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

Authors
  • Sakalidis, Vanessa S1
  • Ivarsson, Lennart1
  • Haynes, Alan G2
  • Jäger, Linda1
  • Schärer-Hernández, Nania G1
  • Mitoulas, Leon R1
  • Prime, Danielle K1
  • 1 Medela AG, Baar, Switzerland. , (Switzerland)
  • 2 Clinical Trials Unit (CTU) Bern, Faculty of Medicine, University of Bern, Bern, Switzerland. , (Switzerland)
Type
Published Article
Journal
Acta Obstetricia Et Gynecologica Scandinavica
Publisher
Wiley (Blackwell Publishing)
Publication Date
Nov 01, 2020
Volume
99
Issue
11
Pages
1561–1567
Identifiers
DOI: 10.1111/aogs.13897
PMID: 32401335
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

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. 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. 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. 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. © 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).

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