Study of the Transmission of Anti-interferon Type 1 Alpha Autoantibodies From Mother to Child Via the Placental Barrier

N/ANot Yet RecruitingNCT06371235

CerbaXpert250 enrolled

Overview

The main objective of the study is to evaluate the frequency of placental transfer of self-Ab directed against the mother's IFN alpha in the newborn, in all women suffering from a pathology frequently associated with the presence of these autoantibodies and in those seropositive during the pregnancy.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

250

Conditions

Woman Suffering From a Pathology Frequently Associated With the Presence of These Anti-autoantibodies Type-I Interferons

Interventions

PregiferonOTHER

This Study aims to study the transmission of anti-interferon alpha autoantibodies from mother to child viaplacental barrier

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant woman over 18 years old * Woman whose gestational age is less than 30 weeks. * Having agreed to carry out an assay of anti-IFN alpha IgG auto-Ac before 30 weeks * Give birth in the inclusion center * Suffering from a pathology frequently associated with the presence of these anti-autoantibodies IFN alpha (lupus, severe COVID-19, myasthenia gravis, incontinentia pigmenti, hypoparathyroidism, adrenal insufficiency, diffuse candidiasis, Biermer's disease, dysthyroidism, type 1 diabetes, celiac disease, auto-thyroid disease immune system such as Graves' disease, Hashimoto's thyroiditis) or knowing its positive anti-IFN alpha autoantibody status * Affiliated with the Social Security system Exclusion Criteria: * Patient who underwent a blood transfusion less than 2 months ago * Patient who received an organ transplant * Patient undergoing immunotherapy, stem cell therapy and/or other malignancy maternal, under heavy treatment (chemotherapy) less than 6 months before inclusion

Outcomes

Primary Outcomes

Frequency of placental transfer of self-Ab directed against IFN alpha from mother to newborn.

A placental transfer will be defined by the presence of anti-IFN alpha IgG auto Ab in the blood. of the umbilical cord. The transfer frequency will be calculated with its overall 95% confidence interval and by pathology (lupus, severe COVID-19, myasthenia gravis, incontinentia pigmenti, hypoparathyroidism, adrenal insufficiency, diffuse candidiasis, Biermer's disease, dysthyroidism, type 1 diabetes, celiac disease, autoimmune thyroid disease such such as Graves' disease, Hashimoto's thyroiditis), in HIV-positive women by pathology (lupus, severe COVID-19, myasthenia gravis, incontinentia pigmenti, hypoparathyroidism, adrenal insufficiency, diffuse candidiasis, Biermer's disease, dysthyroidism, type 1 diabetes, celiac disease, autoimmune thyroid disease such as Graves' disease, Hashimoto's thyroiditis), in HIV-positive women.

Time frame: 30 months

Data from ClinicalTrials.gov

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