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