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

Completed

• Conditions: Placental Vascular Pathologies; Venous Thromboembolism Diseases

• Registration Number: NCT00695942
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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 Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-05
• Study First Submitted QC: 2008-06-10
• Study First Posted: 2008-06-12
• Status Verified: 2012-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Last Update Submitted: 2012-05-16
• Last Update Posted: 2012-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sFlt1/plGF ratio	20, 24, 28, 32, 36 weeks

Secondary Outcome Measures

Name	Time	Method
SFlt1/PlGF ratio as predictive threshold to develop a PVP and/or a VTE	20, 24, 28, 32, 36 SA
thrombin generation test (TGT) as potential predictive factor risck oj PVP and VTE	20, 24, 28, 32 and 36 weeks
echographic data as potential predictive factors of VTE and or PVP	22 and 32 weeks
sEng, rTFPI, D-Dimer, uCRP, PP13 as potential predictive factor of risk of PVP and or VTE	20, 24, 28, 32 and 36 weeks

Trial Locations

Locations (3)

Service d'Hématologie - CHU de Nîmes; 🇫🇷 Nîmes, France

Service de gynécologie Obstétrique; 🇫🇷 Nîmes, France

Service de Gynécologie Obstétrique - CHU Saint-Etienne; 🇫🇷 Saint-Etienne, France