Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-28 @ 2:42 AM
Study NCT ID:
NCT06449066
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2024-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Immunodeficiencies and Obstetrical Neuraxial Anaesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020802', 'term': 'Epidural Abscess'}, {'id': 'D008581', 'term': 'Meningitis'}], 'ancestors': [{'id': 'D020819', 'term': 'Perimeningeal Infections'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000038', 'term': 'Abscess'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2024-05-30', 'studyFirstSubmitQcDate': '2024-06-06', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who develop a local or systemic infection, such as an epidural abscess or meningitis, within 28 days after receiving neuraxial anesthesia during delivery', 'timeFrame': '28 days post-partum', 'description': 'Occurrence of a local or systemic infection post-neuraxial anesthesia within 28 days after delivery / Infectious complication after obstetrical neuraxial anesthesia / Epidural abscess or meningitis after neuraxial anesthesia'}], 'secondaryOutcomes': [{'measure': 'Frequency of Alternative Pain Relief Methods Utilized Due to Contraindications Linked to Primary Immunodeficiency', 'timeFrame': 'During labour', 'description': 'Use of an alternate method for pain-relief during childbirth / Use of another method of pain relief due to a contraindication linked to primary immunodeficiency'}, {'measure': 'Rate of Antibioprophylaxis Administration During Neuraxial Anesthesia', 'timeFrame': 'up to 24 hours after birth', 'description': 'Use of a antibioprophylaxis when performing neuraxial anesthesia'}, {'measure': 'Number of cases where maternity anesthetists identify contraindications to performing neuraxial anesthesia in patients with primary immunodeficiency', 'timeFrame': 'During labour', 'description': 'Possible occurrence of contraindications identified by the maternity anesthetist to the performance of neuraxial anesthesia linked to primary immunodeficiency'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary immunodeficiencies', 'Neuraxial anaesthesia', 'Obstetrical anaesthesia', 'Epidural abscess', 'Meningitis'], 'conditions': ['Infectious Complications (Epidural Abscess or Meningitis)', 'Obstetrical Neuraxial Anaesthesia']}, 'referencesModule': {'references': [{'pmid': '40226770', 'type': 'BACKGROUND', 'citation': 'Beloeuvre A, Anselem O, Tazi A, Keita-Meyer H, Mahlaoui N, Charlier C. Anesthetic management of women with primary immunodeficiencies in the obstetric setting: A French cohort study (ANEU-DIP). J Allergy Clin Immunol Glob. 2025 Jan 30;4(2):100433. doi: 10.1016/j.jacig.2025.100433. eCollection 2025 May.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate if neuraxial anesthesia (epidural or intradural anesthesia) used during childbirth is associated with more frequent infectious complications in patients with primary immunodeficiencies (PID).', 'detailedDescription': 'Neuraxial anaesthesia (epidural or intradural) is often used to alleviate pain during labour and childbirth. Although extremely efficient and safe, rare but serious infectious complications such as epidural abscess or meningitis can occur afterwards.\n\nPatients with PID tend to have a greater risk of infectious complications than the general population. With the progress of medical care in those pathologies, female patients are now giving birth more often. The use of neuraxial anaesthesia and the associated infectious complications have never been studied in this population.\n\nThe investigators intend to review the medical records of PID patients who gave birth in an APHP hospital in the last 10 years to evaluate the use of neuraxial anesthesia and the frequency of infectious complications associated with neuraxial anesthesia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female eligible patients from the CEREDIH cohort will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patient included in the CEREDIH national register\n* Aged \\> 18 years\n\nExclusion Criteria:\n\n* Refuse to participate\n* Deceased\n* Minor\n* under judicial protection\n* obstetric file not available'}, 'identificationModule': {'nctId': 'NCT06449066', 'acronym': 'ANEU-DIP', 'briefTitle': 'Primary Immunodeficiencies and Obstetrical Neuraxial Anaesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Infectious Complications Associated With the Use of Peri-partum Neuraxial Anaesthesia in Patients With Primary Immunodeficiencies', 'orgStudyIdInfo': {'id': 'APHP240481'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'CEREDIH (centre de reference des deficits immunitaires héréditaires) cohort Female patients, alive and \\> 18 years old, registered at the CEREDIH who gave birth in an APHP maternity', 'interventionNames': ['Other: Non applicable']}], 'interventions': [{'name': 'Non applicable', 'type': 'OTHER', 'description': 'Non applicable (data collection)', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Infectiology mobile team - Department of Infectious and Tropical Diseases', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Caroline Charlier-Woerther', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APHP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}