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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00695942 |
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Date of registration:
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05/06/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Prediction of the Risk of Placental Vascular Pathology and Venous Thromboembolic Disease
AngioPred |
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Scientific title:
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Prediction of the Risk of Placental Vascular Pathology and Venous Thromboembolic Disease: Role of Angiogenic Factors, Hemostasis and Uterine Artery Doppler |
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Date of first enrolment:
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June 2008 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00695942 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Céline CHAULEUR, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU de Saint-Etienne |
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Key inclusion & exclusion criteria
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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
Age minimum:
16 Years
Age maximum:
50 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Venous Thromboembolism Diseases
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Placental Vascular Pathologies
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Primary Outcome(s)
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sFlt1/plGF ratio
[Time Frame: 20, 24, 28, 32, 36 weeks]
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Secondary Outcome(s)
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SFlt1/PlGF ratio as predictive threshold to develop a PVP and/or a VTE
[Time Frame: 20, 24, 28, 32, 36 SA]
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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]
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echographic data as potential predictive factors of VTE and or PVP
[Time Frame: 22 and 32 weeks]
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thrombin generation test (TGT) as potential predictive factor risck oj PVP and VTE
[Time Frame: 20, 24, 28, 32 and 36 weeks]
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Secondary ID(s)
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0708115
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2007-A01448-45
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DGS 2008-0167
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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