Clinical trial NCT04581460: Primitive Immunodeficiency and Pregnancy
Official title: Primitive Immunodeficiency and Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Immune Deficiency
Keywords: Primary immune deficiency
Obstetric experiences
Infectious complications
Pregnancy
Postpartum
Contraception
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 99
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients with any inherited immune defect included in the CEREDIH national cohort

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Infectious events
timeFrame: 18 months
Secondary outcomes:
measure: Infectious gynecological complications
timeFrame: Up to 50 years
measure: Onset of pregnancy
timeFrame: Up to 50 years
measure: Pregnancy outcomes
timeFrame: Up to 9 months
measure: Treatments
timeFrame: 9 months
measure: Screening of infections
timeFrame: 9 months
measure: Occurrence of obstetric complications
timeFrame: 9 months
measure: Contraception effectiveness
timeFrame: Up to 50 years
measure: Contraception complications
timeFrame: Up to 50 years
measure: Deaths and complications in the neonatal period
timeFrame: 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Elise Mallart
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Caroline Charlier-Woerther, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Nizar Mahlaoui, MD
role: STUDY_DIRECTOR
References:
citation: 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.