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Postplacental Mirena IUD Insertion and Estimating Expulsion Rates.

NCT ID: NCT01230242

Last Updated: 2021-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-07

Study Completion Date

2011-07-26

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.

Conditions

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Estimating Rates of Expulsion

Keywords

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Mirena postplacental intrauterine device postpartum insertion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Mirena IUD placement
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mirena IUD Placement Immediately Post-delivery

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

Group Type EXPERIMENTAL

Levonorgestrel Intrauterine Device

Intervention Type DEVICE

levonorgestrel intrauterine device insertion within ten minutes of placental delivery using a ring forceps insertion protocol

Interventions

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Levonorgestrel Intrauterine Device

levonorgestrel intrauterine device insertion within ten minutes of placental delivery using a ring forceps insertion protocol

Intervention Type DEVICE

Other Intervention Names

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Mirena

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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MaineHealth

OTHER

Sponsor Role collaborator

Rebecca Hunt

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Hunt

Physician, MMP Women's Health Maternal-Fetal Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jennifer J Mueller, MD

Role: PRINCIPAL_INVESTIGATOR

MaineHealth

Countries

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United States

Other Identifiers

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3689

Identifier Type: -

Identifier Source: org_study_id