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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Healthy Device: Levonorgestrel-releasing intrauterine system (LNG-IUS) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arms and Interventions
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Arm Intervention/treatment
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)

 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
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)

 Device: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
Other Name: Mirena IUD


Outcome Measures
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Primary Outcome Measures :
  1. Use of the LNG-IUS for Contraception [ Time Frame: 12 months after cesarean delivery ]

Secondary Outcome Measures :
  1. Rates of Expulsion of the LNG-IUS [ Time Frame: 12 months after cesarean delivery ]
  2. Perforation Rates [ Time Frame: 12 months after cesarean delivery ]
  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00635362


Locations
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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Melissa Gilliam, MD MPH University of Chicago
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Melissa Gilliam, Chief, Section of Family Planning and Contraceptive Research, University of Chicago
ClinicalTrials.gov Identifier: NCT00635362    
Other Study ID Numbers: 15148A
First Posted: March 13, 2008    Key Record Dates
Results First Posted: May 13, 2013
Last Update Posted: May 13, 2013
Last Verified: April 2013
Keywords provided by Melissa Gilliam, University of Chicago:
Contraception
Contraceptive Devices
Intrauterine Devices
Unplanned Pregnancy
Postpartum Period
Additional relevant MeSH terms:
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Levonorgestrel
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
 Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral