Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
99 participants
OBSERVATIONAL
2020-11-30
2022-04-25
Brief Summary
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The aim the research is to study the obstetric features and outcome of patients with primary immune defects.
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Detailed Description
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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 8.6 patients per 100,000 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.
Conditions
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Study Design
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CASE_ONLY
OTHER
Study Groups
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Patients
Patients entered in the register of the reference Center for Hereditary Immune Deficits (CEREDIH), hospital Necker-Enfants Malades, Paris, and having reported at least one pregnancy or attempted pregnancy
Questionnaire
Questionnaire intended for patients on the course of pregnancy and postpartum, the neonatal period and contraceptive modalities.
Interventions
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Questionnaire
Questionnaire intended for patients on the course of pregnancy and postpartum, the neonatal period and contraceptive modalities.
Eligibility Criteria
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Inclusion Criteria
* Patient having reported at least one pregnancy or attempted pregnancy
* Patient not opposing to participation in research
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Elise Mallart
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Caroline Charlier-Woerther, MD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Nizar Mahlaoui, MD
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hôpital Necker-Enfants Malades
Paris, , France
Countries
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References
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Mallart E, Francoise U, Driessen M, Blanche S, Lortholary O, Lefort A, Caseris M, Fischer A, Mahlaoui N, Charlier C; PREPI study group. Pregnancy in primary immunodeficiency diseases: The PREPI study. J Allergy Clin Immunol. 2023 Sep;152(3):760-770. doi: 10.1016/j.jaci.2023.05.006. Epub 2023 May 18.
Other Identifiers
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2020-A01781-38
Identifier Type: OTHER
Identifier Source: secondary_id
APHP200747
Identifier Type: -
Identifier Source: org_study_id
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