Prediction of the Risk of Placental Vascular Pathology and Venous Thromboembolic Disease

NCT ID: NCT00695942

Last Updated: 2012-05-17

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

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-05-31

Brief Summary

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Venous thromboembolic (VTE) disease is the first cause of maternal mortality in the world. Some other pregnancy pathologies called Placental Vascular Pathologies (PVP) are linked to VTE by biological thrombophilia and are the principal cause of perinatal mortality. the identification of predictive factors of risk of occurrence or recurrence of two pathologies could enable us to propose an appropriate monitoring of patients at risk.

Detailed Description

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Main aim: To evaluate echographic, doppler and biological markers in a prospective manner as a potential predictive factor of risk of PVP and VTE.

Conditions

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Placental Vascular Pathologies Venous Thromboembolism Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

pregnancy women

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* previous history of one or more PVC episodes (preeclampsia, HELLPs, retroplacental hematoma, vascular IUGR\<10th percentile, recurrence miscarriage \>2, unexplained IUFD or IUFD after abruption placentae, eclampsia.
* Previous history of personal VTE
* Diabete (treated with diet or insulin)
* chronic hypertension
* chronic renal pathology
* lupus
* obesity
* Antihopholipids syndrome
* early and late pregnancy (\<18 years, \>38 years)
* family history of cardiovascular disease of VTE
* known biological thrombophilia without any personal past history of PVC or VTE

Exclusion Criteria

* Multiple pregnancy
* past history of in utero fetal death due to congenital malformations, rhesus incompatibility or an infection
* previous history of IUGR which etiology was a chromosomal, genic or infectious anomaly
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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ARGOS

UNKNOWN

Sponsor Role collaborator

Association de la Vallée de l'Ondaine

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Céline CHAULEUR, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

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Service d'Hématologie - CHU de Nîmes

Nîmes, , France

Site Status

Service de gynécologie Obstétrique

Nîmes, , France

Site Status

Service de Gynécologie Obstétrique - CHU Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2007-A01448-45

Identifier Type: -

Identifier Source: secondary_id

DGS 2008-0167

Identifier Type: -

Identifier Source: secondary_id

0708115

Identifier Type: -

Identifier Source: org_study_id

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