Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-01-04 @ 4:49 PM
Study NCT ID:
NCT06194266
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2023-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supporting Women Towards Risk Reduction and Management of Gynecological and Obstetric Issues
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-09-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2023-12-18', 'studyFirstSubmitQcDate': '2024-01-05', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retrospective description of the needs and expectations of women in terms of gyneco-obstetric risk reduction', 'timeFrame': 'Through study completion, an average of 1 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nursing', 'Obstetric', 'gynecology'], 'conditions': ['Gynecologic Nursing']}, 'descriptionModule': {'briefSummary': 'The health of women who use drugs is a real public health issue where the midwife has an important role to play in the multidisciplinary support of the Center for Care, Support and Prevention in Addictology (CSAPA).\n\nThe main objective is to identify the needs and expectations of the women received in terms of reducing risks and damage at the gynecological and obstetric level.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '\\- Adult women (≥ 18 years old) followed at the Center for Care, Support and Prevention in Addictology (CSAPA) of the University Hospitals of Strasbourg', 'eligibilityCriteria': 'Eligibility Criteria:\n\n* Adult women (≥ 18 years old)\n* Followed at the Center for Care, Support and Prevention in Addictology (CSAPA) of the University Hospitals of Strasbourg\n* Speaking and understanding French\n* Agreeing to participate anonymously in this study\n\nExclusion Criteria:\n\n* Refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT06194266', 'acronym': 'SF-CSAPA', 'briefTitle': 'Supporting Women Towards Risk Reduction and Management of Gynecological and Obstetric Issues', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'How to Support Women Already Followed Within the CSAPA Towards Risk Reduction and Management of Gynecological and Obstetric Issues', 'orgStudyIdInfo': {'id': '9021'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': "Service d'Addictologie - CHU de Strasbourg - France", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}