IUDNCT06042556
IUD Self-Removal: Evaluating an Online Guide for Self-removal in Clinical and Non-clinical Settings
A study testing IUD self-removal guide in people with IUD and Contraception, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- IUD, Contraception
- What is being tested?
- IUD self-removal guide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2021to 16 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Ages 14 and older
- IUD in place and desiring removal
- Interest in attempting self-removal
- English speaking
- Working cell-phone with camera.
Who cannot join
- Not meeting above inclusion criteria, no other specific exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
Read more
-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
- Being tested
- IUD self-removal guide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IUD self-removal guideOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Guide | Experimental | Randomized to use of our IUD self-removal guide Receives: Other: IUD self-removal guide |
| No guide | No intervention | Randomized to use of no additional resource |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start3 Apr 2021
- Primary completion16 Feb 2023
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IUDStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelsey Petrie, University of Washington
- Investigators
- Kelsey Petrie, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042556
- Sponsor's protocol ID
- STUDY00014317
- Status last verified
- Sep 2023
- First submitted
- 8 Sep 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06042556
- Acronym / sponsor ID
- STUDY00014317
- Conditions
- IUD, Contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 3 Apr 2021 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guide | Experimental | Other: IUD self-removal guideRandomized to use of our IUD self-removal guide |
| No guide | No intervention | –Randomized to use of no additional resource |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Ages 14 and older
- IUD in place and desiring removal
- Interest in attempting self-removal
- English speaking
- Working cell-phone with camera.
Key exclusion criteria (1 listed)
- Not meeting above inclusion criteria, no other specific exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IUD self-removal guideWe 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. | Other | Guide |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for IUD
Active, not recruitingPhase 4
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
Malaria,Falciparum, Malaria in Pregnancy
Active, not recruitingPhase 2
Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer
Atypical Endometrial Hyperplasia, Stage I Uterine Corpus Cancer AJCC v7
RecruitingObservational study
Postprandial Glucose Handing in Contraceptive and IUD Users
Glucose Homeostasis
RecruitingObservational study
Primitive Immunodeficiency, Intrauterine Devices and Menstrual Hygiene Products
Primary Immune Deficiency Diseases
RecruitingPhase 2
A Study to Estimate Early Clinical Efficacy Signals of GLP-1 Agonist Administration in Conjunction With Levonorgestrel Intrauterine Device in Obese Patients With Endometrioid Intraepithelial Neoplasia
Endometrioid Endometrial Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelsey Petrie, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IUD self-removal guide in people with IUD and Contraception, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.