Postplacental Mirena IUD Insertion and Estimating Expulsion Rates.
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|ClinicalTrials.gov Identifier: NCT01230242|
Recruitment Status : Suspended (Suspended to determine if Mirena device could be charged to patient insurance)
First Posted : October 29, 2010
Last Update Posted : August 2, 2011
|Condition or disease||Intervention/treatment||Phase|
|Estimating Rates of Expulsion||Device: Levonorgestrel Intrauterine Device||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||81 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Experimental Study Examining Mirena IUD Insertion and Estimating Rates of Expulsion Immediately After Placental Delivery.|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||August 2012|
|Estimated Study Completion Date :||August 2012|
- Device: Levonorgestrel Intrauterine Device
levonorgestrel intrauterine device insertion within ten minutes of placental delivery using a ring forceps insertion protocolOther Name: Mirena
- expulsion of IUD [ Time Frame: at 12 weeks postpartum ]
- breastfeeding [ Time Frame: 12 weeks ]
- request for IUD removal [ Time Frame: 12 weeks ]
- endometritis [ Time Frame: 12 weeks ]
- uterine perforation [ Time Frame: 12 weeks ]
- pregnancy [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230242
|Principal Investigator:||Jennifer J Mueller, MD||Maine Medical Center Research Institute|