0)477120284 florence.rancon@chu-st-etienne.fr

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

No publications provided by Centre Hospitalier Universitaire de Saint Etienne

Additional 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
Study First Received: September 1, 2008
Last Updated: November 22, 2012
Health Authority: France: Ministry of Health
France: French Data Protection Authority

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
Venous Thrombosis
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on May 21, 2013