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

Centre Hospitalier Universitaire de Saint Etienne200 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Placental Vascular Pathologies Venous Thromboembolism Diseases

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

sFlt1/plGF ratio

Time frame: 20, 24, 28, 32, 36 weeks

Secondary Outcomes

SFlt1/PlGF ratio as predictive threshold to develop a PVP and/or a VTE

Time frame: 20, 24, 28, 32, 36 SA

thrombin generation test (TGT) as potential predictive factor risck oj PVP and VTE

Time frame: 20, 24, 28, 32 and 36 weeks

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

echographic data as potential predictive factors of VTE and or PVP

Time frame: 22 and 32 weeks

Data from ClinicalTrials.gov

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