Postplacental Mirena IUD Insertion and Estimating Expulsion Rates.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Experimental Study Examining Mirena IUD Insertion and Estimating Rates of Expulsion Immediately After Placental Delivery.

Conditions
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Estimating Rates of Expulsion

Intervention / Treatment
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* Device: Levonorgestrel Intrauterine Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 or greater obstetric patient in greater Portland, ME area Exclusion Criteria: Evidence of chorioamnionitis (persistent fetal tachycardia, intra-partum fever >38.0) prolonged rupture of membranes (greater than 24 hours) intrauterine fetal demise use of general anesthesia at time of delivery postpartum hemorrhage (>500ml vaginal, >1000ml cesarean) magnesium administration in labor due to HELLP syndrome or preeclampsia preterm delivery.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Mirena IUD placement
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mirena IUD Placement Immediately Post-delivery<br>Participants enrolling in this study agree to have the IUD placed immediately post-delivery versus waiting the standard 6 weeks. | Device: Levonorgestrel Intrauterine Device<br>* levonorgestrel intrauterine device insertion within ten minutes of placental delivery using a ring forceps insertion protocol<br>* Other names: Mirena;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mirena, postplacental intrauterine device, postpartum insertion