Intrauterine Device (IUD) Self Removal

NCT05191238 | Terminated

• 1 other identifier: H-42042
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

IUD Removal

Keywords

Self removal of IUD; Educational video; Simulation; Patient education; Intrauterine device; Contraception

Outcome Measures

Primary Outcomes (2)

• 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

• Proportion of participants who attempt IUD self-removal

  Attempt Yes/No

  15-30 minutes

Secondary Outcomes (1)

• Success of IUD self removal

  1 day

Study Arms (1)

Participants consented for IUD removal

EXPERIMENTAL

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

Interventions

IUD self-removal education OTHER

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

Participants consented for IUD removal

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current incarceration

Sponsors & Collaborators

• Boston Medical Center: lead
• Society of Family Planning: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Study Officials

• Melissa Wong, MD

  Boston Medical Center, Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 13, 2022
• Study Start: February 22, 2022
• Primary Completion: December 12, 2022
• Study Completion: December 12, 2022
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)