BLIS - Breastfeeding Levonorgestrel IUD Study

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.

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).