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Suspended to determine if Mirena device could be charged to patient insurance
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| Name | Class |
|---|---|
| MaineHealth | OTHER |
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This study aims to demonstrate that the expulsion rate is increased but acceptable when inserting Mirena IUDs immediately postpartum, termed 'postplacental IUD insertion'. The investigators will compare the postplacental insertion expulsion rate estimate with rates reported in the literature for 6 week postpartum insertion, which is currently the American standard for IUD insertion postpartum. Secondary outcomes will also be examined; endometritis, uterine perforation, continuation and pregnancy among others.
The average expulsion rate for 6 week postpartum IUD insertion is approximately 10-12% with a range between 3-20% at 1 year. An acceptable expulsion rate for postplacental insertion (PPI) has not been defined and varies between studies. There are limited data on the expulsion rates of levonorgestrel intrauterine systems. Expulsion rates range widely from 1-3% to as high as 30-40% depending on the IUD and the study. Studies report an average rate of expulsion in ranges approximating 10-12%, similar to 6 week insertion rates.
There are many limitations to published studies including the use of older model IUDs no longer in use, multiple insertion techniques that have been deemed ineffective in reducing expulsion rates as well as varying follow up times making comparison of expulsion rates difficult.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirena IUD Placement Immediately Post-delivery | Experimental | Participants enrolling in this study agree to have the IUD placed immediately post-delivery versus waiting the standard 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel Intrauterine Device | Device | levonorgestrel intrauterine device insertion within ten minutes of placental delivery using a ring forceps insertion protocol |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Expelled IUDs by12 Weeks Postpartum | Number of participants who expelled IUDs by12 weeks postpartum across all participants | up to 12 weeks postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer J Mueller, MD | MaineHealth | Principal Investigator |
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Only 4 subjects were consented out of the 20. Of those 4 only 3 had the IUD inserted.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mirena IUD Placement Immediately Post-delivery | Subjects to have Mirena IUD Placement Immediately Post-delivery |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mirena IUD Placement Immediately Post-delivery | Subjects to have Mirena IUD Placement Immediately Post-delivery |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Expelled IUDs by12 Weeks Postpartum | Number of participants who expelled IUDs by12 weeks postpartum across all participants | Posted | Count of Participants | Participants | up to 12 weeks postpartum |
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12 weeks post IUD placement
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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 | Mirena IUD Placement Immediately Post-delivery | Subjects to have Mirena IUD Placement Immediately Post-delivery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinicaltrials.gov Administrator | MaineHealth | 207.396.8228 | llemire@mmc.org |
Mirena IUD placement
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
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