NCT04258709Completed
PRenatal Video-Based Education and PostPARtum Effects
Effect of Antenatal Milk Expression on Breastfeeding Outcomes Among Overweight and Obese Women
Source: ClinicalTrials.gov · Last updated 19 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 280 (actual)
- First submitted
- 3 Feb 2020
- Start date
- 23 Sept 2020
- Primary completion date
- 13 Dec 2023
- Lead sponsor
- University of Pittsburgh
- Diseases
- Obesity
- NCT number
- NCT04258709
What you commit to
- Study type: Interventional
- Participants enrolled: 280
- From 23 Sept 2020 to the primary completion date, 13 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- history of breast reduction surgery or radiation
- gestational or pre-existing diabetes
Other
- contraindications to breastfeeding as specified by the American Academy of Pediatrics
- indication for delivery by 37 weeks gestation
Who the study is looking for
- 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)
Age in the registry: 18 years to 45 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.