Retrospective Claims Analysis of Hysterectomy After Sterilization

NCT02527278 | Completed

• 1 other identifier: 18477
• Study Type: observational
• Target: 19,317
• Locations: 1 country
• Sites: 1

Brief Summary

The research questions are:

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

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

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

  Within 12 months after the procedure

Secondary Outcomes (4)

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

  Within 12 months after the procedure

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

  Within 12 months after the procedure

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

  Within 12 months after the procedure

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

  Within 12 months after the procedure

Study Arms (4)

Laparoscopic tubal ligation (no pain)

Women who have laparoscopic tubal ligation, with no previous diagnosis of pain at baseline

Procedure: Laparoscopic tubal ligation

Laparoscopic tubal ligation (pain)

Women who have laparoscopic tubal ligation, with a previous diagnosis of pain at baseline

Procedure: Laparoscopic tubal ligation

Hysteroscopic sterilization (no pain)

Women who have hysteroscopic sterilization, with no previous diagnosis of pain at baseline

Procedure: Hysteroscopic sterilization

Hysteroscopic sterilization (pain)

Women who have hysteroscopic sterilization, with a previous diagnosis of pain at baseline

Procedure: Hysteroscopic sterilization

Interventions

Laparoscopic tubal ligation PROCEDURE

Female permanent birth control method performed via a surgical procedure

Laparoscopic tubal ligation (no pain); Laparoscopic tubal ligation (pain)

Hysteroscopic sterilization PROCEDURE

Female permanent birth control method performed via placement of a device

Hysteroscopic sterilization (no pain); Hysteroscopic sterilization (pain)

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 18 - 49 at the time of the sterilization procedure from an administrative claims database

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Whippany, New Jersey, United States

Location

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: August 18, 2015
• Study Start: July 30, 2015
• Primary Completion: February 9, 2016
• Study Completion: February 9, 2016
• Last Updated: March 21, 2017

Record last verified: 2017-03

Locations

US (1)