Clinical trial NCT00695942: Prediction of the Risk of Placental Vascular Pathology and Venous Thromboembolic Disease
Official title: Prediction of the Risk of Placental Vascular Pathology and Venous Thromboembolic Disease: Role of Angiogenic Factors, Hemostasis and Uterine Artery Doppler
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Placental Vascular Pathologies
Venous Thromboembolism Diseases
Keywords: preeclampsia
eclampsia
retroplacental hematoma
vascular IUGR
IUFD
VTE
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: ARGOS
name: Association de la Vallée de l'Ondaine
First posted: 2008-06-12
Enrollment: 200
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

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.

Eligibility 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

Primary outcomes:
measure: sFlt1/plGF ratio
timeFrame: 20, 24, 28, 32, 36 weeks
Secondary outcomes:
measure: SFlt1/PlGF ratio as predictive threshold to develop a PVP and/or a VTE
timeFrame: 20, 24, 28, 32, 36 SA
measure: thrombin generation test (TGT) as potential predictive factor risck oj PVP and VTE
timeFrame: 20, 24, 28, 32 and 36 weeks
measure: sEng, rTFPI, D-Dimer, uCRP, PP13 as potential predictive factor of risk of PVP and or VTE
timeFrame: 20, 24, 28, 32 and 36 weeks
measure: echographic data as potential predictive factors of VTE and or PVP
timeFrame: 22 and 32 weeks
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Service d'Hématologie - CHU de Nîmes
city: Nîmes
country: France
facility: Service de gynécologie Obstétrique
city: Saint-Etienne
country: France
facility: Service de Gynécologie Obstétrique - CHU Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Céline CHAULEUR, MD
role: PRINCIPAL_INVESTIGATOR
References: