Clinical trial NCT04258709: PRenatal Video-Based Education and PostPARtum Effects
Official title: Effect of Antenatal Milk Expression on Breastfeeding Outcomes Among Overweight and Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: antenatal milk expression
antenatal colostrum
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-02-06
Enrollment: 280
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: The purpose of the PREPARE Trial is to examine the impact of an antenatal milk expression (AME) intervention among women with pre-pregnancy BMI 25 or more on breastfeeding outcomes, including breastfeeding self-efficacy, breastfeeding duration and exclusivity, and perception of insufficient milk supply. Specifically, the investigators will:

1. Determine the effect of the AME intervention on short-term breastfeeding outcomes, including breastfeeding self-efficacy and exclusivity, to two weeks postpartum.
2. Explore the sustained effect of the AME intervention on longer-term breastfeeding duration and exclusivity over the first year postpartum.
3. Examine participants' experiences with and perceptions of AME.

Eligibility criteria: Inclusion Criteria:

* Pregnant women who:

  1. have a pre-pregnancy BMI ≥ 25
  2. are ≥ 18 years
  3. are English-speaking
  4. are 34 0/7-36 6/7 gestational weeks
  5. are nulliparous
  6. intend to/have interest in breastfeeding after birth
  7. are having a singleton pregnancy
  8. plan to receive prenatal care and deliver at select hospital/birth facility systems (access to EMR data)

Exclusion Criteria:

1. contraindications to breastfeeding as specified by the American Academy of Pediatrics
2. history of breast reduction surgery or radiation
3. indication for delivery by 37 weeks gestation
4. gestational or pre-existing diabetes

Primary outcomes:
measure: Breastfeeding Exclusivity
timeFrame: 2 weeks postpartum
measure: Breastfeeding Self-efficacy
timeFrame: 2 weeks postpartum
Secondary outcomes:
measure: Number of Participants Exclusively Breastfeeding During Postpartum Hospitalization
timeFrame: Postpartum hospitalization (0-4 days postpartum)
measure: Number of Participants Exclusively Breastfeeding at 2 Weeks Postpartum
timeFrame: 2 weeks postpartum
measure: Number of Participants Exclusively Breastfeeding at 6 Weeks Postpartum
timeFrame: 6 weeks postpartum
measure: Number of Participants Exclusively Breastfeeding at 12 Weeks Postpartum
timeFrame: 12 weeks postpartum
measure: Number of Participants Exclusively Breastfeeding at 6 Months Postpartum
timeFrame: 6 months postpartum
measure: Breastfeeding Exclusivity (Categorical)
timeFrame: 0-4 days postpartum
measure: Breastfeeding Exclusivity (Categorical)
timeFrame: 2 weeks
measure: Breastfeeding Exclusivity (Categorical)
timeFrame: 6 weeks postpartum
measure: Breastfeeding Exclusivity (Categorical)
timeFrame: 12 weeks postpartum
measure: Breastfeeding Exclusivity (Categorical)
timeFrame: 6 months postpartum
measure: Breastfeeding Self-efficacy
timeFrame: 6 weeks postpartrum
measure: Breastfeeding Self-efficacy
timeFrame: 12 weeks postpartum
measure: Number of Participants Breastfeeding at Postpartum Hospitalization (0-4 Days Postpartum)
timeFrame: Postpartum hospitalization (0-4 days postpartum)
measure: Number of Participants Breastfeeding at 2 Weeks Postpartum
timeFrame: 2 weeks postpartum
measure: Number of Participants Breastfeeding at 6 Weeks Postpartum
timeFrame: 6 weeks postpartum
measure: Number of Participants Breastfeeding at 12 Weeks Postpartum
timeFrame: 12 weeks postpartum
measure: Number of Participants Breastfeeding at 6 Months Postpartum
timeFrame: 6 months postpartum
measure: Number of Participants Breastfeeding at 12 Months Postpartum
timeFrame: 12 months postpartum
measure: Onset of Lactogenesis II
timeFrame: 2 weeks postpartum
measure: Perceived Milk Supply (Continuous)
timeFrame: 2 weeks postpartum
measure: Perceived Milk Supply (Continuous)
timeFrame: 6 weeks postpartum
measure: Perceived Milk Supply (Continuous)
timeFrame: 12 weeks postpartum
measure: Perceived Milk Supply (Dichotomous)
timeFrame: 2 weeks postpartum
measure: Perceived Milk Supply (Dichotomous)
timeFrame: 6 weeks postpartum
measure: Perceived Milk Supply (Dichotomous)
timeFrame: 12 weeks postpartum
measure: Number of Participants Commenting on the Impact/Integration of AME During Pregnancy and Utilization of Antenatally Collected Milk During the Postpartum Period
timeFrame: 6 weeks postpartum
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jill Demirci, PhD
role: PRINCIPAL_INVESTIGATOR
References: