Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2026-01-01 @ 12:09 AM
Study NCT ID:
NCT05688228
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2022-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Voluntary Interruption of Pregnancy on Women's Sexuality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 209}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2022-12-28', 'studyFirstSubmitQcDate': '2023-01-13', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with sexual dysfunction', 'timeFrame': 'Month 6', 'description': 'Sexual dysfunction is assessed using the Female Sexual Function Index (FSFI) questionnaire, which takes into account several aspects of female sexuality: desire, arousal, lubrication, orgasm, satisfaction and pain. The threshold for differentiating between patients with and without sexual dysfunction is 26.55'}], 'secondaryOutcomes': [{'measure': 'Marital status', 'timeFrame': 'Baseline', 'description': 'single, couple, married'}, {'measure': 'Number of sexual partners in the last 12 months', 'timeFrame': 'Baseline', 'description': 'Number of sexual partners via self-questionnaire : 1 ; from 2 to 5 ; from 6 to 10 ; from 11 to 15 ; from 16 to 20 ; up to 20'}, {'measure': 'Number of sexual partners in the whole life', 'timeFrame': 'Baseline', 'description': 'Number of sexual partners via self-questionnaire : 1 ; from 2 to 5 ; from 6 to 10 ; from 11 to 15 ; from 16 to 20 ; up to 20'}, {'measure': 'Number of sexual partners in the last 4 weeks', 'timeFrame': 'Baseline', 'description': 'Number of sexual partners via self-questionnaire : 0, 1, from 2 to 5, up to 5'}, {'measure': 'Frequency of sexual activity in the last month before pregnancy discovery', 'timeFrame': 'Baseline, Month 1, Month 3, Month 6', 'description': '\\< 1 /month ; from 1 from 3 /month ; 1 /week ; twice /week ; 3 or more times /week'}, {'measure': 'Existence of physical violence in the whole life', 'timeFrame': 'Baseline', 'description': 'binary variable (yes/no)'}, {'measure': 'Existence of psychological violence in the whole life', 'timeFrame': 'Baseline', 'description': 'binary variable (yes/no)'}, {'measure': 'Existence of sexual violence in the whole life', 'timeFrame': 'Baseline', 'description': 'binary variable (yes/no)'}, {'measure': "Existence of psychological symptoms before pregnancy's discovery", 'timeFrame': 'Baseline', 'description': 'asthenia, sadness, anxiety, guilt, none'}, {'measure': 'Existence of psychological symptoms in the last month', 'timeFrame': 'Month 1, Month 3, Month 6', 'description': 'asthenia, sadness, anxiety, guilt, none'}, {'measure': "Existence of sexual difficulties since pregnancy's discovery", 'timeFrame': 'Baseline', 'description': 'Decreased desire, arousal, lubrication, quantity or quality of orgasms, sexual satisfaction or relationship with the partner, appearance or increase of pain during sexual intercourse, no change in these different areas of sexuality'}, {'measure': 'Sexual activity the last month', 'timeFrame': 'Month 1, Month 3, Month 6', 'description': 'Decreased sexual activity (fear of another pregnancy, waiting to start contraception, conflict with partner after abortion, other reason), Not concerned about decreased sexual activity'}, {'measure': 'Contraception in the last month', 'timeFrame': 'Month 1, Month 3, Month 6', 'description': 'none, removal/cycles, condoms, pill, intrauterine devic, implant, ring/patch, other'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Abortion', 'Female sexuality', 'FSFI'], 'conditions': ['Abortion']}, 'descriptionModule': {'briefSummary': 'The impact on sexuality has been less studied and there is no French study on this subject and the rare studies are contradictory.\n\nThe aim of this study is to evaluate the impact of abortion (medical or surgical) on female sexuality, to look for a difference in the impact on sexuality according to the method used for the termination (medical or surgical) just after the procedure and at 1, 3 and 6 months and to look for risk factors and protective factors for the existence or occurrence of sexual dysfunction before and after abortion.', 'detailedDescription': 'The medical consequences of abortion are low. However, there is an undeniable emotional and psychological impact on these women (40-45% of anxiety-type symptoms, approximately 20% of depressive symptoms after the discovery of the pregnancy and 30% of emotional disorders, particularly anxiety, in the month following the abortion).\n\nThe impact on sexuality has been less studied and there is no French study on this subject and the rare studies are contradictory.\n\nThe aim of this study is to evaluate the impact of voluntary termination of pregnancy (medical or surgical) on female sexuality, to look for a difference in the impact on sexuality according to the method used for the termination (medical or surgical) just after the procedure and at 1, 3 and 6 months and to look for risk factors and protective factors for the existence or occurrence of sexual dysfunction before and after a termination.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women performing a medical or surgical abortion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient (≥ 18 years)\n* Patient performing a medical or surgical abortion\n* Patient with health insurance\n* No opposition to participation in the study\n\nExclusion Criteria:\n\n* Patient who does not speak French and/or is illiterate\n* Patient under legal protection\n* Patient unable to complete the study procedures (no internet connection, no smart phone or tablet)\n* Patient with diagnosed psychiatric comorbidities.'}, 'identificationModule': {'nctId': 'NCT05688228', 'acronym': 'VTOPSimpact', 'briefTitle': "Voluntary Interruption of Pregnancy on Women's Sexuality", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': "Description of the Evolution of Women's Sexuality After a Voluntary Interruption of Pregnancy", 'orgStudyIdInfo': {'id': 'CHUBX 2022/71'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Abortion', 'description': 'Adult women performing a medical or surgical abortion', 'interventionNames': ['Other: questionnaire']}], 'interventions': [{'name': 'questionnaire', 'type': 'OTHER', 'description': 'Female Sexual Function Index (FSFI) and self-administrative questionnaires on sexuality just after abortion and repeated at 1, 3 and 6 months', 'armGroupLabels': ['Abortion']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}