Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-31 @ 12:09 PM
Study NCT ID:
NCT03730467
Status:
WITHDRAWN
Last Update Posted:
2025-11-20
First Post:
2018-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Puncture Breast Abscess
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Study halted prematurely, prior to enrollment of first participant', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2018-11-02', 'studyFirstSubmitQcDate': '2018-11-02', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Continuation of breastfeeding', 'timeFrame': '1 week to 6 months after the puncture', 'description': 'Phone call to the patient'}], 'secondaryOutcomes': [{'measure': 'Etiology of the abscess', 'timeFrame': '1 week to 6 months after the puncture', 'description': 'Medical record and phone call to the patient'}, {'measure': 'Adequacy of medical care with the protocol of the Parisian Perinatal Health Network', 'timeFrame': '1 week to 6 months after the puncture', 'description': 'Medical record and phone call to the patient'}, {'measure': 'Relationship between puncture breastfeeding continuation', 'timeFrame': '1 week to 6 months after the puncture', 'description': 'Medical record and phone call to the patient'}, {'measure': 'Relationship between surgery and weaning', 'timeFrame': '1 week to 6 months after the puncture', 'description': 'Medical record and phone call to the patient'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast feeding', 'breast abscess', 'ultrasound-guide', 'puncture', 'health'], 'conditions': ['Breast Abscess']}, 'descriptionModule': {'briefSummary': 'Several breast diseases can complicate breastfeeding : 4% of women develop a mastitis and 1% develop an abscess.\n\nThe study deals with cases of breast abscess that have been treated according to a defined protocol (Parisian Perinatal Health Network), by a multidisciplinary team (center of Medical Imaging Duroc) trained in breastfeeding and ultrasound-guided punctures.\n\nThe aim of the study is to define the risk factors for the onset of a breast abscess, to evaluate the indications and methods of management of abscess by ultrasound puncture, and to provide arguments motivating the continuation of breastfeeding.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women punctured for a breast lactant abscess in the center of Medical Imaging Duroc', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nursing mothers\n* Patients referred for breast abscesses during lactation\n* Having an abscess confirmed ultrasoundly and indicating a puncture\n* Women punctured of an abscess of the breast abscess in the center of Medical Imaging Duroc\n* Not opposing the use of them given and to answer the questionnaire on the immediate and medium-term future by telephone\n* Women aged \\> 18 years old\n* Women understanding French\n* Affiliated to Social Security\n\nExclusion Criteria:\n\nNo'}, 'identificationModule': {'nctId': 'NCT03730467', 'acronym': 'PONCTABCESEIN', 'briefTitle': 'Puncture Breast Abscess', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Continuation of Breastfeeding After Management of Breast Abscesses by Ultrasound-guided Punctures', 'orgStudyIdInfo': {'id': 'APHP18022'}, 'secondaryIdInfos': [{'id': '2018-A02069-46', 'type': 'REGISTRY', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Phone call to the patient', 'type': 'BEHAVIORAL', 'description': 'Phone call to the patient'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP Hopital Necker Enfants malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Virginie Rigourd, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}