Primitive Immunodeficiency and Pregnancy

NCT04581460 | Completed

• 2 other identifiers: APHP2007472020-A01781-38
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Immune Deficiency

Keywords

Primary immune deficiency; Obstetric experiences; Infectious complications; Pregnancy; Postpartum; Contraception

Outcome Measures

Primary Outcomes (1)

• Infectious events

  Number of infectious events at any time during pregnancy and post-partum

  18 months

Secondary Outcomes (9)

• Infectious gynecological complications

  Up to 50 years

• Onset of pregnancy

  Up to 50 years

• Pregnancy outcomes

  Up to 9 months

• Treatments

  9 months

• Screening of infections

  9 months

Study Arms (1)

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

Interventions

Questionnaire OTHER

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

Patients

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \- Refusal to participate of the study

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Related 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: 10.1016/j.jaci.2023.05.006. Epub 2023 May 18.

  PMID: 37210041 RESULT

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Elise Mallart

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Caroline Charlier-Woerther, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Nizar Mahlaoui, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: October 9, 2020
• Study Start: November 30, 2020
• Primary Completion: April 25, 2022
• Study Completion: April 25, 2022
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)