Medela AG, Baar, Switzerland.
Clinical Trials Unit (CTU) Bern, Faculty of Medicine, University of Bern, Bern, Switzerland.
Acta Obstet Gynecol Scand. 2020 Nov;99(11):1561-1567. doi: 10.1111/aogs.13897. Epub 2020 Jun 5.
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.
尽管许多研究已经探讨了优化吸乳模式以促进乳汁排出的重要性，但乳房护罩设计对乳汁排出的影响尚未成为广泛研究的焦点。本研究旨在确定具有 105°或 90°法兰开口角度的乳房护罩在吸乳过程中的乳房排空效果和吸乳量。
这是一项交叉、随机对照非劣效性试验（注册号：NCT03091985）。母乳喂养婴儿的母亲（n=49）参加了这项研究，共进行了两次研究。参与者在第一次研究中随机被分配在 15 分钟内同时使用 105°或 90°的乳房护罩来同时吸双侧乳房，第二次研究则使用另一种护罩。在吸乳 15 分钟后，评估两种乳房护罩的有效性（乳房排空）和效率（表达的体积）。进行意向治疗和方案分析，以确定 105°乳房护罩在乳房排空和表达量方面是否不劣于标准 90°乳房护罩。通过问卷调查评估感知舒适度。
与标准 90°护罩相比，105°护罩在乳房排空（意向治疗，3.87%（0.01-7.72），P=.049）和表达量（意向治疗，9.14 mL（1.37-16.91），P=.02）方面均具有非劣效性和优越性。此外，与 90°护罩相比，105°护罩的舒适度评分更高（P<.001），并且更贴合乳房（P<.001）。
与 90°护罩相比，使用 105°护罩在效率、效果和舒适度方面都更优。乳房护罩设计会显著影响吸乳效果，而 105°的开口角度可以改善吸乳的动态和舒适度。
