Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT06871618
Status:
COMPLETED
Last Update Posted:
2025-03-12
First Post:
2025-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrospective Study of Surgical Induced Abortions Between 14 and 16 Weeks of Amenorrhea At Croix Rousse University Hospital in Lyon
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012189', 'term': 'Retrospective Studies'}], 'ancestors': [{'id': 'D016022', 'term': 'Case-Control Studies'}, {'id': 'D016021', 'term': 'Epidemiologic Studies'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D015331', 'term': 'Cohort Studies'}, {'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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2025-03-06', 'studyFirstSubmitQcDate': '2025-03-06', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with intraoperative bleeding > 500 mL', 'timeFrame': 'Primary endpoint is measured during the intervention by collecting the total blood quantity collected into a reservoir connected to the aspiration probe.', 'description': 'Evaluated by collecting blood loss during the procedure (in 50 mL increments)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['interruption of pregnancy', 'Induced abortion', 'instrumental technique', 'women complications'], 'conditions': ['Induced Abortion', 'Instrumental Induced Abortion Between 14 and 16 Weeks of Amenorrhea']}, 'descriptionModule': {'briefSummary': "In France, induced abortions can be carried out by two different methods: the medicinal one, which involves taking medications to expel the pregnancy (MIFEPRISTONE and then MISOPROSTOL), and the instrumental one, which involves aspiration in the operating room.\n\nAccording to the high authority of health, before 9 weeks of amenorrhea, both methods are possible if there is no contraindication to one of them. After 9 weeks of amenorrhea, only the instrumental method is authorized.\n\nUntil March 2022, the maximal deadline to abort was 14 weeks of amenorrhea. On March 2nd 2022, a change in the law extended this time limit from 14 to 16 weeks of amenorrhea. Only one study was carried out following this change in France to assess the complication rate of late abortions (between 14 and 16 weeks of amenorrhea (AW)). This study was carried out at Trousseau Hospital in Paris, with a total of 46 patients. The results of this study were reassuring, with bleeding \\> 500 mL for only one patient (2.2%, 95% CI \\[0.0-6.4\\]) and no complications such as perforation, postoperative infection or revision surgery, or need for transfusion.\n\nHowever, this paper is the only French study which evaluated the operative risks of late abortion since the change in the law, and its power is small. There is a need to assess the operative risks of late abortion on a larger cohort.\n\nThat's why the investigators had the idea to conduct a study looking at all instrumental abortions performed in Croix Rousse Hospital in Lyon between March 2022 and March 2023, representing around 700 procedures. The aim of the study is to compare the complication rates of instrumental abortions between 14 and 16 weeks of amenorrhea versus those carried out before 14 weeks."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult women who undergone a surgical abortion at Croix Rousse Hospital in Lyon between March 2022 and March 2023.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Eligibility Criteria \\*\n\n* Inclusion Criteria \\* :\n\n * Surgical induced abortion\n * At Croix Rousse hospital, Lyon\n * Between March 2022 and March 2023\n* Exclusion Criteria \\* :\n\n * Minor patients'}, 'identificationModule': {'nctId': 'NCT06871618', 'acronym': 'TARDIVG', 'briefTitle': 'Retrospective Study of Surgical Induced Abortions Between 14 and 16 Weeks of Amenorrhea At Croix Rousse University Hospital in Lyon', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Retrospective Study of Surgical Induced Abortions Between 14 and 16 Weeks of Amenorrhea At Croix Rousse University Hospital in Lyon', 'orgStudyIdInfo': {'id': '24-5192'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women who undergone a surgical induced abortion before 14AW', 'description': 'Women who undergone a surgical induced abortion at Croix Rousse Hospital in Lyon between March 2022 and March 2023 before 14AW', 'interventionNames': ['Other: Retrospective']}, {'label': 'Women who undergone a surgical induced abortion between 14 and 16AW.', 'description': 'Women who undergone a surgical induced abortion at Croix Rousse Hospital in Lyon between March 2022 and March 2023 between 14 and 16AW.'}], 'interventions': [{'name': 'Retrospective', 'type': 'OTHER', 'description': 'Retrospective Operative risk in patients undergoing instrumental abortion', 'armGroupLabels': ['Women who undergone a surgical induced abortion before 14AW']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lyon', 'country': 'France', 'facility': 'Croix Rousse University Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}