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
Verified date | September 2023 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Cedar River Clinics | Renton | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington |
United States,
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). |
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