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Levonorgestrel-Intrauterine System (LNG-IUS) Insertion in the Postpartum Period

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by United States Naval Medical Center, Portsmouth.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
United States Naval Medical Center, Portsmouth
ClinicalTrials.gov Identifier:
NCT01088178
First received: February 25, 2010
Last updated: September 29, 2010
Last verified: September 2010

February 25, 2010
September 29, 2010
November 2009
May 2010   (final data collection date for primary outcome measure)
Continuation Rates of the LNG-IUS when placed postpartum at three time periods [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
Determine if there is a difference in continuation rates at 6 months between participants who had the LNG-IUS placed at three different time periods: Immediate Postplacental (within 10 minutes from delivery of placenta), Early Postpartum (after 10 minutes but before 48 hours postpartum) , and Interval (after 6 weeks postpartum).
Same as current
Complete list of historical versions of study NCT01088178 on ClinicalTrials.gov Archive Site
  • Expulsion rate of the LNG-IUS when placed postpartum at three time periods [ Time Frame: at 3 weeks ] [ Designated as safety issue: No ]
    Determine if there is a difference in expulsion rates at the three different time periods of placement.
  • Pain at placement [ Time Frame: at 1 minute ] [ Designated as safety issue: No ]
    Determine if there is a difference pain as assessed with the Visual Analog Scale at the time of placement of the LNG-IUS at three time period: Immediate Postplacental, Early Postpartum, or Interval.
Same as current
Not Provided
Not Provided
 
Levonorgestrel-Intrauterine System (LNG-IUS) Insertion in the Postpartum Period
Levonorgestrel-Intrauterine System (LNG-IUS) Insertion in the Postpartum Period: A Prospective, Randomized Pilot Study of Three Time Intervals

The investigators study is a prospective randomized trial of women undergoing the levonorgestrel intrauterine system (LNG-IUS: Mirena©, Bayer) at three separate time periods: immediate post placental (IPP) defined as insertion within 10 min delivery of placenta, early post partum (EP) defined as insertion after 10 min but within 72hrs postpartum, or interval (INT) insertion defined as insertion after 6wks postpartum. This is a pilot study in preparation for a multicenter, prospective randomized study of long-acting reversible contraception in the postpartum period.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Contraception
Device: Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)
Placement of Mirena at given intervals during the postpartum period
  • Experimental: Immediate Postplacental
    Within 10 minutes from delivery of placenta
    Intervention: Device: Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)
  • Experimental: Early Postpartum
    After 10 minutes from delivery of placenta but within 48hrs from delivery
    Intervention: Device: Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)
  • Experimental: Interval
    After 6 weeks postpartum
    Intervention: Device: Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)
Dahlke JD, Terpstra ER, Ramseyer AM, Busch JM, Rieg T, Magann EF. Postpartum insertion of levonorgestrel--intrauterine system at three time periods: a prospective randomized pilot study. Contraception. 2011 Sep;84(3):244-8. doi: 10.1016/j.contraception.2011.01.007. Epub 2011 Feb 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
July 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All reproductive age women who express a desire for the LNG-IUS (Mirena©) at routine questioning at their 36-38 week prenatal appointment or upon admission to labor and delivery are eligible for our study.

Exclusion Criteria:

  • Contraindications to the LNG-IUS include: Pregnancy or suspicion of pregnancy, Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity, Postpartum endometritis within the past 3 months, Known or suspected uterine or cervical neoplasia or unresolved, abnormal pap smear, untreated acute cervicitis or vaginitis including bacterial vaginosis or other lower genital tract infections, acute liver disease or liver tumor, hypersensitivity to any component of the product, known or suspected carcinoma of the breast. Any of these conditions would exclude the patient from our study.
  • Delivery <36 weeks
  • Intrapartum chorioamnionitis (defined as maternal fever >100.4 and two of the following conditions: Maternal leukocytosis (greater than 15,000 cells/cubic millimeter), Maternal tachycardia (greater than 100 beats/minute), Fetal tachycardia (greater than 160 beats/minute), Uterine tenderness, Foul odor of the amniotic fluid
  • Postpartum Hemorrhage (defined as >500cc EBL for spontaneous vaginal delivery)
  • Cesarean delivery if randomized to IPP or EP placement
Female
16 Years to 45 Years
No
Contact: Joshua D Dahlke, MD 757-953-4503 joshua.dahlke@med.navy.mil
United States
 
NCT01088178
NMCP.2009.0062
Yes
LCDR Joshua D. Dahlke MD, Naval Medical Center Portsmouth Virginia
United States Naval Medical Center, Portsmouth
Not Provided
Not Provided
United States Naval Medical Center, Portsmouth
September 2010

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