CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 280 enrolled
Drug / intervention
AME +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04258709
NCT04258709N/ACompleted

Effect of Antenatal Milk Expression on Breastfeeding Outcomes Among Overweight and Obese Women

University of Pittsburgh·interventional·Posted Feb 6, 2020·Updated Mar 19, 2025

In Brief

A clinical study evaluating AME and Video-based infant care education for Breastfeeding. Completed, enrolled 280 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreastfeeding
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 6, 2020
Enrollment StartSep 23, 2020
Primary CompletionDec 13, 2023
Study CompletionNov 29, 2024
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 6.4 years ago

Interventions

AMEbehavioral

Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.

Video-based infant care educationbehavioral

Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.