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No recruitment occurred and the PI stopped the study
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The investigators study is a prospective randomized trial of women undergoing the levonorgestrel intrauterine system (LNG-IUS: Mirena©, Bayer) at three separate time periods: immediate post placental (IPP) defined as insertion within 10 min delivery of placenta, early post partum (EP) defined as insertion after 10 min but within 72hrs postpartum, or interval (INT) insertion defined as insertion after 6wks postpartum. This is a pilot study in preparation for a multicenter, prospective randomized study of long-acting reversible contraception in the postpartum period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Postplacental | Experimental | Within 10 minutes from delivery of placenta |
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| Early Postpartum | Experimental | After 10 minutes from delivery of placenta but within 48hrs from delivery |
|
| Interval | Experimental | After 6 weeks postpartum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer) | Device | Placement of Mirena at given intervals during the postpartum period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Continuation Rates of the LNG-IUS when placed postpartum at three time periods | Determine if there is a difference in continuation rates at 6 months between participants who had the LNG-IUS placed at three different time periods: Immediate Postplacental (within 10 minutes from delivery of placenta), Early Postpartum (after 10 minutes but before 48 hours postpartum) , and Interval (after 6 weeks postpartum). | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Expulsion rate of the LNG-IUS when placed postpartum at three time periods | Determine if there is a difference in expulsion rates at the three different time periods of placement. | at 3 weeks |
| Pain at placement |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center | Portsmouth | Virginia | 23507 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21843688 | Derived | Dahlke JD, Terpstra ER, Ramseyer AM, Busch JM, Rieg T, Magann EF. Postpartum insertion of levonorgestrel--intrauterine system at three time periods: a prospective randomized pilot study. Contraception. 2011 Sep;84(3):244-8. doi: 10.1016/j.contraception.2011.01.007. Epub 2011 Feb 24. |
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Determine if there is a difference pain as assessed with the Visual Analog Scale at the time of placement of the LNG-IUS at three time period: Immediate Postplacental, Early Postpartum, or Interval.
| at 1 minute |