Study of the Transmission of Anti-interferon Type 1 Alpha Autoantibodies From Mother to Child Via the Placental Barrier (Pregiferon)
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: pregnant women
Pregnant woman over 18 years old - Woman whose gestational age is less than 30 weeks |
This Study aims to study the transmission of anti-interferon alpha autoantibodies from mother to child viaplacental barrier
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of placental transfer of self-Ab directed against IFN alpha from mother to newborn.
Time Frame: 30 months
|
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. |
30 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2024-A00739-38
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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