Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT04353856
Status:
COMPLETED
Last Update Posted:
2022-07-25
First Post:
2020-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quality of Life During a Twin Pregnancy
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': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-22', 'studyFirstSubmitDate': '2020-04-16', 'studyFirstSubmitQcDate': '2020-04-16', 'lastUpdatePostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life EQ5D questionnaire', 'timeFrame': 'Month 3', 'description': 'Quality of life score established by the EQ5D questionnaire (EUROQOL EQ-5D-3L).\n\nThe EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.'}, {'measure': 'Quality of life EQ5D questionnaire', 'timeFrame': 'Month 4', 'description': 'Quality of life score established by the EQ5D questionnaire (EUROQOL EQ-5D-3L)\n\nThe EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.'}, {'measure': 'Quality of life EQ5D questionnaire', 'timeFrame': 'Month 5', 'description': 'Quality of life score established by the EQ5D questionnaire (EUROQOL EQ-5D-3L)\n\nThe EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.'}, {'measure': 'Quality of life EQ5D questionnaire', 'timeFrame': 'Month 6', 'description': 'Quality of life score established by the EQ5D questionnaire (EUROQOL EQ-5D-3L)\n\nThe EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.'}, {'measure': 'Quality of life EQ5D questionnaire', 'timeFrame': 'Month 7', 'description': 'Quality of life score established by the EQ5D questionnaire (EUROQOL EQ-5D-3L)\n\nThe EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.'}, {'measure': 'Quality of life EQ5D questionnaire', 'timeFrame': 'Month 8', 'description': 'Quality of life score established by the EQ5D questionnaire (EUROQOL EQ-5D-3L)\n\nThe EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.'}, {'measure': 'Quality of life EQ5D questionnaire', 'timeFrame': 'Month 9', 'description': 'Quality of life score established by the EQ5D questionnaire (EUROQOL EQ-5D-3L)\n\nThe EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Twin Pregnancy']}, 'descriptionModule': {'briefSummary': 'Quality of life has recently appeared as a component of health. Pregnancy has an impact on the quality of life of the parturient, whether through physical or psychological changes.\n\nIt is common to think that quality of life is altered in the context of a twin pregnancy, but this has never been scientifically demonstrated.\n\nThe hypothesis is to observe a decrease in the quality of life of pregnant women with twins at the end of pregnancy, in particular in case of a pregnancy-related pathology.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'women over 18 years old, followed for a twin pregnancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* woman over 18\n* ongoing twin pregnancy (2 live fetuses)\n* pregnancy \\<15 weeks (weeks of gestation) completed\n* patient with follow-up at the Hôpital Femme Mère Enfant\n* person having expressed her non-opposition\n\nExclusion Criteria:\n\n* inability to understand the information given and the questionnaire\n* person deprived of liberty, under guardianship'}, 'identificationModule': {'nctId': 'NCT04353856', 'acronym': 'QUALIGEM', 'briefTitle': 'Quality of Life During a Twin Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Evolution of the Quality of Life During a Twin Pregnancy', 'orgStudyIdInfo': {'id': '69HCL20_0138'}, 'secondaryIdInfos': [{'id': 'ID-RCB', 'type': 'OTHER', 'domain': '2020-A00385-34'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'twin pregnancy', 'description': 'Women followed for a twin pregnancy', 'interventionNames': ['Other: quality of life assessment']}], 'interventions': [{'name': 'quality of life assessment', 'type': 'OTHER', 'description': 'quality of life assessment using the EQ5D questionnaire once a month', 'armGroupLabels': ['twin pregnancy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'country': 'France', 'facility': 'Hôpital Femme Mère Enfant', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}