Viewing Study NCT04581460



Ignite Creation Date: 2024-05-06 @ 3:18 PM
Last Modification Date: 2024-10-26 @ 1:46 PM
Study NCT ID: NCT04581460
Status: COMPLETED
Last Update Posted: 2023-11-29
First Post: 2020-09-21

Brief Title: Primitive Immunodeficiency and Pregnancy
Sponsor: Assistance Publique - Hôpitaux de Paris
Organization: Assistance Publique - Hôpitaux de Paris

Study Overview

Official Title: Primitive Immunodeficiency and Pregnancy
Status: COMPLETED
Status Verified Date: 2022-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PREPI
Brief Summary: The management of patients with primary immune deficiency is increasingly codified however contraception and pregnancy have not yet extensively studied or codified and the medical monitoring and the prevention of infectious complications thus remains at the discretion of the practitioner

The aim the research is to study the obstetric features and outcome of patients with primary immune defects
Detailed Description: Primary immune deficiencies constitute a large group of immune system disorders of genetic origin which can associate to varying degrees an increased susceptibility to infections and immunopathological manifestations allergy inflammation autoimmunity lymphoproliferation tumors malignant

Although their prevalence remains underestimated there has been an increase in the number of cases diagnosed in the past 10 years The national average prevalence is 86 patients per 100000 inhabitants and the diagnostic incidence is 400 new cases per year in France Major improvement in the management of primary immunodeficiencies have drastically changed patients outcome Most patients now reach adulthood and the possibility of carrying out a pregnancy project that has already reported for patients suffering from hypogammaglobulinemia or variable common immune deficiency is now increasingly reported for other types of inherited immunodeficiencies Whereas the management of patients with hereditary immunodeficiencies is increasingly codified contraception and pregnancy have not yet been the subject of recommendations medical monitoring and the prevention of infectious complications thus remain at the discretion of the practitioner

The aim the research is to study the obstetric experiences of patients with a primary immune deficiency paying particular attention to infectious complications

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
2020-A01781-38 OTHER IDRCB number None