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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 / Hysteroscopic device placement | Patients that had undergone sterilization through hysteroscopic device placement |
| |
| Cohort 2 / Tubal ligation | Patients that had undergone sterilization through tubal ligation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hysteroscopic device placement including Essure (ESS305, BAY1454032) | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | Retrospective analysis of 10 year period |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients having unintended pregnancy post-sterilization | Exclusion of any IVF pregnancy, and any pregnancy preceding sterilization | Retrospective analysis of 10 year period |
| Percentage of patients having unintended ectopic pregnancy post-sterilization |
Inclusion Criteria:
Exclusion Criteria:
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Women aged 18 - 49 at index date who underwent hysteroscopic device sterilization procedure or tubal ligation sterilization procedure.
Index date: Date of sterilization procedure
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Jersey | New Jersey | United States |
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| ID | Term |
|---|---|
| D013246 | Sterilization, Tubal |
| ID | Term |
|---|---|
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013245 | Sterilization, Reproductive |
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| Tubal ligation | Procedure | 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 |
|
Exclusion of any IVF pregnancy, and any pregnancy preceding sterilization |
| Retrospective analysis of 10 year period |
| Percentage of patients that have salpingectomy (unilateral, bilateral) subsequent to sterilization | Retrospective analysis of 10 year period |
| Average time in days from sterilization to salpingectomy and Kaplan-Meier-Estimator curve (number of occurrence over time) | 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) | Retrospective analysis of 10 year period |
| Percentage of patients with repeat sterilization surgery | 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) | Retrospective analysis of 10 year period |
| Percentage of patients who undergo a Modified Hysterosalpingogram (HSG) test | Retrospective analysis of 10 year period |
| Percentage of patients who did not have a Modified HSG and unintentionally got pregnant | Retrospective analysis of 10 year period |
| Percentage of patients having readmission within 30 days of sterilization | Retrospective analysis of 10 year period |
| Percentage of patients having removal of device inserts other than hysterectomy or salpingectomy | Retrospective analysis of 10 year period |
| Percentage of patients who had Modified HSG and got pregnant | Retrospective analysis of 10 year period |