Proportion of Hysterectomy After Female Sterilization

Bayer

Status: Completed

Conditions: Hysterectomy

Treatments: Procedure: Tubal ligation; Device: Hysteroscopic device placement including Essure (ESS305, BAY1454032)

Study type: Observational

Funder types: Industry

Identifiers

NCT02532361

18473

Details and patient eligibility

About

The objective of this study is to describe the proportion of hysterectomy in patients that had undergone sterilization through hysteroscopic device placement and the patients that had undergone sterilization through tubal ligation.

Enrollment: 10,578 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 18 to 49 years at index date
• Gender: Female
• Diagnosis: Women who underwent hysteroscopic device sterilization procedure
• Diagnosis: Women who underwent tubal ligation sterilization procedure (includes laparoscopic tubal ligation), and salpingectomy

Exclusion criteria

• Patients undergoing in-vitro fertilization (IVF) procedures
• Embryo transfer, intrauterine
• Follicle puncture for oocyte retrieval, any method

Trial design

10,578 participants in 2 patient groups

Cohort 1 / Hysteroscopic device placement

Description:

Patients that had undergone sterilization through hysteroscopic device placement

Treatment:

Device: Hysteroscopic device placement including Essure (ESS305, BAY1454032)

Cohort 2 / Tubal ligation

Description:

Patients that had undergone sterilization through tubal ligation

Treatment:

Procedure: Tubal ligation