Retrospective Claims Analysis of Hysterectomy After Sterilization

Contraception Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02527278
• Other study ID #: 18477
• Status: Completed
• Phase: N/A
• First received: August 17, 2015
• Last updated: March 20, 2017
• Start date: July 30, 2015
• Est. completion date: February 9, 2016

Study information

• Verified date: March 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19317
• Est. completion date: February 9, 2016
• Est. primary completion date: February 9, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Procedure:
• Laparoscopic tubal ligation
Female permanent birth control method performed via a surgical procedure
• Hysteroscopic sterilization
Female permanent birth control method performed via placement of a device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of women undergoing hysterectomy after hysteroscopic sterilization or laparoscopic tubal ligation		Within 12 months after the procedure
Secondary	Proportion of women undergoing salpingectomy after hysteroscopic sterilization or laparoscopic tubal ligation		Within 12 months after the procedure
Secondary	Proportion of women undergoing salpingostomy after hysteroscopic sterilization or laparoscopic tubal ligation		Within 12 months after the procedure
Secondary	Proportion of women undergoing hysteroscopy after hysteroscopic sterilization or laparoscopic tubal ligation		Within 12 months after the procedure
Secondary	Proportion of women who have a diagnosis of pelvic pain after hysteroscopic sterilization or laparoscopic tubal ligation		Within 12 months after the procedure

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