Clinical trial NCT00745212: Evaluation of an Antithrombotic Therapeutic Strategy in Pregnant Women
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2008-09-03
Enrollment: 2280
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

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.

Eligibility 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

Primary outcomes:
measure: Occuring of symptomatic thromboembolic events and/or placental vascular pathology, any other pregnancy pathology requiring hospitalization, any complications from the antithrombotic treatment
timeFrame: first, second or third trimester during pregnancy or post-partum
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: Service de Gynécologie Obstétrique - CHU Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Céline CHAULEUR, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chauleur C, Gris JC, Laporte S, Rancon F, Varlet MN, Decousus H, Mismetti P; STRATHEGE Group. Use of the Delphi method to facilitate antithrombotics prescription during pregnancy. Thromb Res. 2010 Aug;126(2):88-92. doi: 10.1016/j.thromres.2010.01.012. Epub 2010 Feb 13.