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Early versus delayed postpartum insertion of the levonorgestrel IUD and impact on breastfeeding: A randomized controlled non-inferiority trial

David Turok, University of Utah, 2013

Project abstract

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). The primary outcome will assess a total of 264 participants for breastfeeding continuation at 8 weeks postpartum. Secondary outcome measures include time to lactogenesis, duration of exclusive or any breastfeeding, return to sexual activity, milk content, milk levonorgestrel levels and infant growth parameters.

This innovative project will provide needed evidence on breastfeeding impact of early postpartum initiation of the LNG IUD and will be the first step in establishing a prospective meta-analysis assessing the role of progestin containing contraceptives on breastfeeding outcomes.

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