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Proportion of Hysterectomy After Female Sterilization

Completed
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
Inclusion Criteria
  • 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
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Exclusion Criteria
  • Patients undergoing in-vitro fertilization (IVF) procedures
  • Embryo transfer, intrauterine
  • Follicle puncture for oocyte retrieval, any method
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Cohort 1 / Hysteroscopic device placementHysteroscopic device placement including Essure (ESS305, BAY1454032)Patients that had undergone sterilization through hysteroscopic device placement
Cohort 2 / Tubal ligationTubal ligationPatients that had undergone sterilization through tubal ligation
Primary Outcome Measures
NameTimeMethod
Percentage of patients having hysterectomy procedure post-sterilization through hysteroscopic device placementRetrospective 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 ligationRetrospective 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
NameTimeMethod
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