Postplacental Mirena IUD Insertion and Estimating Expulsion Rates.

Rebecca Hunt

Status: Terminated

Conditions: Estimating Rates of Expulsion

Treatments: Device: Levonorgestrel Intrauterine Device

Study type: Interventional

Funder types: Other

Identifiers

NCT01230242

3689

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Mirena IUD Placement Immediately Post-delivery

Experimental group

Description:

Participants enrolling in this study agree to have the IUD placed immediately post-delivery versus waiting the standard 6 weeks.

Treatment:

Device: Levonorgestrel Intrauterine Device