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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.
(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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transabdominal Ultrasound Guided IUD Insertion | Procedure | Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Estes, MD | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transabdominal Ultrasound Guided IUD Insertion | Ultrasound Guided IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion |
| FG001 | Traditional Blind IUD Insertion | Traditional Blind IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Four subjects (2 per group) were randomized but unable to insert IUD and therefore were excluded from analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Transabdominal Ultrasound Guided IUD Insertion | Ultrasound Guided IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion |
| BG001 | Traditional Blind IUD Insertion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Had IUD Removed Within 6 Months | IUD discontinuation rates during the 6-month post-insertion period | 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. | Posted | Count of Participants | Participants | 6 Months |
|
Adverse events were collected over the 6-month post-insertion period.
Investigators assessed for adverse events at each visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transabdominal Ultrasound Guided IUD Insertion | Ultrasound Guided IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| malpositioned IUD | Reproductive system and breast disorders | Systematic Assessment | Malpositioned IUD resulting in hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vaginal bleeding | Reproductive system and breast disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Estes, M.D. | The Pennsylvania State Univ College of Medicine, The Milton S. Hershey Medical Center | 717-531-8478 | sestes@pennstatehealth.psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 21, 2020 | Apr 29, 2020 | Prot_SAP_ICF_000.pdf |
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| Traditional Blind IUD Insertion | Procedure | Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion |
|
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 |
Traditional Blind IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Traditional Blind IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | 4-6 Weeks Post Insertion String Check |
|
|
|
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| 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. | All participants for whom IUD was inserted. | Posted | Mean | Standard Deviation | units on a scale | pre and post-insertion (both collected during the insertion visit) |
|
|
|
|
| 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). | Participants who completed the 6m followup visit. | Posted | Count of Participants | Participants | 6 Months |
|
|
|
|
| 0 |
| 40 |
| 1 |
| 40 |
| 19 |
| 40 |
| EG001 | Traditional Blind IUD Insertion | Traditional Blind IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion | 0 | 41 | 0 | 41 | 20 | 41 |
|
| Pelvic Pain | Reproductive system and breast disorders | Systematic Assessment |
|
| Heavy or prolonged menses | Reproductive system and breast disorders | Systematic Assessment |
|
| Hormonal side effects | Reproductive system and breast disorders | Systematic Assessment |
|
| Vaginal dryness | Reproductive system and breast disorders | Systematic Assessment |
|
| Bloating | Reproductive system and breast disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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