Clinical trial NCT01990703: BLIS - Breastfeeding Levonorgestrel IUD Study
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Keywords: Contraception
Birth Control
Levonorgestrel IUD
Mirena IUD
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
name: University of New Mexico
First posted: 2013-11-21
Enrollment: 285
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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).

Primary outcomes:
measure: Breastfeeding Continuation Rates at 8 Weeks Postpartum
timeFrame: 8 weeks postpartum
Secondary outcomes:
measure: Time to Lactogenesis Stage 2
timeFrame: First 5 days after birth
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
Study officials:
affiliation: University of Utah Department of Obstetrics & Gynecology
name: David K Turok, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hopelian NG, Simmons RG, Sanders JN, Ward K, Jenkins SM, Espey E, Turok DK. Comparison of levonorgestrel level and creamatocrit in milk following immediate versus delayed postpartum placement of the levonorgestrel IUD. BMC Womens Health. 2021 Jan 21;21(1):33. doi: 10.1186/s12905-021-01179-7.