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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06042556
Other study ID # STUDY00014317
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 3, 2021
Est. completion date February 16, 2023

Study information

Verified date September 2023
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigators previously developed a guide to help people with IUD self-removal. In this randomized study, the goal is to see if this guide makes it easier for IUD-users to remove their own IUDs. The main question the study aims to answer is: -Does use of the previously developed IUD self-removal guide increase rates of self removal? Participants will: - Complete a pre-study survey - Be randomized to self-removal with use of the guide or no additional resource - Self-select participation at home or in clinic - Attempt IUD self-removal either at home or in clinic - Complete a post-study survey. Investigators will compare rates of successful self-removal between those randomized to the guide to those randomized to no additional resource to see if increases success.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date February 16, 2023
Est. primary completion date February 16, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 14 Years and older
Eligibility Inclusion Criteria: - Ages 14 and older - IUD in place and desiring removal - Interest in attempting self-removal - English speaking - Working cell-phone with camera. Exclusion Criteria: - Not meeting above inclusion criteria, no other specific exclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Other:
IUD self-removal guide
We previously developed an online guide for IUD self-removal through an iterative process including advice from key expert informants, focus groups, interviews, and a pilot clinical study. It includes an online animation, step-by-step guide, troubleshooting tips, and information about pregnancy and contraception.

Locations

Country Name City State
United States Cedar River Clinics Renton Washington

Sponsors (1)

Lead Sponsor Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of successful IUD self-removal rates Successful self-removal will be reported by participants on the post-study survey and documented with an uploaded photo of the removed IUD on a study ruler sheet. Rates of successful self-removal will be compared between those randomized to the guide versus no additional resource. The post study survey will be completed within 48 hours of study participation. Participants schedule their participation on average 1-3 months from study enrollment but up to 1 year (the duration of the study being open).
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