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BLIS - Breastfeeding Levonorgestrel IUD Study (BLIS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01990703
First Posted: November 21, 2013
Last Update Posted: June 14, 2017
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.
Collaborators:
Society of Family Planning
University of New Mexico
Information provided by (Responsible Party):
David Turok, University of Utah
  Purpose
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 Intervention Phase
Contraception Drug: Levonorgestrel IUD Phase 4

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by David Turok, University of Utah:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 285
Study Start Date: January 2014
Study Completion Date: January 2017
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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
Criteria

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).
  Contacts and Locations
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): NCT01990703


Locations
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
Investigators
Principal Investigator: David K Turok, MD University of Utah Department of Obstetrics & Gynecology
  More Information

Responsible Party: David Turok, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01990703     History of Changes
Other Study ID Numbers: 62844
First Submitted: November 15, 2013
First Posted: November 21, 2013
Results First Submitted: March 27, 2017
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:
Contraception
Birth Control
Levonorgestrel IUD
Mirena IUD

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