Antenatal Milk Expression Education for Breastfeeding
(PREPARE Trial)
Trial Summary
What is the purpose of this trial?
The purpose of this randomized controlled trial is to examine the impact of a remotely-delivered antenatal milk expression (AME) intervention versus an attention control condition on breastfeeding outcomes among a sample of 280 nulliparous, non-diabetic women with pre-pregnancy body mass indices ≥ 25. AME involves milk expression and collection in the third pregnancy trimester and is theorized to address multiple barriers to breastfeeding among women with higher BMI, including impaired breastfeeding self-efficacy, insufficient milk supply (critical period endocrine modulation of milk volume), and early formula supplementation in the context of a medically complex birth (availability of banked antenatal milk). Participants will be enrolled in their third trimester of pregnancy and allocated into one of two study arms: 1) AME instruction delivered by remote, live International Board Certified Lactation Consultants via an innovative app-based telelactation platform; or 2) an attention control condition (video-based infant care education unrelated to infant feeding). Video-based education for both groups will occur in weekly study visits from 37 to 40 weeks gestation, with women in the intervention group continuing AME 1-2 times per day at home. Measured outcomes of interest will include short and long-term breastfeeding practices (e.g., breastfeeding duration, exclusivity) and participants' experiences with and perceptions of AME.
Research Team
Jill Demirci, PhD
Principal Investigator
University of Pittsburgh
Eligibility Criteria
This trial is for first-time pregnant women with a BMI ≥ 25, interested in breastfeeding, between 34-36 weeks of pregnancy. They must plan to give birth at certain hospitals and speak English. Women with plans for early delivery, breast surgery history, or diabetes are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Antenatal Milk Expression (AME) Intervention
Weekly video interactions with lactation consultants to teach and reinforce antenatal milk expression, with at-home practice of hand expression and collection of expressed milk
Postpartum Follow-up
Participants are monitored for breastfeeding outcomes, including self-efficacy, exclusivity, and duration
Treatment Details
Interventions
- AME
- Video-based infant care education
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator