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Proportion of Hysterectomy After Female Sterilization

NCT ID: NCT02532361

Last Updated: 2016-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10578 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hysterectomy

Keywords

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Sterilization Hysteroscopic Device Placement Tubal Ligation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort 1 / Hysteroscopic device placement

Patients that had undergone sterilization through hysteroscopic device placement

Hysteroscopic device placement including Essure (ESS305, BAY1454032)

Intervention Type 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

Cohort 2 / Tubal ligation

Patients that had undergone sterilization through tubal ligation

Tubal ligation

Intervention Type PROCEDURE

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

Interventions

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Hysteroscopic device placement including Essure (ESS305, BAY1454032)

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

Intervention Type DEVICE

Tubal ligation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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New Jersey, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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18473

Identifier Type: -

Identifier Source: org_study_id