Clinical trial NCT03978598: Breastfeeding Etonogestrel Implant Study
Official title: Effect of Immediate Versus Standard Postpartum Insertion of the Contraceptive Implant on Breastfeeding Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2019-06-07
Enrollment: 150
Sex: FEMALE
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are studying the effect of placing the etonogestrel implant (Nexplanon) in the first 24 hours after birth on breastfeeding. Women who wish to have an etonogestrel implant placed after their birth, wish to breastfeed, and are willing to participate in the study will be randomly assigned to either get the implant placed in the first 24 hours after delivery of the baby and placenta or 4-6 weeks later. The investigators do not believe there will be a difference in breastfeeding 8 weeks after delivery or time to lactogenesis between those who get the implant placed early or later.

Detailed description: Counseling and provision of postpartum contraception is an integral component of comprehensive reproductive healthcare. A woman's preference for contraception is paramount; early initiation of postpartum contraception may assist in optimal birth spacing promoting the wellbeing of mother and baby. Equally important is the provision of appropriate support for breastfeeding. Exclusive breastfeeding for six months with continuation beyond one year of age is recommended by the American Academy of Pediatrics (AAP), American Academy of Family Physicians, American College of Obstetricians and Gynecologists (ACOG), and the World Health Organization (WHO).

The utilization of Long Acting Reversible Contraception (LARC's) has increased in the last decade. The etonogestrel (ENG) implant is one of the most effective LARC's and has become one of the methods used by many women in the postpartum period to prevent an unplanned pregnancy. The major advantage of immediate ENG implant insertion is the prompt initiation of a highly effective contraceptive method at a time that does not interfere with breastfeeding and the life changes and demands of motherhood.

Our long-term goal is to understand the impact of the ENG implant hormonal contraceptive, initiated early in the postpartum period, on breastfeeding. The central hypothesis is that breastfeeding continuation at eight weeks postpartum is not inferior in women in the immediate insertion group of the ENG implant than in those with standard insertion and that time to lactogenesis stage II is not more than 8 hours difference between the immediate insertion and standard insertion groups.

Primary:

Aim #1: To determine breastfeeding continuation rates at 8 weeks in both groups.

Aim #2: To determine the timing of lactogenesis in both groups

Secondary:

Aim #1: To assess breastfeeding continuation and exclusivity between the immediate versus the standard group. Aim #2: To compare postpartum factors associated with discontinuing breastfeeding between the immediate versus the standard group. Aim #3: To compare participant satisfaction with postpartum contraception counseling in women enrolled in the study and in those women who opted not to enroll in the study between the immediate versus the standard group. Aim #4: To compare postpartum mood as measured by EPDS score between the immediate versus the standard group. Aim #5: To compare postpartum sexual function as measured by Female Sexual Function Index (FSFI) score between the immediate versus the standard group. Aim #6: To compare the total number of days of postpartum bleeding in the immediate versus standard. Aim #7: To compare participant satisfaction with the timing of ENG implant insertion between the immediate versus the standard group

This proposal will support a non-inferiority RCT where participants will be randomly assigned to immediate insertion (first 24 hours after delivery) or delayed postpartum insertion (4-6 weeks postpartum). This project will provide needed evidence on breastfeeding impact of early postpartum initiation of the ENG implant.

Eligibility criteria: Inclusion Criteria:

* Pregnant women or women who have delivered vaginally and by cesarean section within 22 hours (2-hour window will allow for implant insertion by 24 hours postpartum)
* Aged 13 and older
* English or Spanish speakers
* Deliver an infant at UNM Hospital at \> 37 weeks gestational age
* Intend to breastfeed
* Desire the implant as a method for contraception
* Agree to randomization
* Must have a working phone (study questions to be answered through phone calls or accessed electronically by a link sent through email or text message)

Exclusion Criteria:

* Under age 13
* History of breast cancer (screen by past medical history)
* History of undiagnosed vaginal bleeding (screen by past medical history)
* Head trauma that affected pituitary function (screen by past medical history)
* Prolactin insufficiency (screen by past medical history)
* Previous lactation failure (defined as no lactation within 5 days postpartum)
* Any contraindication to lactation/implant use including diseases transmittable by breast milk (screen by past medical history)
* Liver dysfunction (screen by past medical history)
* Use of drugs that inhibit lactation (screen by medical history)
* Sensitivity to the components of the ENG implant (screen by past medical history)
* Contraindications to use the implant by the (US MEC) (screen by past medical history)
* Active labor
* Delivery at \< 37 weeks gestational age

Primary outcomes:
measure: Continuation of breastfeeding.
timeFrame: For the primary outcome will be the first eight weeks after delivery.
measure: Time to lactogenesis.
timeFrame: First 7 days.
Secondary outcomes:
measure: Exclusive breastfeeding.
timeFrame: Up to 24 weeks postpartum.
measure: Factors associated with breastfeeding discontinuation.
timeFrame: Up to 24 weeks postpartum.
measure: Satisfaction with postpartum contraception counseling
timeFrame: Up to 24 weeks postpartum.
measure: Postpartum mood.
timeFrame: Up to 24 weeks postpartum.
measure: Sexual Function.
timeFrame: Up to 24 weeks postpartum.
measure: Postpartum bleeding days.
timeFrame: Up to 24 weeks postpartum.
measure: Satisfaction with timing of implant insertion: questionnaire
timeFrame: Up to 24 weeks postpartum.
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
state: Utah
Study officials:
affiliation: University of New Mexico
name: Jamie Krashin@salud.unm.edu
role: PRINCIPAL_INVESTIGATOR
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