Evaluation of an Antithrombotic Therapeutic Strategy in Pregnant Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2280 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Placental Vascular Pathologies Venous Thromboembolism Diseases

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Céline CHAULEUR, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Service de Gynécologie Obstétrique - CHU Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED

PMID: 20153880 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0508080

Identifier Type: -

Identifier Source: org_study_id