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Intrauterine Device (IUD) Self Removal

NCT ID: NCT05191238

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-22

Study Completion Date

2022-12-12

Brief Summary

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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.

Detailed Description

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Conditions

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IUD Removal

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

IUD self-removal education

Intervention Type OTHER

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

Interventions

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IUD self-removal education

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Society of Family Planning

OTHER

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Melissa Wong, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center, Obstetrics and Gynecology

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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H-42042

Identifier Type: -

Identifier Source: org_study_id