Primitive Immunodeficiency and Pregnancy (PREPI)

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.

Study Overview

• Status: Completed
• Conditions: Primary Immune Deficiency
• Intervention / Treatment: Other: Questionnaire

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.

• Study Type: Observational
• Enrollment (Actual): 99

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hopital Necker-Enfants Malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Female patients with any inherited immune defect included in the CEREDIH national cohort

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Questionnaire; Questionnaire intended for patients on the course of pregnancy and postpartum, the neonatal period and contraceptive modalities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infectious events	Number of infectious events at any time during pregnancy and post-partum	18 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Elise Mallart, Assistance Publique - Hôpitaux de Paris; Principal Investigator: Caroline Charlier-Woerther, MD, Assistance Publique - Hôpitaux de Paris; Study Director: Nizar Mahlaoui, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2020
• Primary Completion (Actual): April 25, 2022
• Study Completion (Actual): April 25, 2022

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Pregnancy; Contraception; Postpartum; Infectious complications; Primary immune deficiency; Obstetric experiences
• Additional Relevant MeSH Terms: Immune System Diseases; Genetic Diseases, Inborn; Immunologic Deficiency Syndromes; Primary Immunodeficiency Diseases
• Other Study ID Numbers: APHP200747; 2020-A01781-38 (Other Identifier: IDRCB number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No