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Completed

NCT Number: NCT02532361

Proportion of Hysterectomy After Female Sterilization

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.

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Key information

Conditions

Hysterectomy

Age range

18 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hysteroscopic device placement including Essure (ESS305, BAY1454032)

Device

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

Tubal ligation

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 25, 2015
Registry last updated
Dec 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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