Prediction of the Risk of Placental Vascular Pathology and Venous Thromboembolic Disease - Full Text View

Prediction of the Risk of Placental Vascular Pathology and Venous Thromboembolic Disease (AngioPred)

This study is currently recruiting participants.

Verified by Centre Hospitalier Universitaire de Saint Etienne, June 2009

First Received: June 5, 2008 Last Updated: June 9, 2009 History of Changes

Sponsors and Collaborators:	Centre Hospitalier Universitaire de Saint Etienne ARGOS Association de la Vallée de l'Ondaine
Information provided by:	Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:	NCT00695942

Purpose

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.

Condition
Placental Vascular Pathologies Venous Thromboembolism Diseases

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Prediction of the Risk of Placental Vascular Pathology and Venous Thromboembolic Disease: Role of Angiogenic Factors, Hemostasis and Uterine Artery Doppler

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:

sFlt1/plGF ratio [ Time Frame: 20, 24, 28, 32, 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

SFlt1/PlGF ratio as predictive threshold to develop a PVP and/or a VTE [ Time Frame: 20, 24, 28, 32, 36 SA ] [ Designated as safety issue: No ]
thrombin generation test (TGT) as potential predictive factor risck oj PVP and VTE [ Time Frame: 20, 24, 28, 32 and 36 weeks ] [ Designated as safety issue: No ]
sEng, rTFPI, D-Dimer, uCRP, PP13 as potential predictive factor of risk of PVP and or VTE [ Time Frame: 20, 24, 28, 32 and 36 weeks ] [ Designated as safety issue: No ]
echographic data as potential predictive factors of VTE and or PVP [ Time Frame: 22 and 32 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

plasma and serum samples

Estimated Enrollment:	200
Study Start Date:	June 2008
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 pregnancy women

Detailed Description:

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

Eligibility

Ages Eligible for Study:	16 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

community sample

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695942

Contacts

Contact: Céline Chauleur, MD	+33(0)477828611	celine.chauleur@chu-st-etienne.fr
Contact: Florence RANCON, CRA	+33(0)477127788	florence.rancon@chu-st-etienne.fr

Locations

France
Service de Gynécologie Obstétrique - CHU Saint-Etienne	Recruiting
Saint-Etienne, France, 42055
Sub-Investigator: Gautier Chene, MD
Sub-Investigator: Sébastien Cochin, MD
Sub-Investigator: Emmanuelle Denis-Bellicard, MD
Sub-Investigator: Ahmad Mehdi, MD
Sub-Investigator: Marie-Noëlle Varlet, MD
Sub-Investigator: Laetitia Vulliez, MD
Principal Investigator: Céline CHAULEUR, MD
Service d'Hématologie - CHU de Nîmes	Recruiting
Nîmes, France, 30000
Contact: Jean-Christophe GRIS, MD PhD jean.christophe.gris@chu-nimes.fr
Sub-Investigator: Eric Mercier, MD
Sub-Investigator: Eva Cochery, MD
Principal Investigator: Jean-Christophe GRIS, MD PhD
Service de gynécologie Obstétrique	Recruiting
Nîmes, France, 30000
Contact: Jean-Christophe Gris, MD PhD jean.christophe.gris@chu-nimes.fr
Sub-Investigator: Joël Agenor, MD
Sub-Investigator: Denis Dupaigne, MD
Sub-Investigator: Marie-Laure Tailland, MD

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

ARGOS

Association de la Vallée de l'Ondaine

Investigators

Principal Investigator:

Céline CHAULEUR, MD

CHU de Saint-Etienne

More Information

No publications provided

Responsible Party:	Centre Hospitalier Universitaire de Saint-Etienne ( Clément CAILLAUX )
Study ID Numbers:	0708115, 2007-A01448-45, DGS 2008-0167
Study First Received:	June 5, 2008
Last Updated:	June 9, 2009
ClinicalTrials.gov Identifier:	NCT00695942 History of Changes
Health Authority:	France: Direction Générale de la Santé; France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:

preeclampsia
eclampsia
retroplacental hematoma

vascular IUGR
IUFD
VTE

Study placed in the following topic categories:

Hematoma
Embolism and Thrombosis
Eclampsia
Embolism
Vascular Diseases
Pre-Eclampsia

Angiogenesis Inducing Agents
Preeclampsia
Venous Thromboembolism
Hemostatics
Thrombosis
Thromboembolism

Additional relevant MeSH terms:

Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

Venous Thromboembolism
Thrombosis
Thromboembolism

ClinicalTrials.gov processed this record on July 06, 2009