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Trial record 45 of 404 for:    LEVONORGESTREL

Postplacental Insertion of Levonorgestrel-releasing Intrauterine System (LNG-IUS) After Cesarean vs. Interval Insertion

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ClinicalTrials.gov Identifier: NCT00635362
Recruitment Status : Terminated (Low recruitment)
First Posted : March 13, 2008
Results First Posted : May 13, 2013
Last Update Posted : May 13, 2013
Sponsor:
Information provided by (Responsible Party):
Melissa Gilliam, University of Chicago

Tracking Information
First Submitted Date  ICMJE March 5, 2008
First Posted Date  ICMJE March 13, 2008
Results First Submitted Date  ICMJE February 22, 2013
Results First Posted Date  ICMJE May 13, 2013
Last Update Posted Date May 13, 2013
Study Start Date  ICMJE May 2007
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2008)
Use of the LNG-IUS for Contraception [ Time Frame: 12 months after cesarean delivery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00635362 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2013)
  • Rates of Expulsion of the LNG-IUS [ Time Frame: 12 months after cesarean delivery ]
  • Perforation Rates [ Time Frame: 12 months after cesarean delivery ]
  • Satisfaction With LNG-IUS [ Time Frame: 6 months after cesarean delivery ]
    We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being "very unsatisfied," 2 "unsatisfied", 3 "neutral," 4 "satisfied," and 5 "very satisfied." For statistical purposes, subjects were determined to be "SATISFIED" with the IUS if they chose either 4 or 5 for this question.
  • Satisfaction With LNG-IUS [ Time Frame: 12 months after cesarean delivery ]
    We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being "very unsatisfied," 2 "unsatisfied", 3 "neutral," 4 "satisfied," and 5 "very satisfied." For statistical purposes, subjects were determined to be "SATISFIED" with the IUS if they chose either 4 or 5 for this question.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2008)
  • Expulsion rates [ Time Frame: 12 months after cesarean delivery ]
  • Proportion of women able to have LNG-IUS inserted [ Time Frame: 12 months after cesarean delivery ]
  • Perforation Rates [ Time Frame: 12 months after cesarean delivery ]
  • Infection rates [ Time Frame: 12 months after cesarean delivery ]
  • Pregnancy rates [ Time Frame: 12 months after cesarean delivery ]
  • Side effects and satisfaction [ Time Frame: 12 months after cesarean delivery ]
  • Quality of life [ Time Frame: 12 months after cesarean delivery ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postplacental Insertion of Levonorgestrel-releasing Intrauterine System (LNG-IUS) After Cesarean vs. Interval Insertion
Official Title  ICMJE Immediate Post-placental Insertion of the Levonorgestrel-releasing Intrauterine System (LNG-IUS) After Cesarean Delivery vs. 4-8 Week Post-delivery Interval Insertion: A Randomized Controlled Trial
Brief Summary

The study is a randomized controlled trial comparing outcomes of immediate postplacental insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) vs. interval insertion of the LNG-IUS performed 4-8 weeks after delivery for patients undergoing scheduled cesarean delivery.

Our primary hypothesis is that the proportion of women using the LNG-IUS for contraception at 12 months after delivery will be higher in the group randomized to immediate post-placental insertion.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Device: Levonorgestrel-releasing intrauterine system (LNG-IUS)
    Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
    Other Name: Mirena IUD
  • Device: Levonorgestrel-releasing intrauterine system (LNG-IUS)
    Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
    Other Name: Mirena IUD
Study Arms  ICMJE
  • Experimental: postplacental insertion after cesarean

    Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta

    Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)

    Intervention: Device: Levonorgestrel-releasing intrauterine system (LNG-IUS)
  • Active Comparator: delayed insertion group

    Insertion of the LNG-IUS 4-8 weeks after cesarean delivery

    Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)

    Intervention: Device: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Publications * Whitaker AK, Endres LK, Mistretta SQ, Gilliam ML. Postplacental insertion of the levonorgestrel intrauterine device after cesarean delivery vs. delayed insertion: a randomized controlled trial. Contraception. 2014 Jun;89(6):534-9. doi: 10.1016/j.contraception.2013.12.007. Epub 2013 Dec 26.

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: April 1, 2013)
42
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2008)
120
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pregnant at time of enrollment
  • Planning to undergo a scheduled cesarean delivery
  • Desires to use the LNG-IUS for contraception
  • Willing and able to sign an informed consent in English
  • Willing to comply with the study protocol
  • Age greater than or equal to 18 years
  • English speaking

Exclusion Criteria:

  • Allergy to either polyethylene or levonorgestrel, or other contraindications to use of the LNG-IUS
  • Positive testing for Gonorrhea, Chlamydia, or trichomoniasis during the pregnancy without treatment and a subsequent test of cure confirming a negative result
  • Presence of leiomyomata significantly distorting the uterine cavity and thus not allowing placement of the LNG-IUS
  • Uterine anomaly which would not allow placement of the LNG-IUS
  • Current cervical cancer or carcinoma in-situ
  • Desire for repeat pregnancy in less than 12 months
  • History of postabortal or postpartum sepsis
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00635362
Other Study ID Numbers  ICMJE 15148A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Melissa Gilliam, University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Melissa Gilliam, MD MPH University of Chicago
PRS Account University of Chicago
Verification Date April 2013

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