A RCT of Ultrasound Guided IUD Insertion

Study Overview
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Brief Summary
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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
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(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.

Official Title
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A Randomized Controlled Trial of Ultrasound-Guided Intrauterine Device (IUD) Insertion

Conditions
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IUD Not Visible

Intervention / Treatment
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* Procedure: Transabdominal Ultrasound Guided IUD Insertion
* Procedure: Traditional Blind IUD Insertion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing IUD Insertion in an Office Setting Fluent in Spoken and Written English Premenopausal Exclusion Criteria: Less than 6 Weeks Postpartum at Time of IUD Insertion Intraoperative IUD Insertion Pregnant Prisoners Cognitive Impairment Unable to Read or Write

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transabdominal Ultrasound Guided IUD Insertion<br>Ultrasound Guided IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion | Procedure: Transabdominal Ultrasound Guided IUD Insertion<br>* Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion<br>|
| Active Comparator: Traditional Blind IUD Insertion<br>Traditional blind IUD insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion | Procedure: Traditional Blind IUD Insertion<br>* Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Had IUD Removed Within 6 Months | IUD discontinuation rates during the 6-month post-insertion period | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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). | 6 Months |