反向注射器技术在哺乳期女性乳头内陷管理中的应用：一项先导随机对照试验。

The inverted syringe technique for management of inverted nipples in breastfeeding women: a pilot randomized controlled trial.

机构信息

Department of Pediatrics and Adolescent Medicine, Faculty of Medicine, American University of Beirut, Beirut, Lebanon.

Department of Obstetrics and Gynecology, Faculty of Medicine, American University of Beirut, Beirut, Lebanon.

出版信息

Int Breastfeed J. 2022 Feb 5;17(1):9. doi: 10.1186/s13006-022-00452-1.

DOI:10.1186/s13006-022-00452-1

PMID:35123525

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8817654/

Abstract

BACKGROUND

Women with inverted nipples may struggle with breastfeeding and may stop exclusive breastfeeding before six months. The use of an inverted syringe to evert the nipples was successful in achieving high rates of infant latching and exclusive breastfeeding in case series but has not been tested in clinical trials. This open label, parallel group, randomized clinical trial investigated whether the use of the inverted syringe technique in women with inverted nipples would increase exclusive breastfeeding rate at one month, as compared to standard care.

METHODS/DESIGN: Between June 2018 and January 2020, healthy pregnant women (N=54) with grades 1 or 2 inverted nipples were randomly allocated to standard care or to an experimental group that used the inverted syringe technique to evert the inverted nipple prior to every breastfeeding. The primary outcome measure was the rate of exclusive breastfeeding at one month. Secondary outcomes included the rates of exclusive breastfeeding at three and six months, any breastfeeding at one, three, and six months, nipple eversion, successful infant latching, breastfeeding-associated complications, maternal satisfaction with breastfeeding, maternal quality of life, and adverse events. Descriptive and bivariate analyses were conducted according to the intention to treat principle.

RESULTS

Participants in the experimental group were less likely to be exclusively breastfeeding at one (RR = 0.65, 95% CI: 0.44, 0.95; n = 47), and at three months (RR = 0.66, 95% CI: 0.47, 0.91; n = 45), or to practice any breastfeeding at six months (RR = 0.54, 95% CI: 0.34, 0.87; n = 44). Only 14.3% of women in the experimental group complied with the use of the inverted syringe during the first month. Breast pump and breastfeeding-associated complications were more commonly reported in the control group (p < 0.05 for both). Both groups had similar rates of nipple eversion, successful infant latching, and similar satisfaction with breastfeeding and quality of life issues.

CONCLUSION

The inverted syringe technique was not associated with improvement in breastfeeding outcomes of women with inverted nipples. Larger clinical trials are needed to confirm our findings.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03529630 ; Registered May 8, 2018.

摘要

背景

乳头内陷的女性在母乳喂养方面可能会遇到困难，并且可能在六个月前就停止了纯母乳喂养。在病例系列研究中，使用倒置注射器使乳头外翻的方法在婴儿含接和纯母乳喂养方面取得了很高的成功率，但尚未在临床试验中得到验证。本项开放标签、平行组、随机临床试验旨在调查在乳头内陷的女性中使用倒置注射器技术是否会比标准护理增加一个月时的纯母乳喂养率。

方法/设计：2018 年 6 月至 2020 年 1 月，将 54 名健康的初产妇（乳头内陷 1 级或 2 级）随机分配至标准护理组或实验组，实验组在每次母乳喂养前使用倒置注射器技术使乳头外翻。主要结局指标为一个月时的纯母乳喂养率。次要结局指标包括三个月和六个月时的纯母乳喂养率、一个月、三个月和六个月时的任何母乳喂养率、乳头外翻、婴儿成功含接、与母乳喂养相关的并发症、母亲对母乳喂养的满意度、母亲的生活质量以及不良事件。根据意向治疗原则进行描述性和双变量分析。

结果

实验组中一个月时（RR = 0.65，95%CI：0.44，0.95；n = 47）和三个月时（RR = 0.66，95%CI：0.47，0.91；n = 45）纯母乳喂养以及六个月时任何母乳喂养的比例均较低。实验组中只有 14.3%的女性在第一个月内遵守了使用倒置注射器的规定。对照组中更常报告使用吸奶器和与母乳喂养相关的并发症（p < 0.05）。两组的乳头外翻、婴儿成功含接的比例以及对母乳喂养和生活质量问题的满意度相似。