Clinical trial NCT02532361: Proportion of Hysterectomy After Female Sterilization
Official title: A Retrospective Analysis to Describe the Proportion of Hysterectomy After Female Sterilization With Hysteroscopic Device or Tubal Ligation Using Intermountain Healthcare Database in the US
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hysterectomy
Keywords: Sterilization
Hysteroscopic Device Placement
Tubal Ligation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-08-25
Enrollment: 10578
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 18 - 49 at index date who underwent hysteroscopic device sterilization procedure or tubal ligation sterilization procedure.

Index date: Date of sterilization procedure

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.


Eligibility criteria: 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

Exclusion Criteria:

* Patients undergoing in-vitro fertilization (IVF) procedures
* Embryo transfer, intrauterine
* Follicle puncture for oocyte retrieval, any method

Primary outcomes:
measure: Percentage of patients having hysterectomy procedure post-sterilization through hysteroscopic device placement
timeFrame: Retrospective analysis of 10 year period
measure: Percentage of patients having hysterectomy procedure post-sterilization through through tubal ligation
timeFrame: Retrospective analysis of 10 year period
Secondary outcomes:
Other outcomes:
measure: Percentage of patients having unintended pregnancy post-sterilization
timeFrame: Retrospective analysis of 10 year period
measure: Percentage of patients having unintended ectopic pregnancy post-sterilization
timeFrame: Retrospective analysis of 10 year period
measure: Percentage of patients that have salpingectomy (unilateral, bilateral) subsequent to sterilization
timeFrame: Retrospective analysis of 10 year period
measure: Average time in days from sterilization to salpingectomy and Kaplan-Meier-Estimator curve (number of occurrence over time)
timeFrame: Retrospective analysis of 10 year period
measure: 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)
timeFrame: Retrospective analysis of 10 year period
measure: Percentage of patients with repeat sterilization surgery
timeFrame: Retrospective analysis of 10 year period
measure: Average time in days from first sterilization to repeat sterilization surgery and Kaplan-Meier-Estimator curve (number of occurrence over time)
timeFrame: Retrospective analysis of 10 year period
measure: Percentage of patients who undergo a Modified Hysterosalpingogram (HSG) test
timeFrame: Retrospective analysis of 10 year period
measure: Percentage of patients who did not have a Modified HSG and unintentionally got pregnant
timeFrame: Retrospective analysis of 10 year period
measure: Percentage of patients having readmission within 30 days of sterilization
timeFrame: Retrospective analysis of 10 year period
measure: Percentage of patients having removal of device inserts other than hysterectomy or salpingectomy
timeFrame: Retrospective analysis of 10 year period
measure: Percentage of patients who had Modified HSG and got pregnant
timeFrame: Retrospective analysis of 10 year period
Locations:
city: New Jersey
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: