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Postplacental Mirena IUD Insertion and Estimating Expulsion Rates.

Information source: Maine Medical Center Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Estimating Rates of Expulsion

Intervention: Levonorgestrel Intrauterine Device (Device)

Phase: Phase 4

Status: Suspended

Sponsored by: Maine Medical Center Research Institute

Official(s) and/or principal investigator(s):
Jennifer J Mueller, MD, Principal Investigator, Affiliation: Maine Medical Center Research Institute

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.

Clinical Details

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

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: expulsion of IUD

Secondary outcome:

breastfeeding

request for IUD removal

endometritis

uterine perforation

pregnancy

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: August 2010
Last updated: August 1, 2011

Page last updated: August 23, 2015

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