Trial Condition(s):

Contraception

Retrospective Claims Analysis of Hysterectomy after sterilization

Bayer Identifier:

18477

ClinicalTrials.gov Identifier:

NCT02527278

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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?

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

Trial Summary

Enrollment Goal
19317
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Essure (ESS305, BAY1454032)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Whippany, United States

Status
Completed
 

Trial Design