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

NCT06042556 | Completed

• 1 other identifier: STUDY00014317
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

IUD; Contraception

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (2)

Guide

EXPERIMENTAL

Randomized to use of our IUD self-removal guide

Other: IUD self-removal guide

No guide

NO INTERVENTION

Randomized to use of no additional resource

Interventions

IUD self-removal guide OTHER

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.

Guide

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 14 and older
• IUD in place and desiring removal
• Interest in attempting self-removal
• English speaking
• Working cell-phone with camera.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Cedar River Clinics

Renton, Washington, 98057, United States

Location

Study Officials

• Kelsey Petrie, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 18, 2023
• Study Start: April 3, 2021
• Primary Completion: February 16, 2023
• Study Completion: February 16, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)