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

May 16, 2012 updated by: Centre Hospitalier Universitaire de Saint Etienne

Prediction of the Risk of Placental Vascular Pathology and Venous Thromboembolic Disease: Role of Angiogenic Factors, Hemostasis and Uterine Artery Doppler

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nîmes, France, 30000
        • Service d'Hématologie - CHU de Nîmes
      • Nîmes, France, 30000
        • Service de gynécologie Obstétrique
      • Saint-Etienne, France, 42055
        • Service de Gynécologie Obstétrique - CHU Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

community sample

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
pregnancy women

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
sFlt1/plGF ratio
Time Frame: 20, 24, 28, 32, 36 weeks
20, 24, 28, 32, 36 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
SFlt1/PlGF ratio as predictive threshold to develop a PVP and/or a VTE
Time Frame: 20, 24, 28, 32, 36 SA
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
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
20, 24, 28, 32 and 36 weeks
echographic data as potential predictive factors of VTE and or PVP
Time Frame: 22 and 32 weeks
22 and 32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

ARGOS
Association de la Vallée de l'Ondaine

Investigators

  • Principal Investigator: Céline CHAULEUR, MD, CHU de Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

June 5, 2008

First Submitted That Met QC Criteria

June 10, 2008

First Posted (Estimate)

June 12, 2008

Study Record Updates

Last Update Posted (Estimate)

May 17, 2012

Last Update Submitted That Met QC Criteria

May 16, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0708115
  • 2007-A01448-45
  • DGS 2008-0167

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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