BLIS - Breastfeeding Levonorgestrel IUD Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Utah
Sponsor:
Collaborators:
Society of Family Planning
University of New Mexico
Information provided by (Responsible Party):
David Turok, University of Utah
ClinicalTrials.gov Identifier:
NCT01990703
First received: November 15, 2013
Last updated: July 23, 2014
Last verified: July 2014
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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 University of Utah:

Primary Outcome Measures:
  • Breastfeeding continuation rates at 8 weeks postpartum [ Time Frame: 8 weeks postpartum ] [ Designated as safety issue: Yes ]
    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:
  • Lactogenesis Stage 2 [ Time Frame: First 5 days after birth ] [ Designated as safety issue: Yes ]
    To evaluate potential delay in lactogenesis caused by immediate postpartum insertion of the LNG IUD.


Estimated Enrollment: 317
Study Start Date: January 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
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: NCT01990703

Contacts
Contact: Maria Masters 801-213-2286 maria.masters@hsc.utah.edu

Locations
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Anne Fullilove    505-272-6391    AMFullilove@salud.unm.edu   
Principal Investigator: Eve Espey, MD         
United States, Utah
University of Utah Health Sciences Center Recruiting
Salt Lake City, Utah, United States, 84132
Contact: David K Turok, MD       david.turok@hsc.utah.edu   
Principal Investigator: David K Turok, MD         
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

No publications provided

Responsible Party: David Turok, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01990703     History of Changes
Other Study ID Numbers: 62844
Study First Received: November 15, 2013
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on July 28, 2014