Primitive Immunodeficiency and Pregnancy

Primary Immune Deficiency Clinical Trial

— PREPI  

Official title:

Primitive Immunodeficiency and Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04581460
• Other study ID #: APHP200747
• Secondary ID: 2020-A01781-38
• Status: Completed
• Start date: November 30, 2020
• Est. completion date: April 25, 2022

Study information

• Verified date: July 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: April 25, 2022
• Est. primary completion date: April 25, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult woman with Hereditary Immune Deficits and entered in the reference Center for Hereditary Immune Deficits (CEREDIH, hospital Necker-Enfants Malades, Paris) register

• Patient having reported at least one pregnancy or attempted pregnancy

• Patient not opposing to participation in research

Exclusion Criteria:

• Refusal to participate of the study

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Primary Immune Deficiency
• Primary Immunodeficiency Diseases

Intervention

Other:
• Questionnaire
Questionnaire intended for patients on the course of pregnancy and postpartum, the neonatal period and contraceptive modalities.

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infectious events	Number of infectious events at any time during pregnancy and post-partum	18 months
Secondary	Infectious gynecological complications	Number of infectious gynecological complications during contraception	Up to 50 years
Secondary	Onset of pregnancy	Number of pregnancies during reproductive age period	Up to 50 years
Secondary	Pregnancy outcomes	Rate of early or late miscarriage, completed pregnancy, live birth and childbearing	Up to 9 months
Secondary	Treatments	Number of treatments aiming at preventing infections	9 months
Secondary	Screening of infections	Presence/absence of screening for infections	9 months
Secondary	Occurrence of obstetric complications	Rate of obstetric complications	9 months
Secondary	Contraception effectiveness	Number of unwanted pregnancies	Up to 50 years
Secondary	Contraception complications	Number of non-infectious complications of contraception	Up to 50 years
Secondary	Deaths and complications in the neonatal period	Number of complications during neonatal period, including death	3 months