Evaluation of an Antithrombotic Therapeutic Strategy in Pregnant Women

Completed

• Conditions: Placental Vascular Pathologies; Venous Thromboembolism Diseases

• Registration Number: NCT00745212
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

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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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-09-01
• Study First Submitted QC: 2008-09-02
• Study First Posted: 2008-09-03
• Primary Completion: 2012-12
• Study Completion: 2013-06
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-07
• Last Update Posted: 2017-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2280

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occuring of symptomatic thromboembolic events and/or placental vascular pathology, any other pregnancy pathology requiring hospitalization, any complications from the antithrombotic treatment	first, second or third trimester during pregnancy or post-partum

Trial Locations

Locations (1)

Service de Gynécologie Obstétrique - CHU Saint-Etienne; 🇫🇷 Saint-Etienne, France