Retrospective Claims Analysis of Hysterectomy After Sterilization

Study Overview
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Brief Summary
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The research questions are: What is the proportion of women undergoing hysterectomy after hysteroscopic sterilization or laparoscopic tubal ligation? What is the proportion of women undergoing salpingectomy, salpingostomy, or hysteroscopy after hysteroscopic sterilization or laparoscopic tubal ligation? What is the proportion of women who have a diagnosis of pelvic pain after hysteroscopic sterilization or laparoscopic tubal ligation?

Official Title
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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

Conditions
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Contraception

Intervention / Treatment
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* Procedure: Laparoscopic tubal ligation
* Procedure: Hysteroscopic sterilization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Laparoscopic tubal ligation (no pain)<br>Women who have laparoscopic tubal ligation, with no previous diagnosis of pain at baseline | Procedure: Laparoscopic tubal ligation<br>* Female permanent birth control method performed via a surgical procedure<br>|
| Laparoscopic tubal ligation (pain)<br>Women who have laparoscopic tubal ligation, with a previous diagnosis of pain at baseline | Procedure: Laparoscopic tubal ligation<br>* Female permanent birth control method performed via a surgical procedure<br>|
| Hysteroscopic sterilization (no pain)<br>Women who have hysteroscopic sterilization, with no previous diagnosis of pain at baseline | Procedure: Hysteroscopic sterilization<br>* Female permanent birth control method performed via placement of a device<br>|
| Hysteroscopic sterilization (pain)<br>Women who have hysteroscopic sterilization, with a previous diagnosis of pain at baseline | Procedure: Hysteroscopic sterilization<br>* Female permanent birth control method performed via placement of a device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |