Comparison of Serological Test s for the Virus Chicken Pox Virus (VZV) and Correlation With the Patient's Memory of the Infection or Vaccination

Not Applicable

Terminated

• Conditions: Pregnancy
• Interventions: Biological: Serological Test s for the Virus Chicken Pox Virus

• Registration Number: NCT02775422
• Lead Sponsor: Hopital Foch

Brief Summary

Comparison of the sensibility and specificity of 3 different serological tests and evaluation of chicken pox immunity in pregnant women.

Secondary goals :

* Correlation memory / Immunity;

* Prevalence of VZV immunity in pregnant women;

* Evaluation of cellular and humoral immunity in cases with discrepancy between tests or between test and memory;

* Evaluation of acceptability of vaccination in the post partum period in non immune patients.

Methods Not randomized prospective study,

Number of patients : 400 Duration : 36 months Inclusion criteria : pregnant women \>18years old, agree to participate (written consent) Exclusion criteria: auto immune disease, HIV +, grafted patients

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-30
• Study First Submitted: 2016-05-12
• Study First Submitted QC: 2016-05-16
• Study First Posted: 2016-05-17
• Status Verified: 2019-08
• Primary Completion: 2020-07-26
• Study Completion: 2020-07-26
• Last Update Submitted: 2020-08-21
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 308

Inclusion Criteria

• Pregnant women aged over 18
• Affiliated to a social protection scheme or women benefiting from such a regime
• Women who gived a writing consent

Read More

Exclusion Criteria

• Women with a maternal disease: autoimmune disease (systemic lupus erythematosus, antiphospholipid syndrome, insulin dependent diabetes, autoimmune thyroiditis ..), it takes an immunosuppressive treatment or not.
• HIV-positive women
• Garfted women whatever organ

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pregnant women	Serological Test s for the Virus Chicken Pox Virus	Pregnant women

Primary Outcome Measures

Name	Time	Method
Rate sensitivity and specificity in negative and dubious zone for the assessment of the serology of anti VZV immunity	35 weeks

Secondary Outcome Measures

Name	Time	Method
frequency of immunity detecting depending on whether the patient remember having varicella, have been in contact with next of kin with varicella or been vaccinated against varicella or not	up to 35 weeks
Percentage of women accepting the vaccination in case of negative history	day during the first visit

Trial Locations

Locations (1)

Hopital Foch; 🇫🇷 Suresnes, France