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BLIS - Breastfeeding Levonorgestrel IUD Study (BLIS)

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ClinicalTrials.gov Identifier: NCT01990703
Recruitment Status : Completed
First Posted : November 21, 2013
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborators:
Society of Family Planning
University of New Mexico
Information provided by (Responsible Party):
David Turok, University of Utah

Tracking Information
First Submitted Date  ICMJE November 15, 2013
First Posted Date  ICMJE November 21, 2013
Results First Submitted Date  ICMJE March 27, 2017
Results First Posted Date  ICMJE June 14, 2017
Last Update Posted Date June 14, 2017
Study Start Date  ICMJE January 2014
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2013)
Breastfeeding Continuation Rates at 8 Weeks Postpartum [ Time Frame: 8 weeks postpartum ]
To determine breastfeeding continuation rates at 8 weeks in women randomized to immediate post-placental vs. delayed (4-8 weeks) postpartum levonorgestrel IUD insertion.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01990703 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2017)
Time to Lactogenesis Stage 2 [ Time Frame: First 5 days after birth ]
To evaluate potential delay in lactogenesis caused by immediate postpartum insertion of the LNG IUD.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2013)
Lactogenesis Stage 2 [ Time Frame: First 5 days after birth ]
To evaluate potential delay in lactogenesis caused by immediate postpartum insertion of the LNG IUD.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BLIS - Breastfeeding Levonorgestrel IUD Study
Official Title  ICMJE Randomized Controlled Trial of Early Versus Standard Postpartum Insertion of the Levonorgestrel IUD to Assess Breast Feeding Outcomes (BLIS - Breastfeeding Levonorgestrel IUD Study)
Brief Summary We are studying the effect of placing the levonorgestrel IUD (Mirena) immediately after birth on breastfeeding. Women who wish to have a levonorgestrel IUD placed after their birth, wish to breastfeed, and are willing to participate in the study will be randomly assigned to either get the IUD placed immediately after delivery of the baby and placenta or 4-6 weeks later. We do not believe there will be a difference in breastfeeding 8 weeks after delivery between those who get the IUD placed early or later.
Detailed Description

Increasing use of the levonorgestrel intrauterine device (LNG IUD) has become a cornerstone of U.S. efforts to decrease our nation's high rate of unplanned pregnancy. Many women initiate use of this method in the post partum period. The major advantage of immediate postplacental LNG IUD insertion is the prompt initiation of a highly effective contraceptive method at a time that does not interfere with the intense demands of newborn care, but any contraceptive method initiated in the postpartum period must not interfere with breastfeeding.

Our long-term goal is to understand the impact of hormonal contraceptives, initiated early in the postpartum period, on breastfeeding. The central hypothesis is that quality of breastfeeding is not negatively affected by progestin-only hormonal contraceptives.

We will pursue three specific aims comparing women randomized to immediate post-placental vs. delayed (4-6 week) postpartum LNG IUD insertion:

Aim #1: To determine breastfeeding continuation rates at 8 weeks in both groups Aim #2: To determine timing of lactogenesis in both groups Aim #3: To assess breastfeeding continuation, exclusivity, and satisfaction as well as continuation and satisfaction with the LNG IUD at 26 weeks postpartum in both groups

This proposal will support a non-inferiority RCT where participants will be randomly assigned to immediate postplacental insertion (within 10 minutes of placental delivery) or delayed postpartum insertion (4-6 weeks postpartum). This project will provide needed evidence on breastfeeding impact of early postpartum initiation of the LNG IUD.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Contraception
Intervention  ICMJE Drug: Levonorgestrel IUD
Timing of IUD insertion
Other Name: Mirena
Study Arms  ICMJE
  • Experimental: Early IUD Insertion Group
    Immediate post-placental placement of the levonorgestrel IUD
    Intervention: Drug: Levonorgestrel IUD
  • Active Comparator: Standard Postpartum Insertion Group
    Placement of the levonorgestrel IUD 4-6 weeks postpartum
    Intervention: Drug: Levonorgestrel IUD
Publications * Not Provided

*   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: May 16, 2017)
285
Original Estimated Enrollment  ICMJE
 (submitted: November 15, 2013)
317
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy, 18-40 year old pregnant women
  • Intend to breastfeed
  • Desire the LNG IUD as their method of contraception
  • Agree to be randomized to early versus standard postpartum insertion
  • Have delivered a healthy term infant (37 weeks gestation)
  • Willing to complete all study related procedures, visits and questionnaires

Exclusion Criteria:

  • Chorioamnionitis
  • Obstetric complications including transfusion
  • Severe pregnancy induced hypertension
  • Prolonged hospitalization
  • Coagulopathy
  • Liver disease
  • Undiagnosed genital bleeding, or other relative contraindication to LNG IUD insertion (known or suspected pregnancy, uterine cavity abnormality, known, suspected, or history of breast cancer, or hypersensitivity to any of the components in the LNG IUD).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT01990703
Other Study ID Numbers  ICMJE 62844
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David Turok, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE
  • Society of Family Planning
  • University of New Mexico
Investigators  ICMJE
Principal Investigator: David K Turok, MD University of Utah Department of Obstetrics & Gynecology
PRS Account University of Utah
Verification Date May 2017

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