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

Recruiting

• Conditions: Normal Pregnancy

• Registration Number: NCT06133621
• Lead Sponsor: Hospices Civils de Lyon

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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Study Timeline

• Study First Submitted: 2023-11-10
• Study First Submitted QC: 2023-11-14
• Study First Posted: 2023-11-15
• Study Start: 2024-03-28
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10
• Primary Completion: 2024-09-28
• Study Completion: 2024-09-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
dRVVT value during pregnancy.	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

Trial Locations

Locations (1)

Dr Céline BAZIN; 🇫🇷 Lyon, France