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BLIS - Breastfeeding Levonorgestrel IUD Study (BLIS)

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

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.

Condition or disease Intervention/treatment Phase
Contraception Drug: Levonorgestrel IUD Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 285 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Early Versus Standard Postpartum Insertion of the Levonorgestrel IUD to Assess Breast Feeding Outcomes (BLIS - Breastfeeding Levonorgestrel IUD Study)
Study Start Date : January 2014
Primary Completion Date : November 2016
Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Early IUD Insertion Group
Immediate post-placental placement of the levonorgestrel IUD
Drug: Levonorgestrel IUD
Timing of IUD insertion
Other Name: Mirena
Active Comparator: Standard Postpartum Insertion Group
Placement of the levonorgestrel IUD 4-6 weeks postpartum
Drug: Levonorgestrel IUD
Timing of IUD insertion
Other Name: Mirena

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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).

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 identifier (NCT number): NCT01990703

United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Society of Family Planning
University of New Mexico
Principal Investigator: David K Turok, MD University of Utah Department of Obstetrics & Gynecology

Responsible Party: David Turok, M.D., University of Utah Identifier: NCT01990703     History of Changes
Other Study ID Numbers: 62844
First Posted: November 21, 2013    Key Record Dates
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by David Turok, University of Utah:
Birth Control
Levonorgestrel IUD
Mirena IUD

Additional relevant MeSH terms:
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral