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Trial record 41 of 403 for:    LEVONORGESTREL

Postplacental Mirena IUD Insertion and Estimating Expulsion Rates.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01230242
Recruitment Status : Suspended (Suspended to determine if Mirena device could be charged to patient insurance)
First Posted : October 29, 2010
Last Update Posted : August 2, 2011
Sponsor:
Information provided by:
Maine Medical Center Research Institute

Tracking Information
First Submitted Date  ICMJE October 28, 2010
First Posted Date  ICMJE October 29, 2010
Last Update Posted Date August 2, 2011
Study Start Date  ICMJE August 2010
Estimated Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2010)
expulsion of IUD [ Time Frame: at 12 weeks postpartum ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01230242 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2010)
  • breastfeeding [ Time Frame: 12 weeks ]
  • request for IUD removal [ Time Frame: 12 weeks ]
  • endometritis [ Time Frame: 12 weeks ]
  • uterine perforation [ Time Frame: 12 weeks ]
  • pregnancy [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postplacental Mirena IUD Insertion and Estimating Expulsion Rates.
Official Title  ICMJE Experimental Study Examining Mirena IUD Insertion and Estimating Rates of Expulsion Immediately After Placental Delivery.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Estimating Rates of Expulsion
Intervention  ICMJE Device: Levonorgestrel Intrauterine Device
levonorgestrel intrauterine device insertion within ten minutes of placental delivery using a ring forceps insertion protocol
Other Name: Mirena
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: October 28, 2010)
81
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2012
Estimated Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01230242
Other Study ID Numbers  ICMJE 3689
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jennifer Mueller, MD, Maine Medical Center
Study Sponsor  ICMJE Maine Medical Center Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jennifer J Mueller, MD Maine Medical Center Research Institute
PRS Account Maine Medical Center Research Institute
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP