Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2026-01-01 @ 5:20 AM
Study NCT ID:
NCT05471895
Status:
UNKNOWN
Last Update Posted:
2023-01-09
First Post:
2022-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Sexual Violence on the Incidence of Voluntary Termination of Pregnancy in La Réunion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-06', 'studyFirstSubmitDate': '2022-07-21', 'studyFirstSubmitQcDate': '2022-07-21', 'lastUpdatePostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of women victims of sexual abuse coming for a voluntary termination of pregnancy', 'timeFrame': 'Day 1', 'description': 'Number of patients coming for a voluntary termination of pregnancy sexually abused'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sexual Violence', 'Abortion']}, 'descriptionModule': {'briefSummary': 'According to the figures for the last three years collected from the Indian Ocean Regional Health Observatory, it appears to be about twice as many voluntary terminations of pregnancy on the island of Reunion compared with France metropolitain region.\n\nFurthermore, the overseas section in 2002, which looked at violence against women of all types in three different spheres of life (the marital sphere, the workplace and public spaces), tends to show a much higher incidence of sexual violence than in metropolitain France.\n\nThis trend seems to be confirmed by the overseas section of the VIRAGE survey started in 2018 on the island.\n\nFurthermore, data found in a qualitative study conducted in Ile de France in 2013 seems to demonstrate a more frequent use of abortion among patients who are victims of sexual violence.\n\nThus, thiçs study will consist in evaluating the impact of sexual violence on the incidence of voluntary termination of pregnancy in Reunion Island.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Each centre receives an average of 15 patients per day for pre-abortion consultations.\n\nExpectation of 7 fully completed questionnaires per day per centre, then approximately 1000 fully completed questionnaires for a total of 8 weeks.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Adult patient coming for an abortion request at the CHU SUD and NORD, at the GHER and at the CEPS for the CHOR (Reunion Island)\n\nExclusion Criteria:\n\n* Patient coming to the above-mentioned centres for a "post-abortion" consultation.\n* \\<18 years\n* Patient who does not speak French.\n* Illiterate patient.\n* Patient who has already completed the questionnaire.\n* Patient refusing to participate in the study.'}, 'identificationModule': {'nctId': 'NCT05471895', 'acronym': 'IVIIRun', 'briefTitle': 'Impact of Sexual Violence on the Incidence of Voluntary Termination of Pregnancy in La Réunion', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': "Impact Des Violences Sexuelles Sur l'Incidence Des Interruptions Volontaires de Grossesses à La Réunion/ Impact of Sexual Violence on the Incidence of Voluntary Termination of Pregnancy in La Réunion", 'orgStudyIdInfo': {'id': '2021/CHU/28'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Aïda Rakotoarinosy', 'role': 'CONTACT', 'email': 'rkt.aida@gmail.com', 'phone': '02 62 35 90 00'}, {'name': 'Laetitia BERLY, PhD', 'role': 'CONTACT', 'email': 'laetitia.berly@chu-reunion.fr', 'phone': '02.62.90.62.86'}], 'overallOfficials': [{'name': 'Véronique PERETTI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU La Réunion'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}