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Study Protocol for a Stepped-Wedge Cluster (Nested) Randomized Controlled Trial of Antenatal Colostrum Expression (ACE) Instruction in First-Time Mothers: The ACE Study

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posted on 2024-02-06, 05:29 authored by Cassandra Cuffe, Roslyn Giglia, Matthew N Cooper, Julie Hill, Desiree Silva, Anita MoorheadAnita Moorhead, Valerie Verhasselt, Joshua R Lewis, Deborah Ireson, Jill R Demirci, Talea Cotte, Kathryn Webb, Frances Patey, Therese A O’Sullivan
Background: Although many mothers initiate breastfeeding, supplementation with human-milk substitutes (formula) during the birth hospitalization is common and has been associated with early breastfeeding cessation. Colostrum hand expressed in the last few weeks before birth, known as antenatal colostrum expression (ACE), can be used instead of human-milk substitutes. However, evidence is lacking on the efficacy of ACE on breastfeeding outcomes and in non-diabetic mothers. Methods and Planned Analysis: This multicenter stepped-wedge cluster (nested) randomized controlled trial aims to recruit 945 nulliparous pregnant individuals. The trial is conducted in two phases. During Phase 1, control group participants are under standard care. During Phase 2, participants are randomized to ACE instruction via a pre-recorded online video or a one-on-one session with a midwife. Adjusted logistic regression analysis will be used to examine the relationship between ACE instruction and breastfeeding outcomes. Research Aims and Questions: Primary aim: (1) Does advising pregnant individuals to practice ACE and providing instruction improve exclusive breastfeeding rates at 4 months postpartum? Secondary research questions: (2) Do individuals who practice ACE have higher rates of exclusive breastfeeding during the initial hospital stay after birth? (3) Is teaching ACE via an online video non-inferior to one-on-one instruction from a midwife? (4) Does expressing colostrum in pregnancy influence time to secretory activation, or (5) result in any differences in the composition of postnatal colostrum? Discussion: Trial findings have important implications for maternity practice, with the online video providing an easily accessible opportunity for ACE education as part of standard antenatal care.

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication ofthis article: The ACE Study is supported by the Western Australian Department of Health and the Stan Perron Charitable Foundation. The funding sources had no role in trial design and will have no role in the analyses and interpretation of the data or the decision to submit findings. TAO is the recipient of School of Medical and Health Sciences Seed Grant funding from Edith Cowan University (ECU) provided for colostrum analysis. The first author is the recipient of a Research Excellence Scholarship awarded by ECU. The salary ofJRL is supported by a National Heart Foundation Futur Leader Fellowship (ID : 102817). VV is funded by the Larsson-Rosenquist Foundation. The funders had no role in the study design, data collection, analysis, interpretation of the findings or writing the manuscript. No external funding was obtained for this trial protocol. The ORIGINS Project has received core funding support from the Telethon Perth Children's Hospital Research Fund, Joondalup Health Campus, the Paul Ramsay Foundation, and the Commonwealth Government of Australia through the Channel 7 Telethon Trust. Substantial in-kind support has been provided by Telethon Kids Institute and Joondalup Health Campus.

History

Publication Date

2024-02-01

Journal

Journal of Human Lactation

Volume

40

Issue

1

Article Number

08903344231215074

Pagination

16p. (p. 80-95)

Publisher

SAGE

ISSN

0890-3344

Rights Statement

© The Author(s) 2023. This article is distributed under the terms of the Creative Commons Attribution 4.0 License (https://creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).