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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06133621
Acronym
GRAPL
Enrollment
100
Registered
2023-11-15
Start date
2024-03-28
Completion date
2025-09-28
Last updated
2026-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Pregnancy

Keywords

Pregnancy, Thrombophilia, Antiphospholipid syndrome, Vascular diseases of pregnancy, Diluted Russell viper venom time

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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Interventions

OTHERdosage dRVVT

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
dRVVT value during pregnancy.through study completion, an average of 9 monthsCarrying out the dRVVT in the haemostasis laboratory of the Centre de Biologie et de Pathologie Est

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026