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

This study has been completed.
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01272960
First received: January 6, 2011
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Postpartum Period
Device: Post-Placenta Mirena Insertion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized, Open-label, Controlled Trial of Immediate Postpartum Versus Interval Insertion of Mirena to Increase the Usage at 6 Months After Delivery

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Mirena in place [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Proportion of women in each arm with Mirena in place at 6 months


Secondary Outcome Measures:
  • Mirena expulsion [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The percentage of patients with post-placental placement of Mirena who experience an expulsion

  • Uterine perforation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The proportion of patients in each arm who experience a uterine perforation

  • Intrauterine infection [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The proportion of patients in each arm who experience an intrauterine infection (endometritis, pelvic inflammatory disease)


Enrollment: 53
Study Start Date: October 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Interval Insertion
Will receive Mirena at 4-8 weeks post-partum after vaginal delivery.
Device: Post-Placenta Mirena Insertion
Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta
Experimental: Post-Placental Mirena Insertion
Will receive Mirena insertion within 10 minutes of delivery of placenta
Device: Post-Placenta Mirena Insertion
Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta

  Eligibility

Ages Eligible for Study:   14 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
  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: NCT01272960

Locations
United States, Missouri
Barnes Jewish Hospital
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Society of Family Planning
Investigators
Principal Investigator: Lorie M Harper, MD Washington University School of Medicine
  More Information

Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01272960     History of Changes
Other Study ID Numbers: SFP4-13
Study First Received: January 6, 2011
Last Updated: May 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Contraception
Postnatal care

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

ClinicalTrials.gov processed this record on November 27, 2014