IUD Self-Removal Study

NCT ID: NCT05339555

Last Updated: 2025-05-31

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

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-10

Study Completion Date

2025-12-31

Brief Summary

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This is a pilot study designed to test the effectiveness of several techniques for intrauterine device (IUD) self-removal and to understand patient preferences regarding IUD self-removal and indicators of success as well as understanding the impacts of IUD self-removal on other clinical care.

Detailed Description

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The Investigators propose to test a novel method for self-removal of IUDs in an effort to increase the proportion of patients who are able to successfully and safely remove their IUD when desired. Participants will attempt self-removal in office, where a provider will be able to remove the IUD if unsuccessful. Participants will be instructed on current and novel techniques and the investigators will examine indicators of success as well as patient and provider preferences.

Conditions

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IUD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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IUD Self-Removal

Group Type OTHER

Instructions for IUD Self-Removal Provided to Participant

Intervention Type OTHER

The provider will offer any individual presenting for in-person IUD removal or exchange (removal-replacement) the option for self-removal. The participant will be provided a 'how to' instruction sheet with information on positioning and what to expect. The participant will first attempt removal with clean hands if desired, then utilizing non-sterile, clean gloves (not explicitly tested in prior studies) and if that fails, the use of a menstrual cup (a novel technique). If not successful, the provider will perform standard IUD removal in the clinic.

Interventions

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Instructions for IUD Self-Removal Provided to Participant

The provider will offer any individual presenting for in-person IUD removal or exchange (removal-replacement) the option for self-removal. The participant will be provided a 'how to' instruction sheet with information on positioning and what to expect. The participant will first attempt removal with clean hands if desired, then utilizing non-sterile, clean gloves (not explicitly tested in prior studies) and if that fails, the use of a menstrual cup (a novel technique). If not successful, the provider will perform standard IUD removal in the clinic.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Presenting at clinic for IUD removal or exchange
* Willing and able to give consent with literacy in English or Spanish

Exclusion Criteria

* Participants who are referred for a complicated IUD removal such as a stingless IUD, prior failed IUD removal attempt, or an IUD failure.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Jessica Reid

Clinical Instructor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jessica Reid, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health & Science Univeristy

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Women's Health Research Unit Department of Ob/Gyn

Role: CONTACT

503-494-3666

Facility Contacts

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Jessica Reid, MD

Role: primary

Other Identifiers

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STUDY00023967

Identifier Type: -

Identifier Source: org_study_id

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