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Completed

NCT Number: NCT06133621

Determination of Reference Values for Diluted Russell's Viper Venom Time (dRVVT) Specific to Pregnant Women (GRAPL)

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Dr Céline BAZIN

Lyon, France

About this study

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Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

dosage dRVVT

Other

Blood test dRVVT assay on two tubes of blood in the haemostasis laboratory of the Center de Biologie et de Pathologie Est

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: GRAPL

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 15, 2023
Registry last updated
Jan 2, 2026

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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