Retrospective Claims Analysis of Hysterectomy After Sterilization

Bayer

Status: Completed

Conditions: Contraception

Treatments: Procedure: Hysteroscopic sterilization; Procedure: Laparoscopic tubal ligation

Study type: Observational

Funder types: Industry

Identifiers

NCT02527278

18477

Details and patient eligibility

About

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?

Enrollment: 19,317 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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 design

19,317 participants in 4 patient groups

Laparoscopic tubal ligation (no pain)

Description:

Women who have laparoscopic tubal ligation, with no previous diagnosis of pain at baseline

Treatment:

Procedure: Laparoscopic tubal ligation

Laparoscopic tubal ligation (pain)

Description:

Women who have laparoscopic tubal ligation, with a previous diagnosis of pain at baseline

Treatment:

Procedure: Laparoscopic tubal ligation

Hysteroscopic sterilization (no pain)

Description:

Women who have hysteroscopic sterilization, with no previous diagnosis of pain at baseline

Treatment:

Procedure: Hysteroscopic sterilization

Hysteroscopic sterilization (pain)

Description:

Women who have hysteroscopic sterilization, with a previous diagnosis of pain at baseline

Treatment:

Procedure: Hysteroscopic sterilization