Proportion of Hysterectomy After Female Sterilization
- Conditions
- Hysterectomy
- Interventions
- Device: Hysteroscopic device placement including Essure (ESS305, BAY1454032)Procedure: Tubal ligation
- Registration Number
- NCT02532361
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 10578
- Age: 18 to 49 years at index date
- Gender: Female
- Diagnosis: Women who underwent hysteroscopic device sterilization procedure
- Diagnosis: Women who underwent tubal ligation sterilization procedure (includes laparoscopic tubal ligation), and salpingectomy
- Patients undergoing in-vitro fertilization (IVF) procedures
- Embryo transfer, intrauterine
- Follicle puncture for oocyte retrieval, any method
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1 / Hysteroscopic device placement Hysteroscopic device placement including Essure (ESS305, BAY1454032) Patients that had undergone sterilization through hysteroscopic device placement Cohort 2 / Tubal ligation Tubal ligation Patients that had undergone sterilization through tubal ligation
- Primary Outcome Measures
Name Time Method Percentage of patients having hysterectomy procedure post-sterilization through hysteroscopic device placement Retrospective analysis of 10 year period 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)
Percentage of patients having hysterectomy procedure post-sterilization through through tubal ligation Retrospective analysis of 10 year period 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)
- Secondary Outcome Measures
Name Time Method