Postplacental Mirena IUD Insertion and Estimating Expulsion Rates.

This study has suspended participant recruitment.
(Suspended to determine if Mirena device could be charged to patient insurance)
Sponsor:
Information provided by:
Maine Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01230242
First received: October 28, 2010
Last updated: August 1, 2011
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Estimating Rates of Expulsion
Device: Levonorgestrel Intrauterine Device
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Experimental Study Examining Mirena IUD Insertion and Estimating Rates of Expulsion Immediately After Placental Delivery.

Resource links provided by NLM:


Further study details as provided by Maine Medical Center Research Institute:

Primary Outcome Measures:
  • expulsion of IUD [ Time Frame: at 12 weeks postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • breastfeeding [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • request for IUD removal [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • endometritis [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • uterine perforation [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • pregnancy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 81
Study Start Date: August 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Levonorgestrel Intrauterine Device
    levonorgestrel intrauterine device insertion within ten minutes of placental delivery using a ring forceps insertion protocol
    Other Name: Mirena
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01230242

Sponsors and Collaborators
Maine Medical Center Research Institute
Investigators
Principal Investigator: Jennifer J Mueller, MD Maine Medical Center Research Institute
  More Information

No publications provided

Responsible Party: Jennifer Mueller, MD, Maine Medical Center
ClinicalTrials.gov Identifier: NCT01230242     History of Changes
Other Study ID Numbers: 3689
Study First Received: October 28, 2010
Last Updated: August 1, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Maine Medical Center Research Institute:
Mirena
postplacental intrauterine device
postpartum insertion

Additional relevant MeSH terms:
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on July 22, 2014