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

Tracking Information

First Received Date ^ICMJE

June 5, 2008

Last Updated Date

June 9, 2009

Start Date ^ICMJE

June 2008

Estimated Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00695942 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Prediction of the Risk of Placental Vascular Pathology and Venous Thromboembolic Disease: Role of Angiogenic Factors, Hemostasis and Uterine Artery Doppler

Brief Summary

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

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

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

Placental Vascular Pathologies
Venous Thromboembolism Diseases

Intervention ^ICMJE

Study Arms / Comparison Groups

pregnancy women

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

October 2011

Estimated Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

16 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00695942

Responsible Party

Clément CAILLAUX, Centre Hospitalier Universitaire de Saint-Etienne

Study ID Numbers ^ICMJE

0708115, 2007-A01448-45, DGS 2008-0167

Study Sponsor ^ICMJE

Centre Hospitalier Universitaire de Saint Etienne

Collaborators ^ICMJE

ARGOS
Association de la Vallée de l'Ondaine

Investigators ^ICMJE

Principal Investigator:

Céline CHAULEUR, MD

CHU de Saint-Etienne

Information Provided By

Centre Hospitalier Universitaire de Saint Etienne

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP