IUD Not VisibleNCT03493815
A RCT of Ultrasound Guided IUD Insertion
A study testing Transabdominal Ultrasound Guided IUD Insertion and Traditional Blind IUD Insertion in people with IUD Not Visible, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
To determine the utility of ultrasound guided IUD insertion compared to the traditional blind insertion at an academic health institute where the skill level of the provider can vary greatly. We hypothesize that ultrasound-guided insertion will lead lower IUD discontinuation rates and greater patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- IUD Not Visible
- What is being tested?
- Transabdominal Ultrasound Guided IUD Insertion and Traditional Blind IUD Insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2018to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergoing IUD Insertion in an Office Setting
- Fluent in Spoken and Written English
- Premenopausal
Who cannot join
- Less than 6 Weeks Postpartum at Time of IUD Insertion
- Intraoperative IUD Insertion
- Pregnant
- Prisoners
- Cognitive Impairment
- Unable to Read or Write
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: A Randomized Controlled Trial of Ultrasound-Guided Intrauterine Device (IUD) Insertion
To determine the utility of ultrasound guided IUD insertion compared to the traditional blind insertion at an academic health institute where the skill level of the provider can vary greatly. We hypothesize that ultrasound-guided insertion will lead lower IUD discontinuation rates and greater patient satisfaction.
Read the detailed description
(Visit 1) All interested women undergoing a scheduled IUD insertion will be screened for inclusion/exclusion criteria by the study coordinator or investigator prior to their clinic visit.
(Visit 2) After meeting eligibility criteria and being consented for the study, a subject will be ready to be randomized. Subject in both groups will fill out a visual analogue score (VAS) before and after the procedure grading their pain. Subjects will be instructed to call the investigator if they experience any abnormal uterine bleeding or problems with their IUD.
Subjects will then be randomized to one of two groups:
Group A: traditional blind IUD insertion. Group B: transabdominal ultrasound guided IUD insertion. Subjects will be randomized to either US guided or traditional placement of IUD using 1:1 allocation. The randomization scheme for this study will use variable-size, random permuted blocks where the variable block sizes are 2,4 and 6.
(Visit 3) Subjects will be scheduled to return to REI clinic 4-6 weeks (Visit 2) after insertion of the IUD as routine follow-up. Subjects will be asked about any adverse events. A routine string check in the form of a speculum exam will be performed in addition to a transvaginal ultrasound to confirm positioning of the IUD. If malposition is determined, then routine care will be to remove the IUD. The ultrasound operator will be blinded to the subject's arm in the study
(Visit 4) At 6 months subjects will be scheduled to return to REI clinic to have an IUD string check and if no strings are visualized then this will be categorized as malposition and the investigator will continue with routine care and work up Subjects who return to clinic for Visit 4 will also have a transvaginal ultrasound performed.
If the subject does not present for a clinic follow up, then she will be contacted by the Study Coordinator or investigator via phone to see if they still have their IUD in place (and when it was removed or lost).
All subjects will be surveyed for pain with the VAS and any adverse events (including abnormal uterine bleeding) will be recorded. All subjects will be asked to categorically rate their satisfaction with the IUD on a Likert Scale.
The total duration of the study is 6 months.
- Conditions
- IUD Not Visible
- Being tested
- Transabdominal Ultrasound Guided IUD Insertion, Traditional Blind IUD Insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transabdominal Ultrasound Guided IUD InsertionProcedure or surgery
Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
Traditional Blind IUD InsertionProcedure or surgery
Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
| Study group | Role | What they receive |
|---|---|---|
| Transabdominal Ultrasound Guided IUD Insertion | Experimental | Ultrasound Guided IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion Receives: Procedure: Transabdominal Ultrasound Guided IUD Insertion |
| Traditional Blind IUD Insertion | Active comparator | Traditional blind IUD insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion Receives: Procedure: Traditional Blind IUD Insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Had IUD Removed Within 6 Months
IUD discontinuation rates during the 6-month post-insertion period
Measured: 6 Months
Secondary outcomes (3)
Number of Participants With Malpositioned IUD at 4-6 Week Visit
String check in the form of a speculum exam in addition to a transvaginal ultrasound to confirm positioning of the IUD
Measured: 4-6 Weeks Post Insertion String Check
Change in Pain Score
Pain was assessed pre and post-insertion with a visual analog scale (VAS) ranging from 0-10 with 0 being no pain and 10 being the worst. Change in pain score was calculated as post minus pre, hence the higher the number, the greater increase in pain.
Measured: pre and post-insertion (both collected during the insertion visit)
Number of Participants Satisfied With IUD at 6 Months
Satisfaction with IUD was initially assessed using a 5-point likert scale where 1=not at all happy and 5=very happy. The likert scale was then collapsed to a binary outcome of satisfied (likert scale scores 4 and 5) vs. not satisfied (likert scale scores 1,2,3).
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start8 Mar 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for IUD Not VisibleStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Estes, Milton S. Hershey Medical Center
- Investigators
- Stephanie Estes, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493815
- Sponsor's protocol ID
- STUDY00008432
- Status last verified
- May 2020
- First submitted
- 26 Mar 2018
- Last updated
- 21 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Ultrasound-Guided Intrauterine Device (IUD) Insertion
- ClinicalTrials.gov ID
- NCT03493815
- Acronym / sponsor ID
- STUDY00008432
- Conditions
- IUD Not Visible
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 11 Apr 2018 (actual)
- Results
- Posted 11 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the utility of ultrasound guided IUD insertion compared to the traditional blind insertion at an academic health institute where the skill level of the provider can vary greatly. We hypothesize that ultrasound-guided insertion will lead lower IUD discontinuation rates and greater patient satisfaction.
Detailed description
(Visit 1) All interested women undergoing a scheduled IUD insertion will be screened for inclusion/exclusion criteria by the study coordinator or investigator prior to their clinic visit.
(Visit 2) After meeting eligibility criteria and being consented for the study, a subject will be ready to be randomized. Subject in both groups will fill out a visual analogue score (VAS) before and after the procedure grading their pain. Subjects will be instructed to call the investigator if they experience any abnormal uterine bleeding or problems with their IUD.
Subjects will then be randomized to one of two groups:
Group A: traditional blind IUD insertion. Group B: transabdominal ultrasound guided IUD insertion. Subjects will be randomized to either US guided or traditional placement of IUD using 1:1 allocation. The randomization scheme for this study will use variable-size, random permuted blocks where the variable block sizes are 2,4 and 6.
(Visit 3) Subjects will be scheduled to return to REI clinic 4-6 weeks (Visit 2) after insertion of the IUD as routine follow-up. Subjects will be asked about any adverse events. A routine string check in the form of a speculum exam will be performed in addition to a transvaginal ultrasound to confirm positioning of the IUD. If malposition is determined, then routine care will be to remove the IUD. The ultrasound operator will be blinded to the subject's arm in the study
(Visit 4) At 6 months subjects will be scheduled to return to REI clinic to have an IUD string check and if no strings are visualized then this will be categorized as malposition and the investigator will continue with routine care and work up Subjects who return to clinic for Visit 4 will also have a transvaginal ultrasound performed.
If the subject does not present for a clinic follow up, then she will be contacted by the Study Coordinator or investigator via phone to see if they still have their IUD in place (and when it was removed or lost).
All subjects will be surveyed for pain with the VAS and any adverse events (including abnormal uterine bleeding) will be recorded. All subjects will be asked to categorically rate their satisfaction with the IUD on a Likert Scale.
The total duration of the study is 6 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transabdominal Ultrasound Guided IUD Insertion | Experimental | Procedure: Transabdominal Ultrasound Guided IUD InsertionUltrasound Guided IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion |
| Traditional Blind IUD Insertion | Active comparator | Procedure: Traditional Blind IUD InsertionTraditional blind IUD insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing IUD Insertion in an Office Setting
- Fluent in Spoken and Written English
- Premenopausal
Key exclusion criteria (6 listed)
- Less than 6 Weeks Postpartum at Time of IUD Insertion
- Intraoperative IUD Insertion
- Pregnant
- Prisoners
- Cognitive Impairment
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 |
|---|---|---|
| Transabdominal Ultrasound Guided IUD InsertionComparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion | Procedure or surgery | Transabdominal Ultrasound Guided IUD Insertion |
| Traditional Blind IUD InsertionComparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion | Procedure or surgery | Traditional Blind IUD Insertion |
Primary outcome
Number of Participants Who Had IUD Removed Within 6 Months
Time frame: 6 Months
IUD discontinuation rates during the 6-month post-insertion period
3 secondary outcomes
Number of Participants With Malpositioned IUD at 4-6 Week Visit
Time frame: 4-6 Weeks Post Insertion String Check
Change in Pain Score
Time frame: pre and post-insertion (both collected during the insertion visit)
Number of Participants Satisfied With IUD at 6 Months
Time frame: 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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.
Stephanie Estes, MD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transabdominal Ultrasound Guided IUD Insertion and Traditional Blind IUD Insertion in people with IUD Not Visible, run by Milton S. Hershey 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 6 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 21 May 2020. 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?
Yes. Results are posted in the registry (first posted 11 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Had IUD Removed Within 6 Months (time frame: 6 Months). 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 21 May 2020.