Prediction of the Risk of Placental Vascular Pathology and Venous Thromboembolic Disease (AngioPred)

This study has been completed.
Sponsor:
Collaborators:
ARGOS
Association de la Vallée de l'Ondaine
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00695942
First received: June 5, 2008
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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.


Condition
Placental Vascular Pathologies
Venous Thromboembolism Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of the Risk of Placental Vascular Pathology and Venous Thromboembolic Disease: Role of Angiogenic Factors, Hemostasis and Uterine Artery Doppler

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • sFlt1/plGF ratio [ Time Frame: 20, 24, 28, 32, 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SFlt1/PlGF ratio as predictive threshold to develop a PVP and/or a VTE [ Time Frame: 20, 24, 28, 32, 36 SA ] [ Designated as safety issue: No ]
  • thrombin generation test (TGT) as potential predictive factor risck oj PVP and VTE [ Time Frame: 20, 24, 28, 32 and 36 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • echographic data as potential predictive factors of VTE and or PVP [ Time Frame: 22 and 32 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

plasma and serum samples


Enrollment: 200
Study Start Date: June 2008
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
pregnancy women

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

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

community sample

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695942

Locations
France
Service d'Hématologie - CHU de Nîmes
Nîmes, France, 30000
Service de gynécologie Obstétrique
Nîmes, France, 30000
Service de Gynécologie Obstétrique - CHU Saint-Etienne
Saint-Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
ARGOS
Association de la Vallée de l'Ondaine
Investigators
Principal Investigator: Céline CHAULEUR, MD CHU de Saint-Etienne
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00695942     History of Changes
Other Study ID Numbers: 0708115, 2007-A01448-45, DGS 2008-0167
Study First Received: June 5, 2008
Last Updated: May 16, 2012
Health Authority: France: Direction Générale de la Santé
France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
preeclampsia
eclampsia
retroplacental hematoma
vascular IUGR
IUFD
VTE

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on August 21, 2014