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

Recruiting

• Conditions: Normal Pregnancy
• Interventions: Other: dosage dRVVT

• 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

Arm && Interventions

Group	Intervention	Description
cases	dosage dRVVT	Patients treated at HCL who have had an increased dRVVT ratio during pregnancy, investigated in the context of the development of VDP during pregnancy
Controls	dosage dRVVT	Patients with normal pregnancies followed at the Croix Rousse maternity hospital

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