Breast shield design impacts milk removal dynamics during pumping: A randomized controlled non-inferiority trial

Vanessa S Sakalidis, Lennart Ivarsson, Alan G Haynes, Linda Jäger, Nania G Schärer-Hernández, Leon R Mitoulas, Danielle K Prime, Vanessa S Sakalidis, Lennart Ivarsson, Alan G Haynes, Linda Jäger, Nania G Schärer-Hernández, Leon R Mitoulas, Danielle K Prime

Abstract

Introduction: While many studies have investigated the importance of optimizing pumping patterns for milk removal, the influence of breast shield design on milk removal has not been the focus of extensive investigation. This study aimed to determine the effectiveness of breast shields with either a 105° or a 90° flange opening angle on breast drainage and milk volume expressed during pumping.

Material and methods: This study was a cross-over, randomized controlled non-inferiority trial (Registration; NCT03091985). Mothers (n = 49) of breastfeeding infants participated in the study over two study sessions. Participants were randomly assigned to pump both breasts simultaneously for 15 minutes with either the 105° or 90° breast shield in the first session, and the other shield in the second session. Effectiveness (breast drainage) and efficiency (volume expressed) of both breast shields were assessed after 15 minutes of pumping. Intention-to-treat and per protocol analyses were performed to determine if the 105° breast shield was non-inferior to the 90° breast shield for breast drainage and volume expressed. Perceived comfort was assessed via questionnaire.

Results: The 105° breast shield was both non-inferior and superior compared to the standard 90° shield for breast drainage (intention-to-treat, 3.87% (0.01-7.72), P = .049) and volume expressed (intention-to-treat, 9.14 mL (1.37-16.91), P=.02). In addition, the 105° shield was rated as feeling more comfortable (P < .001) and as having an improved fit to the breast (P < .001) compared to the 90° shield.

Conclusions: Expressing with the 105° breast shield was more efficient, effective and comfortable compared to the 90° shield. Breast shield design can significantly impact pumping outcomes, and an opening angle of 105° improves both the dynamics and comfort of milk removal.

Keywords: breast expression; breast pumping; breastfeeding; infant; lactation.

Conflict of interest statement

This clinical study was conducted and financed by Medela AG, Switzerland. LJ, NGSH, LRM, and DKP are employees of Medela AG. VSS and LI were employees of Medela AG during the planning, data collection and manuscript preparation phases of the study. AGH is an employee of CTU Bern, The University of Bern, Switzerland. CTU Bern, University of Bern staff policy prohibits its employees from the direct acceptance of honoraria or consultancy fees.

© 2020 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).

Figures

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Consort Flowchart

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