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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05191238
Other study ID # H-42042
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT00243815 - Use of Ibuprofen to Prevent IUD Site Effects Phase 3
Completed NCT01730911 - Quick Start Insertion of Mirena and ParaGard N/A