Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-02-06 @ 4:47 PM
Study NCT ID:
NCT04257318
Status:
COMPLETED
Last Update Posted:
2024-01-17
First Post:
2020-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clitoris Potential Analgesic Function Research by Pregnant Women : Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-16', 'studyFirstSubmitDate': '2020-01-29', 'studyFirstSubmitQcDate': '2020-02-04', 'lastUpdatePostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability', 'timeFrame': 'through study completion, an average of 15 months', 'description': 'Among patients who had the information visit, proportion of those who were included and applied the procedure at least twice'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'Assessment of the acceptability by pregnant women on the research of the potential analgesic function of the clitoris.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant woman, whatever the term, primiparous or multiparous\n* Age ≥ 18 years old\n* Patient having read and understood the information letter and signed the consent form\n* Patient affiliated to Social Security\n\nExclusion Criteria:\n\n* Inability to understand French or information,\n* Person deprived of their liberty by an administrative or judicial decision\n* Person placed under the protection of justice\n* Person under guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT04257318', 'acronym': 'FAC', 'briefTitle': 'Clitoris Potential Analgesic Function Research by Pregnant Women : Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Clitoris Potential Analgesic Function Research by Pregnant Women : Feasibility Study', 'orgStudyIdInfo': {'id': '2018/0415/HP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vibrating Relaxation Tool', 'description': 'Use of a Vibrating Relaxation Tool in case of pain during pregn', 'interventionNames': ['Other: Vibrating Relaxation Tool']}], 'interventions': [{'name': 'Vibrating Relaxation Tool', 'type': 'OTHER', 'description': 'Use of a Vibrating Relaxation Tool in case of pain during pregnancy', 'armGroupLabels': ['Vibrating Relaxation Tool']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rouen', 'country': 'France', 'facility': 'Rouen University Hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'Eric VERSPYCK, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Rouen'}, {'name': 'Manon BESTAUX, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Rouen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}