Evaluation of an Antithrombotic Therapeutic Strategy in Pregnant Women

Placental Vascular Pathologies Clinical Trial

— STRATHEGE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745212
• Other study ID #: 0508080
• Status: Completed
• Phase: N/A
• First received: September 1, 2008
• Last updated: November 7, 2017
• Start date: June 2008
• Est. completion date: June 2013

Study information

• Verified date: November 2017
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2280
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Placental Vascular Pathologies
• Thromboembolism
• Venous Thromboembolism
• Venous Thromboembolism Diseases

Locations

Country	Name	City	State
France	Service de Gynécologie Obstétrique - CHU Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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