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Completed

NCT Number: NCT00745212

Evaluation of an Antithrombotic Therapeutic Strategy in Pregnant Women

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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Key information

Conditions

Placental Vascular Pathologies Venous Thromboembolism Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Service de Gynécologie Obstétrique - CHU Saint-Etienne

Saint-Etienne, 42055, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Occuring of symptomatic thromboembolic events and/or placental vascular pathology, any other pregnancy pathology requiring hospitalization, any complications from the antithrombotic treatment

    Time frame: first, second or third trimester during pregnancy or post-partum

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study 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.

Acronym: STRATHEGE

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Sep 3, 2008
Registry last updated
Nov 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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