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

Placental Vascular Pathologies Clinical Trial

— AngioPred  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00695942
• Other study ID #: 0708115
• Secondary ID: 2007-A01448-45DG
• Status: Completed
• Phase: N/A
• First received: June 5, 2008
• Last updated: May 16, 2012
• Start date: June 2008
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la SantéFrance: French Data Protection Authority
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Placental Vascular Pathologies
• Thromboembolism
• Venous Thromboembolism
• Venous Thromboembolism Diseases

Locations

Country	Name	City	State
France	Service d'Hématologie - CHU de Nîmes	Nîmes
France	Service de gynécologie Obstétrique	Nîmes
France	Service de Gynécologie Obstétrique - CHU Saint-Etienne	Saint-Etienne

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	ARGOS, Association de la Vallée de l'Ondaine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sFlt1/plGF ratio		20, 24, 28, 32, 36 weeks	No
Secondary	SFlt1/PlGF ratio as predictive threshold to develop a PVP and/or a VTE		20, 24, 28, 32, 36 SA	No
Secondary	thrombin generation test (TGT) as potential predictive factor risck oj PVP and VTE		20, 24, 28, 32 and 36 weeks	No
Secondary	sEng, rTFPI, D-Dimer, uCRP, PP13 as potential predictive factor of risk of PVP and or VTE		20, 24, 28, 32 and 36 weeks	No
Secondary	echographic data as potential predictive factors of VTE and or PVP		22 and 32 weeks	No