Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2025-12-29 @ 6:36 PM
Study NCT ID:
NCT02532361
Status:
COMPLETED
Last Update Posted:
2016-12-23
First Post:
2015-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proportion of Hysterectomy After Female Sterilization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013246', 'term': 'Sterilization, Tubal'}], 'ancestors': [{'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013245', 'term': 'Sterilization, Reproductive'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10578}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-22', 'studyFirstSubmitDate': '2015-08-21', 'studyFirstSubmitQcDate': '2015-08-21', 'lastUpdatePostDateStruct': {'date': '2016-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of patients having unintended pregnancy post-sterilization', 'timeFrame': 'Retrospective analysis of 10 year period', 'description': 'Exclusion of any IVF pregnancy, and any pregnancy preceding sterilization'}, {'measure': 'Percentage of patients having unintended ectopic pregnancy post-sterilization', 'timeFrame': 'Retrospective analysis of 10 year period', 'description': 'Exclusion of any IVF pregnancy, and any pregnancy preceding sterilization'}, {'measure': 'Percentage of patients that have salpingectomy (unilateral, bilateral) subsequent to sterilization', 'timeFrame': 'Retrospective analysis of 10 year period'}, {'measure': 'Average time in days from sterilization to salpingectomy and Kaplan-Meier-Estimator curve (number of occurrence over time)', 'timeFrame': 'Retrospective analysis of 10 year period'}, {'measure': 'Average time in days from sterilization to removal of device inserts other than hysterectomy or salpingectomy and Kaplan-Meier-Estimator curve (number of occurrence over time)', 'timeFrame': 'Retrospective analysis of 10 year period'}, {'measure': 'Percentage of patients with repeat sterilization surgery', 'timeFrame': 'Retrospective analysis of 10 year period'}, {'measure': 'Average time in days from first sterilization to repeat sterilization surgery and Kaplan-Meier-Estimator curve (number of occurrence over time)', 'timeFrame': 'Retrospective analysis of 10 year period'}, {'measure': 'Percentage of patients who undergo a Modified Hysterosalpingogram (HSG) test', 'timeFrame': 'Retrospective analysis of 10 year period'}, {'measure': 'Percentage of patients who did not have a Modified HSG and unintentionally got pregnant', 'timeFrame': 'Retrospective analysis of 10 year period'}, {'measure': 'Percentage of patients having readmission within 30 days of sterilization', 'timeFrame': 'Retrospective analysis of 10 year period'}, {'measure': 'Percentage of patients having removal of device inserts other than hysterectomy or salpingectomy', 'timeFrame': 'Retrospective analysis of 10 year period'}, {'measure': 'Percentage of patients who had Modified HSG and got pregnant', 'timeFrame': 'Retrospective analysis of 10 year period'}], 'primaryOutcomes': [{'measure': 'Percentage of patients having hysterectomy procedure post-sterilization through hysteroscopic device placement', 'timeFrame': 'Retrospective analysis of 10 year period', 'description': 'The study will also describe sub-outcomes related to post-sterilization hysterectomy procedure including: i. Average time (in days) from index date (sterilization) to hysterectomy ii. Percentage of patients having hysterectomy (abdominal) iii. Percentage of patients having hysterectomy (vaginal) iv. Percentage of patients having hysterectomy (laproscopically assisted vaginal hysterectomy - LAVH) v. Percentage of patients having hysterectomy (abdominal, vaginal and LAVH)'}, {'measure': 'Percentage of patients having hysterectomy procedure post-sterilization through through tubal ligation', 'timeFrame': 'Retrospective analysis of 10 year period', 'description': 'The study will also describe sub-outcomes related to post-sterilization hysterectomy procedure including: i. Average time (in days) from index date (sterilization) to hysterectomy ii. Percentage of patients having hysterectomy (abdominal) iii. Percentage of patients having hysterectomy (vaginal) iv. Percentage of patients having hysterectomy (laproscopically assisted vaginal hysterectomy - LAVH) v. Percentage of patients having hysterectomy (abdominal, vaginal and LAVH)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sterilization', 'Hysteroscopic Device Placement', 'Tubal Ligation'], 'conditions': ['Hysterectomy']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to describe the proportion of hysterectomy in patients that had undergone sterilization through hysteroscopic device placement and the patients that had undergone sterilization through tubal ligation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women aged 18 - 49 at index date who underwent hysteroscopic device sterilization procedure or tubal ligation sterilization procedure.\n\nIndex date: Date of sterilization procedure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18 to 49 years at index date\n* Gender: Female\n* Diagnosis: Women who underwent hysteroscopic device sterilization procedure\n* Diagnosis: Women who underwent tubal ligation sterilization procedure (includes laparoscopic tubal ligation), and salpingectomy\n\nExclusion Criteria:\n\n* Patients undergoing in-vitro fertilization (IVF) procedures\n* Embryo transfer, intrauterine\n* Follicle puncture for oocyte retrieval, any method'}, 'identificationModule': {'nctId': 'NCT02532361', 'briefTitle': 'Proportion of Hysterectomy After Female Sterilization', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Retrospective Analysis to Describe the Proportion of Hysterectomy After Female Sterilization With Hysteroscopic Device or Tubal Ligation Using Intermountain Healthcare Database in the US', 'orgStudyIdInfo': {'id': '18473'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1 / Hysteroscopic device placement', 'description': 'Patients that had undergone sterilization through hysteroscopic device placement', 'interventionNames': ['Device: Hysteroscopic device placement including Essure (ESS305, BAY1454032)']}, {'label': 'Cohort 2 / Tubal ligation', 'description': 'Patients that had undergone sterilization through tubal ligation', 'interventionNames': ['Procedure: Tubal ligation']}], 'interventions': [{'name': 'Hysteroscopic device placement including Essure (ESS305, BAY1454032)', 'type': 'DEVICE', 'description': 'Essure is a permanent, minimally invasive, non-hormonal implantable device used for contraception and Adiana sterilization method is a combination of controlled thermal damage to the lining of the fallopian tube followed by insertion of a non-absorbable biocompatible silicone elastomer matrix within the tubal lumen', 'armGroupLabels': ['Cohort 1 / Hysteroscopic device placement']}, {'name': 'Tubal ligation', 'type': 'PROCEDURE', 'description': "Tubal ligation or tubectomy is a surgical procedure for sterilization in which a woman's fallopian tubes are clamped and blocked, or severed and sealed, either method of which prevents eggs from reaching the uterus for implantation", 'armGroupLabels': ['Cohort 2 / Tubal ligation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'New Jersey', 'state': 'New Jersey', 'country': 'United States'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}