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NCT05339555 Clinical Trial

IUD Self-Removal Study

IUD Clinical Trial

Official title:
IUD Self-Removal: A Study to Pilot the Feasibility of a Novel Technique

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05339555
Other study ID # STUDY00023967
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 10, 2022
Est. completion date December 31, 2024

Study information
Verified date July 2023
Source Oregon Health and Science University
Contact Women's Health Research Unit Department of Ob/Gyn
Phone 503-494-3666
Email whru@ohsu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 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.

Locations
Country Name City State
United States Oregon Health & Science Univeristy Portland Oregon

Sponsors (1)
Lead Sponsor Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effectiveness of IUD Self-Removal Techniques Proportion of participants who successfully remove their IUDs Immediately after IUD Removal
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