Proportion of Hysterectomy After Female Sterilization

Bayer10,578 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

10,578

Conditions

Hysterectomy

Interventions

Hysteroscopic device placement including Essure (ESS305, BAY1454032)DEVICE

Essure is a permanent, minimally invasive, non-hormonal implantable device used for contraception and Adiana sterilization method is a combination of controlled thermal damage to the lining of the fallopian tube followed by insertion of a non-absorbable biocompatible silicone elastomer matrix within the tubal lumen

Tubal ligationPROCEDURE

Tubal ligation or tubectomy is a surgical procedure for sterilization in which a woman's fallopian tubes are clamped and blocked, or severed and sealed, either method of which prevents eggs from reaching the uterus for implantation

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 49 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

New Jersey, New Jersey, United States

Outcomes

Primary Outcomes

Percentage of patients having hysterectomy procedure post-sterilization through hysteroscopic device placement

The study will also describe sub-outcomes related to post-sterilization hysterectomy procedure including: i. Average time (in days) from index date (sterilization) to hysterectomy ii. Percentage of patients having hysterectomy (abdominal) iii. Percentage of patients having hysterectomy (vaginal) iv. Percentage of patients having hysterectomy (laproscopically assisted vaginal hysterectomy - LAVH) v. Percentage of patients having hysterectomy (abdominal, vaginal and LAVH)

Time frame: Retrospective analysis of 10 year period

Percentage of patients having hysterectomy procedure post-sterilization through through tubal ligation

Time frame: Retrospective analysis of 10 year period

Data from ClinicalTrials.gov

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