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

September 14, 2023 updated by: Kelsey Petrie, University of Washington

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Renton, Washington, United States, 98057
        • Cedar River Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Guide
Randomized to use of our IUD self-removal guide
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.
No Intervention: No guide
Randomized to use of no additional resource

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Investigators

  • Principal Investigator: Kelsey Petrie, MD, MPH, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2021

Primary Completion (Actual)

February 16, 2023

Study Completion (Actual)

February 16, 2023

Study Registration Dates

First Submitted

September 8, 2023

First Submitted That Met QC Criteria

September 14, 2023

First Posted (Actual)

September 18, 2023

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00014317

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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