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Clinical Trials/NCT06133621
NCT06133621
Completed
Not Applicable

Thrombophilia Assessment and Pregnancy: Determination of Reference Values for dRVVT in Pregnant Women

Hospices Civils de Lyon1 site in 1 country100 target enrollmentMarch 28, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Normal Pregnancy
Sponsor
Hospices Civils de Lyon
Enrollment
100
Locations
1
Primary Endpoint
dRVVT value during pregnancy.
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

Pregnancy is associated with significant changes in several aspects of haemostasis, especially an imbalance between procoagulant and anticoagulant factors. These changes contribute to creating a state of hypercoagulability, mainly at the end of pregnancy and during the post-partum period, protecting pregnant women from delivery haemorrhage, but exposing them to a major thromboembolic risk.

Vascular diseases of pregnancy (VDP) are obstetric diseases which are linked to an ischaemic origin associated with placental thrombosis. These include pre-eclampsia, retroplacental haematoma, intrauterine growth retardation and even foetal death in utero. A number of risk factors have been identified for these VDPs, some of which have extremely serious consequences, the main one being antiphospholipid syndrome (APS).

The diagnosis of VDP in a current or previous pregnancy requires close monitoring and joint management by an obstetrician, haemostasis physician, internist and medical biologist, particularly in terms of pre, peri- and post-partum anticoagulation in patients at increased risk of thromboembolism.

The aim of treating APS during pregnancy is : to reduce the occurrence of maternal arterial or venous thrombotic complications in one hand and in the other hand to reduce the occurrence of obstetric complications, which are responsible of a significant morbimortality rate. The detection of a possible APS during pregnancy will therefore determine the specific management of patients.

The latest guidelines from the Groupe Français d'Etude sur l'Hémostase et la Thrombose (GFHT) in 2022 recommended a diluted Russell's viper venom time (dRVVT) and an activated partial thromboplastin time (APTT) measured using a sensitive reagent such as silica (SCT) should be used to assess the presence of LA.

Detailed Description

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Registry
clinicaltrials.gov
Start Date
March 28, 2024
End Date
September 28, 2025
Last Updated
4 months ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Control group :
  • patients with normal pregnancies at the HCL.
  • Affiliation to a social security regime
  • Case group :
  • Patients followed at the HCL who had an increased dRVVT ratio during pregnancy, investigated as part of the development of VDP during pregnancy.
  • Affiliation to a social security regime

Exclusion Criteria

  • History of thromboembolic disease
  • History of autoimmune disease
  • History of VDP

Outcomes

Primary Outcomes

dRVVT value during pregnancy.

Time Frame: through study completion, an average of 9 months

Carrying out the dRVVT in the haemostasis laboratory of the Centre de Biologie et de Pathologie Est

Study Sites (1)

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