Intrauterine Device (IUD) Self Removal

IUD Removal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05191238
• Other study ID #: H-42042
• Status: Terminated
• Phase: N/A
• Start date: February 22, 2022
• Est. completion date: December 12, 2022

Study information

• Verified date: December 2023
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: December 12, 2022
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• IUD Removal

Intervention

Other:
• IUD self-removal education
Two part educational intervention (watching IUD self-removal video and practicing IUD removal on two simulation models)

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in proportion of participants who are willing to attempt IUD self-removal	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
Primary	Proportion of participants who attempt IUD self-removal	Attempt Yes/No	15-30 minutes
Secondary	Success of IUD self removal	Success Yes/No	1 day