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The IUB (Intrauterine ball) is a copper releasing intrauterine contraceptive device consisting of copper beads on a flexible NiTinol wire. It was designed to reduce the pain and bleeding caused by traditional T-shaped copper IUDs and to reduce expulsions. In an initial pilot of 15 women, there were no complications during the 12 months. This observational pilot study of 50 women will determine that the early expulsion rate is not greater than 10% and that there is patient and physician acceptance, so that we can plan a larger randomized controlled trial for efficacy and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IUB | Experimental | There is one arm of women who will have IUBs inserted |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IUB | Device | intrauterine contraceptive device |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Expulsion Rate | The device being expelled from the uterus as documented by ultrasound or by seeing the actual device outside the uterus | at 6-8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Complication | infection, perforation, pregnancy | 12 months |
| Acceptability | patient-reported acceptability | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Willow Women's Clinic | Vancouver | British Columbia | V5Z1H9 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | IUB Inserted | There is one arm of women who will have IUBs inserted IUB: intrauterine contraceptive device |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IUB Inserted | There is one arm of women who will have IUBs inserted IUB: intrauterine contraceptive device |
| 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 | Expulsion Rate | The device being expelled from the uterus as documented by ultrasound or by seeing the actual device outside the uterus | Posted | Number | participants | at 6-8 weeks |
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|
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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 | IUB Inserted | There is one arm of women who will have IUBs inserted IUB: intrauterine contraceptive device |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| expulsions | Reproductive system and breast disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Ellen Wiebe | University of British Columbia | 6047095611 | ellenwiebe@gmail.com |
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intrauterine contraceptive device IUB
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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| Secondary | Complication | infection, perforation, pregnancy | Posted | Number | participants | 12 months |
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| Secondary | Acceptability | patient-reported acceptability | Posted | Number | participants | 12 months |
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| 0 |
| 51 |
| 15 |
| 51 |
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