Proportion of Hysterectomy After Female Sterilization

Hysterectomy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02532361
• Other study ID #: 18473
• Status: Completed
• Phase: N/A
• First received: August 21, 2015
• Last updated: December 22, 2016
• Start date: August 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10578
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hysterectomy

Intervention

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

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of patients having unintended pregnancy post-sterilization	Exclusion of any IVF pregnancy, and any pregnancy preceding sterilization	Retrospective analysis of 10 year period	No
Other	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	No
Other	Percentage of patients that have salpingectomy (unilateral, bilateral) subsequent to sterilization		Retrospective analysis of 10 year period	No
Other	Average time in days from sterilization to salpingectomy and Kaplan-Meier-Estimator curve (number of occurrence over time)		Retrospective analysis of 10 year period	No
Other	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	No
Other	Percentage of patients with repeat sterilization surgery		Retrospective analysis of 10 year period	No
Other	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	No
Other	Percentage of patients who undergo a Modified Hysterosalpingogram (HSG) test		Retrospective analysis of 10 year period	No
Other	Percentage of patients who did not have a Modified HSG and unintentionally got pregnant		Retrospective analysis of 10 year period	No
Other	Percentage of patients having readmission within 30 days of sterilization		Retrospective analysis of 10 year period	No
Other	Percentage of patients having removal of device inserts other than hysterectomy or salpingectomy		Retrospective analysis of 10 year period	No
Other	Percentage of patients who had Modified HSG and got pregnant		Retrospective analysis of 10 year period	No
Primary	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	No
Primary	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	No

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