Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-30 @ 8:05 PM
Study NCT ID:
NCT01776957
Status:
TERMINATED
Last Update Posted:
2018-05-04
First Post:
2013-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Abortion IUD & Recurrent Abortion 2005-2006
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007434', 'term': 'Intrauterine Devices'}], 'ancestors': [{'id': 'D003274', 'term': 'Contraceptive Devices, Female'}, {'id': 'D003273', 'term': 'Contraceptive Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1308}}, 'statusModule': {'whyStopped': 'This study is a retrospective chart review study, not a clinical trial.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-01', 'studyFirstSubmitDate': '2013-01-21', 'studyFirstSubmitQcDate': '2013-01-23', 'lastUpdatePostDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of repeat abortions at five years from the index abortions', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Correlation of repeat and index abortions with obstetrical, demographic and contraceptive history factors.', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Abortion rate', 'Intrauterine device'], 'conditions': ['Induced Abortion']}, 'descriptionModule': {'briefSummary': 'The rate of repeat abortions will be lowest in those women who choose immediate insertion of an IUD post-abortion versus those who immediately choose oral contraceptive pills and those who indicate all other contraceptive choices including no contraception The provision by the health system of IUDs for immediate insertion will result in the lowest health system costs.', 'detailedDescription': "The investigators intend to demonstrate whether there are statistically significant differences in the rates of repeat abortions between three groups: 1. women choosing to have an intrauterine device (IUD) inserted immediately post-abortion, 2. those choosing to begin oral contraceptives immediately post-abortion, and 3. all other choices for post abortion contraception including those stating an intention to obtain contraceptives at a later time or from an alternate location or to use no contraception. This data will then be used to conduct a cost-effectiveness analysis of health system provision for cost-free IUDs post-abortion. Thus, if providing a free IUD immediately post-abortion significantly reduces the rate of repeat abortions, it may be more cost- effective for health system services to provide free IUDs at abortion clinics than to field the costs associated with a higher rate of repeat abortions.\n\nThe researchers will conduct a retrospective observational cohort study by chart review. The researchers propose to review the charts of women undergoing abortions between January 1, 2005 and December 31, 2006 at Kelowna General Hospital's Women's Services Clinic. The researchers will record the following data from each chart: age, parity, gestational age, date of index therapeutic abortion (TA), dates of subsequent TAs, contraception used at the time of the index conception, contraceptive method chosen post-abortion, and outcome of follow-up at two weeks, such as expulsion of IUD. The researchers will also record the recurrent pregnancy rates."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female resident of Interior Health region seeking an abortion', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female resident of Interior Health region seeking an abortion between January 1, 2005 and December 31, 2006\n\nExclusion Criteria:\n\n* Women undergoing abortions for fetal genetic abnormalities'}, 'identificationModule': {'nctId': 'NCT01776957', 'briefTitle': 'Post Abortion IUD & Recurrent Abortion 2005-2006', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Preventing Repeat Abortion: Is the Immediate Insertion of Intrauterine Devices Post-abortion a Cost-effective Option Associated With Fewer Repeat Abortions? Findings From 2005-2006 Data', 'orgStudyIdInfo': {'id': 'H12-00829'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IUD', 'description': 'Repeat abortion rate in women receiving IUDs immediately post-abortion', 'interventionNames': ['Device: Device: Intrauterine device (IUD)']}], 'interventions': [{'name': 'Device: Intrauterine device (IUD)', 'type': 'DEVICE', 'description': 'Women choosing to have an intrauterine device (IUD) inserted immediately post-abortion', 'armGroupLabels': ['IUD']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Wendy Norman, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Wendy Norman', 'investigatorAffiliation': 'University of British Columbia'}}}}