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Trial record 48 of 404 for:    LEVONORGESTREL

Mirena Intrauterine System Timing of Insertion: A Randomized Controlled Trial (MISTIC)

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ClinicalTrials.gov Identifier: NCT01272960
Recruitment Status : Completed
First Posted : January 10, 2011
Results First Posted : December 2, 2017
Last Update Posted : December 2, 2017
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE January 6, 2011
First Posted Date  ICMJE January 10, 2011
Results First Submitted Date  ICMJE May 16, 2016
Results First Posted Date  ICMJE December 2, 2017
Last Update Posted Date December 2, 2017
Study Start Date  ICMJE October 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2011)
Mirena in Place [ Time Frame: 6 months ]
Proportion of women in each arm with Mirena in place at 6 months
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01272960 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2011)
  • Mirena Expulsion [ Time Frame: 6 weeks ]
    The percentage of patients with post-placental placement of Mirena who experience an expulsion
  • Uterine Perforation [ Time Frame: 6 months ]
    The proportion of patients in each arm who experience a uterine perforation
  • Intrauterine Infection [ Time Frame: 6 months ]
    The proportion of patients in each arm who experience an intrauterine infection (endometritis, pelvic inflammatory disease)
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 Mirena Intrauterine System Timing of Insertion: A Randomized Controlled Trial
Official Title  ICMJE Randomized, Open-label, Controlled Trial of Immediate Postpartum Versus Interval Insertion of Mirena to Increase the Usage at 6 Months After Delivery
Brief Summary

In order to determine the timing of LNG-IUS insertion that results in a greater proportion of women using the LNG-IUS at 6-months post-partum, we will perform a randomized control trial of interval versus immediate post-placenta insertion. Women will be enrolled at 36-weeks gestation and greater. At the time of vaginal delivery, women will be randomized to receive either immediate post-placenta insertion of the LNG-IUS or routine insertion at 4-8 weeks post-partum. All patients will return at 4-6 weeks post-insertion and 6 months post-partum to confirm correct position of the LNG-IUS. The primary outcome of this sub-study is the number of LNG-IUS in the correct position at 6-months. Secondary outcomes include assessing the safety of post-placental LNG-IUS insertion and difference in acceptability and symptoms experienced by participants. This is a sub-study of the Contraceptive Choice Project, a prospective cohort study that aims to improve the use of long-acting contraception by removing financial barriers which has already enrolled over 5,000 patients. Association of this study with CHOICE offers unique advantages including infrastructure to support subject recruitment, retention and completion of follow-up as well as covering the cost of LNG-IUS devices.

We hypothesize that, despite higher expulsion rates, women randomized to receive the LNG-IUS immediately after placenta delivery will have higher rates of LNG-IUS continuation due to poor rates of follow up in the interval insertion group. This is likely to be particularly noticeable in our patient population, which is largely uninsured with poor access to healthcare. Further, typical symptoms of LNG-IUS insertion include bleeding and cramping, which may be disguised by the post-partum period. Published reports of immediate post-placenta insertion focus on expulsion rates and do not report on symptoms and satisfaction rates.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Postpartum Period
Intervention  ICMJE
  • Device: Post-Placenta Mirena Insertion
    Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta
  • Device: Interval Insertion
    Insertion of Mirena 4-8 weeks post partum after vaginal delivery
Study Arms  ICMJE
  • Active Comparator: Interval Insertion
    Will receive Mirena at 4-8 weeks post-partum after vaginal delivery.
    Intervention: Device: Interval Insertion
  • Experimental: Post-Placental Mirena Insertion
    Will receive Mirena insertion within 10 minutes of delivery of placenta
    Intervention: Device: Post-Placenta Mirena Insertion
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2012)
53
Original Estimated Enrollment  ICMJE
 (submitted: January 7, 2011)
194
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 14-45 years
  • Vaginal Delivery at Barnes-Jewish Hospital
  • Sexually active with male partner
  • No tubal ligation/hysterectomy
  • Not currently using contraception
  • Desire reversible contraception
  • Reside in St. Louis City/County
  • Requests Mirena(R) intrauterine device for contraception

Exclusion Criteria:

  • Allergy to Mirena(R) system
  • Cesarean delivery
  • Cervical cancer, breast cancer
  • Active liver disease
  • Untreated cervicitis
  • Uterine anomaly/fibroids preventing Mirena(R) placement
  • Delivery <36 weeks
  • Chorioamnionitis
  • Prolonged rupture of membranes (>18 hours)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 14 Years to 45 Years   (Child, 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 NCT01272960
Other Study ID Numbers  ICMJE SFP4-13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Society of Family Planning
Investigators  ICMJE
Principal Investigator: Lorie M Harper, MD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date October 2017

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