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

NCT06133621 | Completed

• 1 other identifier: 69HCL23_1016
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Normal Pregnancy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• dRVVT value during pregnancy.

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

  through study completion, an average of 9 months

Study Arms (2)

cases

Patients treated at HCL who have had an increased dRVVT ratio during pregnancy, investigated in the context of the development of VDP during pregnancy

Other: dosage dRVVT

Controls

Patients with normal pregnancies followed at the Croix Rousse maternity hospital

Other: dosage dRVVT

Interventions

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

Controls; cases

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Selection by the gynaecologist of pregnant women at the Croix Rousse maternity hospital, who presenting a physiological pregnancy with no history of thromboembolic or autoimmune pathology or vascular disease of pregnancy

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Dr Céline BAZIN

Lyon, France

Location

MeSH Terms

Conditions

Thrombophilia; Antiphospholipid Syndrome

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Céline DR BAZIN, DR

  Laboratoire d'hémostase CBPE HCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 15, 2023
• Study Start: March 28, 2024
• Primary Completion: September 28, 2025
• Study Completion: September 28, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

FR (1)