IUD Not Visible
Conditions
Brief 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.
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.
Interventions
PROCEDURETransabdominal Ultrasound Guided IUD Insertion
Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
PROCEDURETraditional Blind IUD Insertion
Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had IUD Removed Within 6 Months | 6 Months | IUD discontinuation rates during the 6-month post-insertion period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Malpositioned IUD at 4-6 Week Visit | 4-6 Weeks Post Insertion String Check | String check in the form of a speculum exam in addition to a transvaginal ultrasound to confirm positioning of the IUD |
| Change in Pain Score | pre and post-insertion (both collected during the insertion visit) | 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. |
| Number of Participants Satisfied With IUD at 6 Months | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transabdominal Ultrasound Guided IUD Insertion Ultrasound Guided IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion | 40 |
| Traditional Blind IUD Insertion Traditional Blind IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion | 41 |
| Total | 81 |
Baseline characteristics
| Characteristic | Total | Transabdominal Ultrasound Guided IUD Insertion | Traditional Blind IUD Insertion |
|---|---|---|---|
| Age, Continuous | 31.1 years STANDARD_DEVIATION 7 | 30.7 years STANDARD_DEVIATION 6.2 | 31.5 years STANDARD_DEVIATION 7.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 5 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 70 Participants | 35 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White vs. non-white Non-white | 11 Participants | 5 Participants | 6 Participants |
| Race/Ethnicity, Customized White vs. non-white White | 70 Participants | 35 Participants | 35 Participants |
| Sex: Female, Male Female | 81 Participants | 40 Participants | 41 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 41 |
| other Total, other adverse events | 19 / 40 | 20 / 41 |
| serious Total, serious adverse events | 1 / 40 | 0 / 41 |
Outcome results
Primary
Number of Participants Who Had IUD Removed Within 6 Months
IUD discontinuation rates during the 6-month post-insertion period
Time frame: 6 Months
Population: Participants who had an IUD inserted and either discontinued the IUD or continued the IUD until the 6m visit were included. Participants who were lost to followup (outcome unknown) were excluded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transabdominal Ultrasound Guided IUD Insertion | Number of Participants Who Had IUD Removed Within 6 Months | 6 Participants |
| Traditional Blind IUD Insertion | Number of Participants Who Had IUD Removed Within 6 Months | 8 Participants |
p-value: 0.5195% CI: [0.28, 1.9]binary regression w/ comp log-log link
Secondary
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.
Time frame: pre and post-insertion (both collected during the insertion visit)
Population: All participants for whom IUD was inserted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transabdominal Ultrasound Guided IUD Insertion | Change in Pain Score | 2.3 units on a scale | Standard Deviation 2.5 |
| Traditional Blind IUD Insertion | Change in Pain Score | 2.1 units on a scale | Standard Deviation 2 |
p-value: 0.76t-test, 2 sided
Secondary
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).
Time frame: 6 Months
Population: Participants who completed the 6m followup visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transabdominal Ultrasound Guided IUD Insertion | Number of Participants Satisfied With IUD at 6 Months | 24 Participants |
| Traditional Blind IUD Insertion | Number of Participants Satisfied With IUD at 6 Months | 21 Participants |
p-value: 0.7Fisher Exact
Secondary
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
Time frame: 4-6 Weeks Post Insertion String Check
Population: This analysis includes participants active in the study at the 4-6 week visit. Study participants who discontinued their IUD prior to this visit, or who were lost to followup prior to this visit, were excluded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transabdominal Ultrasound Guided IUD Insertion | Number of Participants With Malpositioned IUD at 4-6 Week Visit | 3 Participants |
| Traditional Blind IUD Insertion | Number of Participants With Malpositioned IUD at 4-6 Week Visit | 6 Participants |
p-value: 0.4195% CI: [0.15, 2.18]binary regression w/ comp log-log link