PRenatal Video-Based Education and PostPARtum Effects

NCT04258709 | Completed Results

• 2 other identifiers: STUDY19030116R01HD098186
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding

Keywords

antenatal milk expression; antenatal colostrum

Outcome Measures

Primary Outcomes (2)

• Breastfeeding Exclusivity

  Whether participant is feeding 100% breast milk at 2 weeks postpartum

  2 weeks postpartum

• Breastfeeding Self-efficacy

  Score on Breastfeeding Self-Efficacy Scale-SF (score range 14-70, with higher score represents better outcome)

  2 weeks postpartum

Secondary Outcomes (26)

• Number of Participants Exclusively Breastfeeding During Postpartum Hospitalization

  Postpartum hospitalization (0-4 days postpartum)

• Number of Participants Exclusively Breastfeeding at 2 Weeks Postpartum

  2 weeks postpartum

• Number of Participants Exclusively Breastfeeding at 6 Weeks Postpartum

  6 weeks postpartum

• Number of Participants Exclusively Breastfeeding at 12 Weeks Postpartum

  12 weeks postpartum

• Number of Participants Exclusively Breastfeeding at 6 Months Postpartum

  6 months postpartum

Study Arms (2)

Antenatal Milk Expression (AME) Intervention Group

EXPERIMENTAL

Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.

Behavioral: AME

Video-based Infant Care Education Control Group

ACTIVE COMPARATOR

Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).

Behavioral: Video-based infant care education

Interventions

AME BEHAVIORAL

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

Antenatal Milk Expression (AME) Intervention Group

Video-based infant care education BEHAVIORAL

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

Video-based Infant Care Education Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Demirci JR, Glasser M, Bogen DL, Sereika SM, Ren D, Ray K, Bodnar LM, O'Sullivan TA, Himes K. Effect of antenatal milk expression education on lactation outcomes in birthing people with pre-pregnancy body mass index >/=25: protocol for a randomized, controlled trial. Int Breastfeed J. 2023 Mar 16;18(1):16. doi: 10.1186/s13006-023-00552-6.

  PMID: 36927811 DERIVED

MeSH Terms

Conditions

Breast Feeding

Interventions

methylamphotericin B

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Results Point of Contact

• Title: Dr. Jill Demirci
• Organization: University of Pittsburgh

JVR5@pitt.edu

412-648-9236

Study Officials

• Jill Demirci, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Statistician completing final analysis of data will be blinded to group assignment. An unbiased, third party will conduct qualitative interviews. Participants, obstetric providers in recruitment clinics, and lactation consultant interventionists will be blinded to outcomes of interest.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 6, 2020
• Study Start: September 23, 2020
• Primary Completion: December 13, 2023
• Study Completion: November 29, 2024
• Last Updated: March 19, 2025
• Results First Posted: March 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At the conclusion of the study, after publication of main findings.
• Access Criteria: Contact study investigator or NICHD for access to data repository.

Locations

US (1)