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Intrauterine devices (IUDs) are a very effective, long-acting method of contraception. In order to make them accessible to women, health care providers must be trained to insert them. Physicians, physician assistant, and nurse practitioners often learn how to do so by first learning about IUDs, then practicing on a model that the IUD manufacturer provides.
Educators have recently been using more sophisticated models to teach clinical skills such as surgical procedures. We are investigating whether these models may be more useful in teaching IUD insertion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PelvicSim | Active Comparator | Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes. |
|
| Manufacturer model | Placebo Comparator | Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PelvicSim | Other |
| ||
| Manufacturer model |
| Measure | Description | Time Frame |
|---|---|---|
| Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice | Participants were filmed performing 3 IUD insertions each, for three IUDs available in the US. They then practiced on an assigned simulator for 30 minutes, and were re-recorded immediately afterwards. Three months after initial practice, they returned and performed the insertions again. Sets of insertions were scored using a checklist. Participants earned up to 86 points for performing various elements of IUC insertion correctly: sounding the uterus (14 points), and loading as well as inserting the copper device (24 points), levonorgestrel 52mg device (26 points), and levonorgestrel 13.5mg device (22 points). Higher scores were better. | Before and immediately after initial practice on assigned simulator (same day), and three months after initial practice |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Comfort Placing IUDs From Pre- to Post-insertion | Participants were given questionnaires at the initial study visit and at a three-month follow-up visit that assessed their comfort with IUD insertion using a modified Likert scale. | Baseline to three months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siripanth Nippita, MD, MS | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
One participant voluntarily withdrew from the study due to time constraints which precluded completion of the study visit. Therefore, 60 participants enrolled and were randomized, and 59 completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | PelvicSim | Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes. PelvicSim |
| FG001 | Manufacturer Model | Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes. Manufacturer model |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PelvicSim | Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes. PelvicSim |
| BG001 | Manufacturer Model | Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes. Manufacturer model |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice | Participants were filmed performing 3 IUD insertions each, for three IUDs available in the US. They then practiced on an assigned simulator for 30 minutes, and were re-recorded immediately afterwards. Three months after initial practice, they returned and performed the insertions again. Sets of insertions were scored using a checklist. Participants earned up to 86 points for performing various elements of IUC insertion correctly: sounding the uterus (14 points), and loading as well as inserting the copper device (24 points), levonorgestrel 52mg device (26 points), and levonorgestrel 13.5mg device (22 points). Higher scores were better. | Posted | Median | Inter-Quartile Range | Percent of tasks performed correctly | Before and immediately after initial practice on assigned simulator (same day), and three months after initial practice |
|
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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 | PelvicSim | Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes. PelvicSim |
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Participants directed their own practice time. An investigator answered questions but did not provide other feedback unless specifically asked.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Siripanth Nippita | Beth Israel Deaconess Medical Center | 617-667-4165 | snippita@bidmc.harvard.edu |
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|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Occupation | Intern or NP student | Number | participants |
|
| Prior pelvic exams | Number | exams |
|
| Prior IUD insertions performed | Number | exams |
|
Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.
PelvicSim
| OG001 | Manufacturer Model | Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes. Manufacturer model |
|
|
| Secondary | Percent Change in Comfort Placing IUDs From Pre- to Post-insertion | Participants were given questionnaires at the initial study visit and at a three-month follow-up visit that assessed their comfort with IUD insertion using a modified Likert scale. | Posted | Number | Percent change in comfort | Baseline to three months |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Manufacturer Model | Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes. Manufacturer model | 0 | 30 | 0 | 30 |
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| 13.5mg levonorgestrel IUD |
|