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OpenTrials
Completed

NCT Number: NCT02527278

Retrospective Claims Analysis of Hysterectomy After Sterilization

The research questions are:

1. What is the proportion of women undergoing hysterectomy after hysteroscopic sterilization or laparoscopic tubal ligation? 2. What is the proportion of women undergoing salpingectomy, salpingostomy, or hysteroscopy after hysteroscopic sterilization or laparoscopic tubal ligation? 3. What is the proportion of women who have a diagnosis of pelvic pain after hysteroscopic sterilization or laparoscopic tubal ligation?

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Key information

Conditions

Age range

18 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

Whippany, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women aged 18 through 49 years at the index date
  • at least one claim of the hysteroscopic sterilization procedure or interval laparoscopic tubal ligation at any time during January 1, 2010 -December 31, 2012
  • Had 6 months of continuous medical and pharmacy benefits pre-index date which is considered the baseline period to capture all patient characteristics prior to the procedure
  • Had 12 months of continuous medical and pharmacy benefits post-index date (i.e., follow-up period)

Exclusion criteria

  • Women who underwent a postpartum tubal ligation procedure during the entire study period
  • Women who had claims of a sterilization procedure during the baseline period
  • Women who had a claim for pregnancy or delivery within 6 weeks prior to the index date
  • Women who had more than one type of sterilization procedure (i.e., combination of hysteroscopic sterilization, laparoscopic tubal ligation or mini-laparotomy) on the same index date
  • Women who had concurrent procedures on the same day as the index sterilization procedure that were performed for reasons beyond the purpose of sterilization

Treatment and study plan

Laparoscopic tubal ligation

Procedure

Female permanent birth control method performed via a surgical procedure

Hysteroscopic sterilization

Procedure

Female permanent birth control method performed via placement of a device

Primary outcomes

  1. Proportion of women undergoing hysterectomy after hysteroscopic sterilization or laparoscopic tubal ligation

    Time frame: Within 12 months after the procedure

Secondary outcomes

  1. Proportion of women undergoing salpingectomy after hysteroscopic sterilization or laparoscopic tubal ligation

    Time frame: Within 12 months after the procedure

  2. Proportion of women undergoing salpingostomy after hysteroscopic sterilization or laparoscopic tubal ligation

    Time frame: Within 12 months after the procedure

  3. Proportion of women undergoing hysteroscopy after hysteroscopic sterilization or laparoscopic tubal ligation

    Time frame: Within 12 months after the procedure

  4. Proportion of women who have a diagnosis of pelvic pain after hysteroscopic sterilization or laparoscopic tubal ligation

    Time frame: Within 12 months after the procedure

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Retrospective Claims Analysis to Calculate the Proportion of Women Undergoing Hysterectomy, Salpingectomy, Salpingostomy, Hysteroscopy or Who Had a Diagnosis of Pelvic Pain After Hysteroscopic Sterilization or Laparoscopic Tubal Ligation

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 18, 2015
Registry last updated
Mar 21, 2017

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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