IUD RemovalNCT05191238
Intrauterine Device (IUD) Self Removal
A study testing IUD self-removal education in people with IUD Removal, run by Boston Medical Center at 1 site in United States.
Trial summary
This pilot research study will teach patients how to self-remove intrauterine contraceptive device (IUD) through an educational video and simulation and evaluate patient perspectives and experiences related to IUD self-removal with two surveys. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- IUD Removal
- What is being tested?
- IUD self-removal education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2022to 12 Dec 2022
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English or Spanish speaking
- Present to Boston Medical Center Yawkey for removal of IUD and have been consented for removal
- Are eligible for removal of IUD in the office setting
Who cannot join
- Current incarceration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patients Pull the Strings: A Pilot Study of IUD Self-Removal Simulation
This pilot research study will teach patients how to self-remove intrauterine contraceptive device (IUD) through an educational video and simulation and evaluate patient perspectives and experiences related to IUD self-removal with two surveys. Patients will be recruited for this study at the time of presentation to the office for IUD removal. After consenting to the procedure, participants will complete a pre-intervention survey, watch a video explaining how to self-remove the IUD, and use two models to simulate IUD removal. After completion of using the models to practice IUD removal, participants will complete a second short survey. The participant will then be given the option of attempting self-removal and be given time to attempt the removal. If the participant elects to have the provider remove their IUD, the provider will do so. At the end of the encounter, participants will fill out a final survey. Research staff will measure the length of the strings of all IUDs prior to routine disposal of the device.
- Conditions
- IUD Removal
- Being tested
- IUD self-removal education
- Keywords
- Self removal of IUD, Educational video, Simulation, Patient education, Intrauterine device, Contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IUD self-removal educationOther
Two part educational intervention (watching IUD self-removal video and practicing IUD removal on two simulation models)
| Study group | Role | What they receive |
|---|---|---|
| Participants consented for IUD removal | Experimental | Participants will be shown an educational video about IUD self-removal and simulation models. After the video, participants will be given the choice to either attempt IUD self-removal or to have their provider perform standard removal. If a participant elects to attempt self-removal and fails, their provider will offer standard removal. Receives: Other: IUD self-removal education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in proportion of participants who are willing to attempt IUD self-removal
Participants will be asked before and after reviewing the educational video and practicing self-removal through simulation, if they are willing to attempt IUD self-removal. The change in the proportion willing to attempt IUD self-removal will be calculated.
Measured: baseline, 15-30 minutes
Proportion of participants who attempt IUD self-removal
Attempt Yes/No
Measured: 15-30 minutes
Secondary outcomes (1)
Success of IUD self removal
Success Yes/No
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start22 Feb 2022
- Primary completion12 Dec 2022
- Study completion12 Dec 2022
Why it stopped: The study was terminated because of difficulty recruiting participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IUD RemovalStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor
- Investigators
- Melissa Wong, MD, Principal investigator, Boston Medical Center, Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191238
- Sponsor's protocol ID
- H-42042
- Status last verified
- Dec 2023
- First submitted
- 29 Dec 2021
- Last updated
- 22 Dec 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 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients Pull the Strings: A Pilot Study of IUD Self-Removal Simulation
- ClinicalTrials.gov ID
- NCT05191238
- Acronym / sponsor ID
- H-42042
- Conditions
- IUD Removal
- Keywords
- Self removal of IUD, Educational video, Simulation, Patient education, Intrauterine device, Contraception
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated because of difficulty recruiting participants.
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 13 Jan 2022 (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.
This pilot research study will teach patients how to self-remove intrauterine contraceptive device (IUD) through an educational video and simulation and evaluate patient perspectives and experiences related to IUD self-removal with two surveys. Patients will be recruited for this study at the time of presentation to the office for IUD removal. After consenting to the procedure, participants will complete a pre-intervention survey, watch a video explaining how to self-remove the IUD, and use two models to simulate IUD removal. After completion of using the models to practice IUD removal, participants will complete a second short survey. The participant will then be given the option of attempting self-removal and be given time to attempt the removal. If the participant elects to have the provider remove their IUD, the provider will do so. At the end of the encounter, participants will fill out a final survey. Research staff will measure the length of the strings of all IUDs prior to routine disposal of the device.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants consented for IUD removal | Experimental | Other: IUD self-removal educationParticipants will be shown an educational video about IUD self-removal and simulation models. After the video, participants will be given the choice to either attempt IUD self-removal or to have their provider perform standard removal. If a participant elects to attempt self-removal and fails, their provider will offer standard removal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English or Spanish speaking
- Present to Boston Medical Center Yawkey for removal of IUD and have been consented for removal
- Are eligible for removal of IUD in the office setting
Key exclusion criteria (1 listed)
- Current incarceration
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 educationTwo part educational intervention (watching IUD self-removal video and practicing IUD removal on two simulation models) | Other | Participants consented for IUD removal |
Primary outcome
Change in proportion of participants who are willing to attempt IUD self-removal
Time frame: baseline, 15-30 minutes
Participants will be asked before and after reviewing the educational video and practicing self-removal through simulation, if they are willing to attempt IUD self-removal. The change in the proportion willing to attempt IUD self-removal will be calculated.
Proportion of participants who attempt IUD self-removal
Time frame: 15-30 minutes
Attempt Yes/No
1 secondary outcome
Success of IUD self removal
Time frame: 1 day
Results and safety
The study was stopped early (reason given: The study was terminated because of difficulty recruiting participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for IUD Removal
Recruiting
PLACE Trial: Preserving Long-Acting Contraception Through Education
Contraception
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.
Melissa Wong, MD principal investigator
Boston Medical Center, Obstetrics and Gynecology
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 education in people with IUD Removal, run by Boston Medical Center 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 3 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: stopped early, as of the sponsor's last update on 22 Dec 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 was stopped early (reason given: The study was terminated because of difficulty recruiting participants.). Results are not available in the source record.
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?
Change in proportion of participants who are willing to attempt IUD self-removal (time frame: baseline, 15-30 minutes). The study lists 2 primary outcomes in all. 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 22 Dec 2023.