Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
Study NCT ID:
NCT06708208
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-27
First Post:
2024-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Requests for Voluntary Termination and Medical Termination of Pregnancy for Maternal, Psychological or Social Reasons At the Women's Center ( La Maison Des Femmes) in Saint-Denis :
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 107}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-25', 'studyFirstSubmitDate': '2024-11-25', 'studyFirstSubmitQcDate': '2024-11-25', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demographic data', 'timeFrame': '1 day', 'description': 'Age'}, {'measure': 'Demographic data', 'timeFrame': '1 day', 'description': 'Birth place'}, {'measure': 'Demographic data', 'timeFrame': '1 day', 'description': 'Migration history'}, {'measure': 'Medical history', 'timeFrame': '1 day', 'description': 'Term of abotion'}, {'measure': "Violence's history", 'timeFrame': '1 day', 'description': 'Description of the violence. Current situation of violence.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pregnancy', 'voluntary termination of pregnancy', 'violence', 'abortion', 'termination of pregnancy', 'medical abortion'], 'conditions': ['Pregnancy', 'Violence Against Women (VAW)', 'Violence', 'Abortion', 'Termination of Pregnancy', 'Voluntary Termination of Pregnancy', 'Medical Abortion']}, 'descriptionModule': {'briefSummary': 'In France, Article L2213-1 of the Public Health Code (law of July 4, 2001) clearly establishes that "voluntary termination of pregnancy may be performed at any time if two doctors, who are part of a multidisciplinary team, certify-after this team has provided its advisory opinion-that continuing the pregnancy seriously endangers the woman\'s health." Consequently, when a request for termination of pregnancy is made within the first sixteen weeks of amenorrhea, patients exercise complete autonomy in their decision-making. This process is unequivocally recognized as voluntary termination of pregnancy (VTP).\n\nIf an abortion is performed after the pregnancy has ended, the patient\'s request must undergo a multidisciplinary assessment. This procedure is known as medical termination of pregnancy for maternal indications.\n\nThere are generally two categories of indications for this procedure:\n\nOrganic reasons such as progressive cancer or severe heart disease. Psychosocial reasons: which include psychological and social factors.\n\nIn the case of medical terminations of pregnancy for psychological or social reasons, the National College of French Gynaecologists and Obstetricians (CNGOF) recommends that these requests be formally documented within the centers where patients receive care. However, there is considerable variability in how these practices are implemented across different locations. Furthermore, the existing literature reveals a significant lack of epidemiological and clinical data on the subject, highlighting the need for more comprehensive research in this area.\n\nOpened in 2016, the Maison des Femmes (Women\'s Center) in Saint-Denis houses a family planning center and a multi-professional support service for patients who have experienced violence. It provides care for many women who have sought a termination of pregnancy but have exceeded the legal time limit for abortion.\n\nA study conducted in 2021-2022, as part of a medical thesis, revealed a significantly high prevalence of violence experienced by women seeking a pregnancy termination for non-medical reasons at Delafontaine Hospital. The findings indicated that 65% of these patients had suffered from violence.\n\nTo strengthen our epidemiological findings, we propose a study comparing this group of women with another group who had an abortion during the same timeframe.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who expressed a request for an IMG for non-somatic maternal reasons', 'genderDescription': 'Women who are pregnant.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients (minors or adults) who have been seen at the Women's center (Maison des Femmes) for assistance with a request of termination of pregnancy for maternal, psychological and/or social reasons, including patients under legal protection (guardianship, curatorship) at the time of the consultation.\n* medical consultation between 01/01/2016 and 28/02/2022.\n\nExclusion Criteria:\n\n* Refusal of participation (patient or guardian)\n* Opposition to the use of data"}, 'identificationModule': {'nctId': 'NCT06708208', 'briefTitle': "Requests for Voluntary Termination and Medical Termination of Pregnancy for Maternal, Psychological or Social Reasons At the Women's Center ( La Maison Des Femmes) in Saint-Denis :", 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Saint-Denis'}, 'officialTitle': "Voluntary Termination and Medical Termination of Pregnancy for Maternal, Psychological or Social Reasons At Women's Center ( La Maison Des Femmes) in Saint-Denis", 'orgStudyIdInfo': {'id': '0057_MATER_28bis'}}, 'contactsLocationsModule': {'locations': [{'zip': '93200', 'city': 'Saint-Denis', 'state': 'Seine saint denis', 'country': 'France', 'facility': 'Maison des femmes', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Saint-Denis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}