Retrospective Claims Analysis of Hysterectomy After Sterilization

Completed

• Conditions: Contraception
• Interventions: Procedure: Laparoscopic tubal ligation; Procedure: Hysteroscopic sterilization

• Registration Number: NCT02527278
• Lead Sponsor: Bayer

Brief Summary

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-30
• Study First Submitted: 2015-08-17
• Study First Submitted QC: 2015-08-17
• Study First Posted: 2015-08-18
• Primary Completion: 2016-02-09
• Study Completion: 2016-02-09
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-20
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19317

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Laparoscopic tubal ligation (pain)	Laparoscopic tubal ligation	Women who have laparoscopic tubal ligation, with a previous diagnosis of pain at baseline
Hysteroscopic sterilization (pain)	Hysteroscopic sterilization	Women who have hysteroscopic sterilization, with a previous diagnosis of pain at baseline
Laparoscopic tubal ligation (no pain)	Laparoscopic tubal ligation	Women who have laparoscopic tubal ligation, with no previous diagnosis of pain at baseline
Hysteroscopic sterilization (no pain)	Hysteroscopic sterilization	Women who have hysteroscopic sterilization, with no previous diagnosis of pain at baseline

Primary Outcome Measures

Name	Time	Method
Proportion of women undergoing hysterectomy after hysteroscopic sterilization or laparoscopic tubal ligation	Within 12 months after the procedure

Secondary Outcome Measures

Name	Time	Method
Proportion of women undergoing salpingectomy 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 undergoing salpingostomy 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