Intrauterine Device (IUD) Self Removal

December 18, 2023 updated by: Boston Medical Center

Patients Pull the Strings: A Pilot Study of IUD Self-Removal Simulation

This pilot research study will teach patients how to self-remove intrauterine contraceptive device (IUD) through an educational video and simulation and evaluate patient perspectives and experiences related to IUD self-removal with two surveys. Patients will be recruited for this study at the time of presentation to the office for IUD removal. After consenting to the procedure, participants will complete a pre-intervention survey, watch a video explaining how to self-remove the IUD, and use two models to simulate IUD removal. After completion of using the models to practice IUD removal, participants will complete a second short survey. The participant will then be given the option of attempting self-removal and be given time to attempt the removal. If the participant elects to have the provider remove their IUD, the provider will do so. At the end of the encounter, participants will fill out a final survey. Research staff will measure the length of the strings of all IUDs prior to routine disposal of the device.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • English or Spanish speaking
  • Present to Boston Medical Center Yawkey for removal of IUD and have been consented for removal
  • Are eligible for removal of IUD in the office setting

Exclusion Criteria:

  • Current incarceration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants consented for IUD removal
Participants will be shown an educational video about IUD self-removal and simulation models. After the video, participants will be given the choice to either attempt IUD self-removal or to have their provider perform standard removal. If a participant elects to attempt self-removal and fails, their provider will offer standard removal.
Other: IUD self-removal education
Two part educational intervention (watching IUD self-removal video and practicing IUD removal on two simulation models)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in proportion of participants who are willing to attempt IUD self-removal
Time Frame: baseline, 15-30 minutes
Participants will be asked before and after reviewing the educational video and practicing self-removal through simulation, if they are willing to attempt IUD self-removal. The change in the proportion willing to attempt IUD self-removal will be calculated.
baseline, 15-30 minutes
Proportion of participants who attempt IUD self-removal
Time Frame: 15-30 minutes
Attempt Yes/No
15-30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success of IUD self removal
Time Frame: 1 day
Success Yes/No
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Collaborators

Society of Family Planning

Investigators

  • Principal Investigator: Melissa Wong, MD, Boston Medical Center, Obstetrics and Gynecology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2022

Primary Completion (Actual)

December 12, 2022

Study Completion (Actual)

December 12, 2022

Study Registration Dates

First Submitted

December 29, 2021

First Submitted That Met QC Criteria

December 29, 2021

First Posted (Actual)

January 13, 2022

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-42042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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