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 November 2011 by Centre Hospitalier Universitaire de Saint Etienne

First Received on June 5, 2008. Last Updated on November 10, 2011 History of Changes

Sponsor:	Centre Hospitalier Universitaire de Saint Etienne
Collaborators:	ARGOS Association de la Vallée de l'Ondaine
Information provided by (Responsible Party):	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:	Observational Model: Cohort Time Perspective: 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

plasma and serum samples

Estimated Enrollment:	200
Study Start Date:	June 2008
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	May 2012 (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 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
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

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
ClinicalTrials.gov Identifier:	NCT00695942 History of Changes
Other Study ID Numbers:	0708115, 2007-A01448-45, DGS 2008-0167
Study First Received:	June 5, 2008
Last Updated:	November 10, 2011
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

Additional relevant MeSH terms:

Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis

Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on February 12, 2012