NCT02532361

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,578

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 23, 2016

Status Verified

December 1, 2016

Enrollment Period

4 months

First QC Date

August 21, 2015

Last Update Submit

December 22, 2016

Conditions

Hysterectomy

Keywords

SterilizationHysteroscopic Device PlacementTubal Ligation

Outcome Measures

Primary Outcomes (2)

  • 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)

    Retrospective analysis of 10 year period

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

    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)

    Retrospective analysis of 10 year period

Other Outcomes (12)

  • Percentage of patients having unintended pregnancy post-sterilization

    Retrospective analysis of 10 year period

  • Percentage of patients having unintended ectopic pregnancy post-sterilization

    Retrospective analysis of 10 year period

  • Percentage of patients that have salpingectomy (unilateral, bilateral) subsequent to sterilization

    Retrospective analysis of 10 year period

  • +9 more other outcomes

Study Arms (2)

Cohort 1 / Hysteroscopic device placement

Patients that had undergone sterilization through hysteroscopic device placement

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

Cohort 2 / Tubal ligation

Patients that had undergone sterilization through tubal ligation

Procedure: Tubal ligation

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

Cohort 1 / Hysteroscopic device placement
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

Cohort 2 / Tubal ligation

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women aged 18 - 49 at index date who underwent hysteroscopic device sterilization procedure or tubal ligation sterilization procedure. Index date: Date of sterilization procedure

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

New Jersey, New Jersey, United States

Location

MeSH Terms

Interventions

Sterilization, Tubal

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, OperativeSterilization, Reproductive

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2015

First Posted

August 25, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 23, 2016

Record last verified: 2016-12

Locations

US(1)