- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01230242
Postplacental Mirena IUD Insertion and Estimating Expulsion Rates.
Experimental Study Examining Mirena IUD Insertion and Estimating Rates of Expulsion Immediately After Placental Delivery.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
levonorgestrel intrauterine device insertion within ten minutes of placental delivery using a ring forceps insertion protocol
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Expelled IUDs by12 Weeks Postpartum
Time Frame: up to 12 weeks postpartum
|
Number of participants who expelled IUDs by12 weeks postpartum across all participants
|
up to 12 weeks postpartum
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer J Mueller, MD, MaineHealth
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3689
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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