STRATHEGE STUDY, a Prospective Multicentric Evaluation of an Antithrombotic Therapeutic Strategy in Pregnant Women - Full Text View

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 :

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.
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

Drug Information available for:

Heparin Acetylsalicylic acid

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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, 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	2280
Study Start Date:	June 2008
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	December 2010 (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	0033477828611	celine.chauleur@chu-st-etienne.fr

Locations


France
	Service de Gynécologie Obstétrique - CHU Saint-Etienne	Recruiting
	Saint-Etienne, France, 42055
	Contact: Céline Chauleur, MD 0033477828611 celine.chauleur@chu-st-etienne.fr

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Investigators


Principal Investigator:	Céline CHAULEUR, MD	CHU de Saint-Etienne

More Information

Responsible Party:	Centre Hospitalier Universitaire de Saint-Etienne ( Docteur Céline Chauleur )
Study ID Numbers:	0508080
First Received:	September 1, 2008
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00745212
Health Authority:	France: Ministry of Health

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

Study placed in the following topic categories:

Embolism and Thrombosis

Aspirin

Embolism

Vascular Diseases

Venous Thromboembolism

Heparin

Thrombosis

Thromboembolism

Calcium heparin

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Centre Hospitalier Universitaire de Saint Etienne
Information provided by:	Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:	NCT00745212