Proportion of Hysterectomy After Female Sterilization

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

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.

Study Overview

• Status: Completed
• Conditions: Hysterectomy
• Intervention / Treatment: Device: Hysteroscopic device placement including Essure (ESS305, BAY1454032); Procedure: Tubal ligation

• Study Type: Observational
• Enrollment (Actual): 10578

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Jersey, New Jersey, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1 / Hysteroscopic device placement; Patients that had undergone sterilization through hysteroscopic device placement	Device: Hysteroscopic device placement including Essure (ESS305, BAY1454032); 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
Cohort 2 / Tubal ligation; Patients that had undergone sterilization through tubal ligation	Procedure: Tubal ligation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: August 21, 2015
• First Submitted That Met QC Criteria: August 21, 2015
• First Posted (Estimate): August 25, 2015

Study Record Updates

• Last Update Posted (Estimate): December 23, 2016
• Last Update Submitted That Met QC Criteria: December 22, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Tubal Ligation; Sterilization; Hysteroscopic Device Placement
• Other Study ID Numbers: 18473