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

Overview

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.

Full Title of Study: “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”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Other
  • Masking: None (Open Label)
• Study Primary Completion Date: February 16, 2023

Interventions

• 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.

Arms, Groups and Cohorts

• Experimental: Guide
  • Randomized to use of our IUD self-removal guide
• No Intervention: No guide
  • Randomized to use of no additional resource

Clinical Trial Outcome Measures

Primary Measures

• Comparison of successful IUD self-removal rates
  • Time Frame: 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).
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 14 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • University of Washington
• Provider of Information About this Clinical Study
  • Principal Investigator: Kelsey Petrie, Clinical Instructor – University of Washington
• Overall Official(s)
  • Kelsey Petrie, MD, MPH, Principal Investigator, University of Washington