Evaluation of an Antithrombotic Therapeutic Strategy in Pregnant Women

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00745212

Acronym

STRATHEGE

Enrollment

2280

Registered

2008-09-03

Start date

2008-06-30

Completion date

2013-06-30

Last updated

2017-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placental Vascular Pathologies, Venous Thromboembolism Diseases

Keywords

venous thromboembolism diseases, placental vascular pathologies, antithrombotic treatment, symptomatic thromboembolic events, pregnant women, score, therapeutic strategies, heparin, aspirin, pregnancy pathology

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. .

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Countries

France

Outcome results