N/A
N=280
PRenatal Video-Based Education and PostPARtum Effects
Breastfeeding
Bottom Line
View on ClinicalTrials.gov: NCT04258709 ↗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
| Outcome | Result | p-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
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.