Retrospective Claims Analysis of Hysterectomy After Sterilization

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

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?

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Procedure: Laparoscopic tubal ligation; Procedure: Hysteroscopic sterilization

• Study Type: Observational
• Enrollment (Actual): 19317

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Whippany, New Jersey, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Laparoscopic tubal ligation (no pain); Women who have laparoscopic tubal ligation, with no previous diagnosis of pain at baseline	Procedure: Laparoscopic tubal ligation; Female permanent birth control method performed via a surgical procedure
Laparoscopic tubal ligation (pain); Women who have laparoscopic tubal ligation, with a previous diagnosis of pain at baseline	Procedure: Laparoscopic tubal ligation; Female permanent birth control method performed via a surgical procedure
Hysteroscopic sterilization (no pain); Women who have hysteroscopic sterilization, with no previous diagnosis of pain at baseline	Procedure: Hysteroscopic sterilization; Female permanent birth control method performed via placement of a device
Hysteroscopic sterilization (pain); Women who have hysteroscopic sterilization, with a previous diagnosis of pain at baseline	Procedure: Hysteroscopic sterilization; Female permanent birth control method performed via placement of a device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of women undergoing hysterectomy after hysteroscopic sterilization or laparoscopic tubal ligation	Within 12 months after the procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2015
• Primary Completion (Actual): February 9, 2016
• Study Completion (Actual): February 9, 2016

Study Registration Dates

• First Submitted: August 17, 2015
• First Submitted That Met QC Criteria: August 17, 2015
• First Posted (Estimate): August 18, 2015

Study Record Updates

• Last Update Posted (Actual): March 21, 2017
• Last Update Submitted That Met QC Criteria: March 20, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 18477