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Trial record 1 of 1 for:    NCT02532361
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Proportion of Hysterectomy After Female Sterilization

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ClinicalTrials.gov Identifier: NCT02532361
Recruitment Status : Completed
First Posted : August 25, 2015
Last Update Posted : December 23, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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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.

Condition or disease Intervention/treatment
Hysterectomy Device: Hysteroscopic device placement including Essure (ESS305, BAY1454032) Procedure: Tubal ligation

Study Design
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Study Type : Observational
Actual Enrollment : 10578 participants
Observational Model: Cohort
Time Perspective: Retrospective
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 Start Date : August 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients having hysterectomy procedure post-sterilization through hysteroscopic device placement [ Time Frame: 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)

  2. Percentage of patients having hysterectomy procedure post-sterilization through through tubal ligation [ Time Frame: 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)


Other Outcome Measures:
  1. Percentage of patients having unintended pregnancy post-sterilization [ Time Frame: Retrospective analysis of 10 year period ]
    Exclusion of any IVF pregnancy, and any pregnancy preceding sterilization

  2. Percentage of patients having unintended ectopic pregnancy post-sterilization [ Time Frame: Retrospective analysis of 10 year period ]
    Exclusion of any IVF pregnancy, and any pregnancy preceding sterilization

  3. Percentage of patients that have salpingectomy (unilateral, bilateral) subsequent to sterilization [ Time Frame: Retrospective analysis of 10 year period ]
  4. Average time in days from sterilization to salpingectomy and Kaplan-Meier-Estimator curve (number of occurrence over time) [ Time Frame: Retrospective analysis of 10 year period ]
  5. 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) [ Time Frame: Retrospective analysis of 10 year period ]
  6. Percentage of patients with repeat sterilization surgery [ Time Frame: Retrospective analysis of 10 year period ]
  7. Average time in days from first sterilization to repeat sterilization surgery and Kaplan-Meier-Estimator curve (number of occurrence over time) [ Time Frame: Retrospective analysis of 10 year period ]
  8. Percentage of patients who undergo a Modified Hysterosalpingogram (HSG) test [ Time Frame: Retrospective analysis of 10 year period ]
  9. Percentage of patients who did not have a Modified HSG and unintentionally got pregnant [ Time Frame: Retrospective analysis of 10 year period ]
  10. Percentage of patients having readmission within 30 days of sterilization [ Time Frame: Retrospective analysis of 10 year period ]
  11. Percentage of patients having removal of device inserts other than hysterectomy or salpingectomy [ Time Frame: Retrospective analysis of 10 year period ]
  12. Percentage of patients who had Modified HSG and got pregnant [ Time Frame: Retrospective analysis of 10 year period ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02532361


Locations
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United States, New Jersey
New Jersey, New Jersey, United States
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02532361    
Other Study ID Numbers: 18473
First Posted: August 25, 2015    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2016
Keywords provided by Bayer:
Sterilization
Hysteroscopic Device Placement
Tubal Ligation