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N/A N=280 Randomized Triple-blind Supportive Care

PRenatal Video-Based Education and PostPARtum Effects

Breastfeeding

Enrolled (actual)
280
Serious AEs
49.3%
Results posted
Mar 2025
Primary outcome: Primary: Breastfeeding Exclusivity — 67; 84 Participants — p=.1200

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
AME (Behavioral); Video-based infant care education (Behavioral)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
University of Pittsburgh
Primary completion
Dec 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Breastfeeding Exclusivity
67; 84 .1200
PRIMARY
Breastfeeding Self-efficacy
52.6; 49.7 .3861
SECONDARY
Number of Participants Exclusively Breastfeeding During Postpartum Hospitalization
79; 76; 59; 61 .8614
SECONDARY
Number of Participants Exclusively Breastfeeding at 2 Weeks Postpartum
45; 46; 76; 81 .9788
SECONDARY
Number of Participants Exclusively Breastfeeding at 6 Weeks Postpartum
64; 73; 59; 49 .2173
SECONDARY
Number of Participants Exclusively Breastfeeding at 12 Weeks Postpartum
67; 69; 37; 42 .5209
SECONDARY
Number of Participants Exclusively Breastfeeding at 6 Months Postpartum
0; 2; 94; 99
SECONDARY
Breastfeeding Exclusivity (Categorical)
13; 11; 23; 28; 38; 40 .9071
SECONDARY
Breastfeeding Exclusivity (Categorical)
13; 11; 23; 28; 38; 40 .9071
SECONDARY
Breastfeeding Exclusivity (Categorical)
13; 11; 23; 28; 38; 40 .9071
SECONDARY
Breastfeeding Exclusivity (Categorical)
13; 11; 23; 28; 38; 40 .9071
SECONDARY
Breastfeeding Exclusivity (Categorical)
13; 11; 23; 28; 38; 40 .9071
SECONDARY
Breastfeeding Self-efficacy
52.6; 49.7 .3861
SECONDARY
Breastfeeding Self-efficacy
52.6; 49.7 .3861
SECONDARY
Number of Participants Breastfeeding at Postpartum Hospitalization (0-4 Days Postpartum)
138; 136; 0; 2 .4779
SECONDARY
Number of Participants Breastfeeding at 2 Weeks Postpartum
121; 127; 10; 10 1
SECONDARY
Number of Participants Breastfeeding at 6 Weeks Postpartum
108; 107; 15; 15 .8031
SECONDARY
Number of Participants Breastfeeding at 12 Weeks Postpartum
96; 103; 8; 8 .8175
SECONDARY
Number of Participants Breastfeeding at 6 Months Postpartum
81; 90; 13; 11 .434
SECONDARY
Number of Participants Breastfeeding at 12 Months Postpartum
50; 51; 33; 40 .4968
SECONDARY
Onset of Lactogenesis II
5; 5; 16; 15; 40; 38 .9005
SECONDARY
Perceived Milk Supply (Continuous)
26.7; 29.6 .6299
SECONDARY
Perceived Milk Supply (Continuous)
26.7; 29.6 .6299
SECONDARY
Perceived Milk Supply (Continuous)
26.7; 29.6 .6299
SECONDARY
Perceived Milk Supply (Dichotomous)
22; 22; 74; 81 .8499
SECONDARY
Perceived Milk Supply (Dichotomous)
22; 22; 74; 81 .8499
SECONDARY
Perceived Milk Supply (Dichotomous)
22; 22; 74; 81 .8499
SECONDARY
Number of Participants Commenting on the Impact/Integration of AME During Pregnancy and Utilization of Antenatally Collected Milk During the Postpartum Period
11; 15; 26; 0; 11; 0

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.

Eligibility Criteria

Inclusion Criteria

  • Pregnant women who:
  • have a pre-pregnancy BMI ≥ 25
  • are ≥ 18 years
  • are English-speaking
  • are 34 0/7-36 6/7 gestational weeks
  • are nulliparous
  • intend to/have interest in breastfeeding after birth
  • are having a singleton pregnancy
  • plan to receive prenatal care and deliver at select hospital/birth facility systems (access to EMR data)

Exclusion Criteria

  • contraindications to breastfeeding as specified by the American Academy of Pediatrics
  • history of breast reduction surgery or radiation
  • indication for delivery by 37 weeks gestation
  • gestational or pre-existing diabetes
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04258709). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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