Study Completed

Contraception

Bayer Identifier:

18477

ClinicalTrials.gov Identifier:

NCT02527278

EudraCT Number:

Not Available

EU CT Number:

Not Available

Retrospective Claims Analysis of Hysterectomy after sterilization

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?

Key Participants Requirements

Sex

Female

Age

18 - 49 Years

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

July 2015 - February 2016

Phase

N/A

Could I Receive a placebo

Products

Essure (ESS305, BAY1454032)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Whippany, United States

Primary Outcome

Proportion of women undergoing hysterectomy after hysteroscopic sterilization or laparoscopic tubal ligation
Time Frame:
Within 12 months after the procedure
Safety Issue:
No

Secondary Outcome

Proportion of women undergoing salpingectomy after hysteroscopic sterilization or laparoscopic tubal ligation
Time Frame:
Within 12 months after the procedure
Safety Issue:
No
Proportion of women undergoing salpingostomy after hysteroscopic sterilization or laparoscopic tubal ligation
Time Frame:
Within 12 months after the procedure
Safety Issue:
No
Proportion of women undergoing hysteroscopy after hysteroscopic sterilization or laparoscopic tubal ligation
Time Frame:
Within 12 months after the procedure
Safety Issue:
No
Proportion of women who have a diagnosis of pelvic pain after hysteroscopic sterilization or laparoscopic tubal ligation
Time Frame:
Within 12 months after the procedure
Safety Issue:
Yes

Trial design

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

Trial Type

Observational

Intervention Type

Procedure/Surgery

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer products.