An observational study in Hysterectomy, sponsored by Bayer. Completed at 1 site in United States. Open to female participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2016-12-23.
Sponsored by Bayer · Observational
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.
Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women aged 18 - 49 at index date who underwent hysteroscopic device sterilization procedure or tubal ligation sterilization procedure.
Index date: Date of sterilization procedure
Exclusion Criteria:
Patients that had undergone sterilization through hysteroscopic device placement
Device: Hysteroscopic device placement including Essure (ESS305, BAY1454032)
Patients that had undergone sterilization through tubal ligation
Procedure: Tubal ligation
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
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
Percentage of patients having hysterectomy procedure post-sterilization through hysteroscopic device placement
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)
Time frame: Retrospective analysis of 10 year period
Percentage of patients having hysterectomy procedure post-sterilization through through tubal ligation
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)
Time frame: Retrospective analysis of 10 year period
Percentage of patients having unintended pregnancy post-sterilization
Exclusion of any IVF pregnancy, and any pregnancy preceding sterilization
Time frame: Retrospective analysis of 10 year period
Percentage of patients having unintended ectopic pregnancy post-sterilization
Exclusion of any IVF pregnancy, and any pregnancy preceding sterilization
Time frame: Retrospective analysis of 10 year period
Percentage of patients that have salpingectomy (unilateral, bilateral) subsequent to sterilization
Time frame: Retrospective analysis of 10 year period
Average time in days from sterilization to salpingectomy and Kaplan-Meier-Estimator curve (number of occurrence over time)
Time frame: Retrospective analysis of 10 year period
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)
Time frame: Retrospective analysis of 10 year period
Percentage of patients with repeat sterilization surgery
Time frame: Retrospective analysis of 10 year period
Average time in days from first sterilization to repeat sterilization surgery and Kaplan-Meier-Estimator curve (number of occurrence over time)
Time frame: Retrospective analysis of 10 year period
Percentage of patients who undergo a Modified Hysterosalpingogram (HSG) test
Time frame: Retrospective analysis of 10 year period
Percentage of patients who did not have a Modified HSG and unintentionally got pregnant
Time frame: Retrospective analysis of 10 year period
Percentage of patients having readmission within 30 days of sterilization
Time frame: Retrospective analysis of 10 year period
Percentage of patients having removal of device inserts other than hysterectomy or salpingectomy
Time frame: Retrospective analysis of 10 year period
Percentage of patients who had Modified HSG and got pregnant
Time frame: Retrospective analysis of 10 year period
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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