Retrospective Claims Analysis of Hysterectomy After Sterilization
NCT ID: NCT02527278
Last Updated: 2017-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
19317 participants
OBSERVATIONAL
2015-07-30
2016-02-09
Brief Summary
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1. What is the proportion of women undergoing hysterectomy after hysteroscopic sterilization or laparoscopic tubal ligation?
2. What is the proportion of women undergoing salpingectomy, salpingostomy, or hysteroscopy after hysteroscopic sterilization or laparoscopic tubal ligation?
3. What is the proportion of women who have a diagnosis of pelvic pain after hysteroscopic sterilization or laparoscopic tubal ligation?
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Laparoscopic tubal ligation (no pain)
Women who have laparoscopic tubal ligation, with no previous diagnosis of pain at baseline
Laparoscopic tubal ligation
Female permanent birth control method performed via a surgical procedure
Laparoscopic tubal ligation (pain)
Women who have laparoscopic tubal ligation, with a previous diagnosis of pain at baseline
Laparoscopic tubal ligation
Female permanent birth control method performed via a surgical procedure
Hysteroscopic sterilization (no pain)
Women who have hysteroscopic sterilization, with no previous diagnosis of pain at baseline
Hysteroscopic sterilization
Female permanent birth control method performed via placement of a device
Hysteroscopic sterilization (pain)
Women who have hysteroscopic sterilization, with a previous diagnosis of pain at baseline
Hysteroscopic sterilization
Female permanent birth control method performed via placement of a device
Interventions
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Laparoscopic tubal ligation
Female permanent birth control method performed via a surgical procedure
Hysteroscopic sterilization
Female permanent birth control method performed via placement of a device
Eligibility Criteria
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Inclusion Criteria
* at least one claim of the hysteroscopic sterilization procedure or interval laparoscopic tubal ligation at any time during January 1, 2010 -December 31, 2012
* Had 6 months of continuous medical and pharmacy benefits pre-index date which is considered the baseline period to capture all patient characteristics prior to the procedure
* Had 12 months of continuous medical and pharmacy benefits post-index date (i.e., follow-up period)
Exclusion Criteria
* Women who had claims of a sterilization procedure during the baseline period
* Women who had a claim for pregnancy or delivery within 6 weeks prior to the index date
* Women who had more than one type of sterilization procedure (i.e., combination of hysteroscopic sterilization, laparoscopic tubal ligation or mini-laparotomy) on the same index date
* Women who had concurrent procedures on the same day as the index sterilization procedure that were performed for reasons beyond the purpose of sterilization
18 Years
49 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Whippany, New Jersey, United States
Countries
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Other Identifiers
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18477
Identifier Type: -
Identifier Source: org_study_id
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