Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 11:11 PM
Study NCT ID:
NCT04581460
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2020-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primitive Immunodeficiency and Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081207', 'term': 'Primary Immunodeficiency Diseases'}], 'ancestors': [{'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2020-09-21', 'studyFirstSubmitQcDate': '2020-10-05', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infectious events', 'timeFrame': '18 months', 'description': 'Number of infectious events at any time during pregnancy and post-partum'}], 'secondaryOutcomes': [{'measure': 'Infectious gynecological complications', 'timeFrame': 'Up to 50 years', 'description': 'Number of infectious gynecological complications during contraception'}, {'measure': 'Onset of pregnancy', 'timeFrame': 'Up to 50 years', 'description': 'Number of pregnancies during reproductive age period'}, {'measure': 'Pregnancy outcomes', 'timeFrame': 'Up to 9 months', 'description': 'Rate of early or late miscarriage, completed pregnancy, live birth and childbearing'}, {'measure': 'Treatments', 'timeFrame': '9 months', 'description': 'Number of treatments aiming at preventing infections'}, {'measure': 'Screening of infections', 'timeFrame': '9 months', 'description': 'Presence/absence of screening for infections'}, {'measure': 'Occurrence of obstetric complications', 'timeFrame': '9 months', 'description': 'Rate of obstetric complications'}, {'measure': 'Contraception effectiveness', 'timeFrame': 'Up to 50 years', 'description': 'Number of unwanted pregnancies'}, {'measure': 'Contraception complications', 'timeFrame': 'Up to 50 years', 'description': 'Number of non-infectious complications of contraception'}, {'measure': 'Deaths and complications in the neonatal period', 'timeFrame': '3 months', 'description': 'Number of complications during neonatal period, including death'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary immune deficiency', 'Obstetric experiences', 'Infectious complications', 'Pregnancy', 'Postpartum', 'Contraception'], 'conditions': ['Primary Immune Deficiency']}, 'referencesModule': {'references': [{'pmid': '37210041', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe aim the research is to study the obstetric features and outcome of patients with primary immune defects.', 'detailedDescription': '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.\n\nAlthough 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.\n\nThe aim the research is to study the obstetric experiences of patients with a primary immune deficiency, paying particular attention to infectious complications.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients with any inherited immune defect included in the CEREDIH national cohort', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult woman with Hereditary Immune Deficits and entered in the reference Center for Hereditary Immune Deficits (CEREDIH, hospital Necker-Enfants Malades, Paris) register\n* Patient having reported at least one pregnancy or attempted pregnancy\n* Patient not opposing to participation in research\n\nExclusion Criteria:\n\n\\- Refusal to participate of the study'}, 'identificationModule': {'nctId': 'NCT04581460', 'acronym': 'PREPI', 'briefTitle': 'Primitive Immunodeficiency and Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Primitive Immunodeficiency and Pregnancy', 'orgStudyIdInfo': {'id': 'APHP200747'}, 'secondaryIdInfos': [{'id': '2020-A01781-38', 'type': 'OTHER', 'domain': 'IDRCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': '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', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Questionnaire intended for patients on the course of pregnancy and postpartum, the neonatal period and contraceptive modalities.', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker-Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'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', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}