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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00745212
First received: September 1, 2008
Last updated: November 6, 2013
Last verified: November 2013
  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:


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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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 6, 2013
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 August 28, 2014