BLIS - Breastfeeding Levonorgestrel IUD Study

Contraception Clinical Trial

— BLIS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01990703
• Other study ID #: 62844
• Status: Completed
• Phase: Phase 4
• First received: November 15, 2013
• Last updated: February 2, 2017
• Start date: January 2014
• Est. completion date: January 2017

Study information

• Verified date: August 2016
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Levonorgestrel IUD
Timing of IUD insertion

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	University of Utah Health Sciences Center	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
University of Utah	Society of Family Planning, University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breastfeeding continuation rates at 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.	8 weeks postpartum
Secondary	Lactogenesis Stage 2	To evaluate potential delay in lactogenesis caused by immediate postpartum insertion of the LNG IUD.	First 5 days after birth