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OpenTrials
Completed

NCT Number: NCT00695942

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

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.

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Key information

Conditions

Placental Vascular Pathologies Eclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases Venous Thromboembolism Diseases

Age range

16 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Service d'Hématologie - CHU de Nîmes, Nîmes, France

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About this study

Main aim: To evaluate echographic, doppler and biological markers in a prospective manner as a potential predictive factor of risk of PVP and VTE.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. sFlt1/plGF ratio

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

Secondary outcomes

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

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

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

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

  3. 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

  4. echographic data as potential predictive factors of VTE and or PVP

    Time frame: 22 and 32 weeks

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • ARGOS
  • Association de la Vallée de l'Ondaine

Registry information

Official study title

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

Acronym: AngioPred

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jun 12, 2008
Registry last updated
May 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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