IUD Self-Removal: Evaluating an Online Guide for Self-removal in Clinical and Non-clinical Settings

Contraception Clinical Trial

Official title:

A Randomized Trial Evaluating the Effectiveness of a Previously Developed Online IUD Self-removal Guide Versus Basic Information Sheet in Clinical and Non-clinical Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06042556
• Other study ID #: STUDY00014317
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Contraception
• IUD

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).