Postplacental Mirena IUD Insertion and Estimating Expulsion Rates.

Not Applicable

Terminated

• Conditions: Estimating Rates of Expulsion
• Interventions: Device: Levonorgestrel Intrauterine Device

• Registration Number: NCT01230242
• Lead Sponsor: Rebecca Hunt

Brief Summary

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

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 Timeline

• Study Start: 2010-09-07
• Primary Completion: 2010-10-27
• Study First Submitted: 2010-10-28
• Study First Submitted QC: 2010-10-28
• Study First Posted: 2010-10-29
• Study Completion: 2011-07-26
• Results First Submitted: 2021-08-30
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-16
• Last Update Submitted: 2021-12-16
• Results First Posted: 2021-12-17
• Last Update Posted: 2021-12-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mirena IUD Placement Immediately Post-delivery	Levonorgestrel Intrauterine Device	Participants enrolling in this study agree to have the IUD placed immediately post-delivery versus waiting the standard 6 weeks.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Expelled IUDs by12 Weeks Postpartum	up to 12 weeks postpartum	Number of participants who expelled IUDs by12 weeks postpartum across all participants