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

Civil Hospices of Lyon

Status: Enrolling

Conditions: Normal Pregnancy

Treatments: Other: dosage dRVVT

Study type: Observational

Funder types: Other

Identifiers

NCT06133621

69HCL23_1016

Details and patient eligibility

About

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.

Full description

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Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

cases

Description:

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

Treatment:

Other: dosage dRVVT

Controls

Description:

Patients with normal pregnancies followed at the Croix Rousse maternity hospital

Treatment:

Other: dosage dRVVT