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Lanolin for the treatment of nipple pain in breastfeeding women: a randomized controlled trial.

ABSTRACT: Nipple pain and damage are commonly experienced by breastfeeding women and are associated with negative breastfeeding outcomes. Health care providers often recommend the application of lanolin to treat painful/damaged nipples, yet no randomized controlled trial has evaluated the effectiveness of lanolin on nipple pain and breastfeeding outcomes. The purpose of this study was to evaluate the effect of lanolin on nipple pain among breastfeeding women with damaged nipples. A randomized, single-blind, controlled trial was conducted at a tertiary care hospital in Hamilton, Ontario, Canada. Breastfeeding women (N?=?186) identified as having nipple pain/damage were randomized to apply lanolin (intervention group; n?=?93) or to receive usual postpartum care (control group; n?=?93). The primary outcome was nipple pain at 4 days post-randomization measured by the Numeric Rating Scale. Additional outcomes included nipple pain measured by the Short Form McGill Pain Questionnaire, breastfeeding duration/exclusivity, breastfeeding self-efficacy, and maternal satisfaction with lanolin treatment versus usual care. The results revealed no significant group differences in mean pain scores at 4 days post-randomization. Women in both groups experienced clinically relevant decreases in nipple pain by 7 days post-randomization. Significantly, more women in the lanolin group reported that they were satisfied with treatment compared with those receiving usual care. No significant group differences were found for other secondary outcomes. While more women were satisfied using lanolin, its application to sore/damaged nipples was ineffective for reducing nipple pain or improving breastfeeding outcomes.

SUBMITTER: Jackson KT

PROVIDER: S-EPMC6865977 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Lanolin for the treatment of nipple pain in breastfeeding women: a randomized controlled trial.

Jackson Kimberley T KT Dennis Cindy-Lee CL

Maternal & child nutrition 20160801 3

Nipple pain and damage are commonly experienced by breastfeeding women and are associated with negative breastfeeding outcomes. Health care providers often recommend the application of lanolin to treat painful/damaged nipples, yet no randomized controlled trial has evaluated the effectiveness of lanolin on nipple pain and breastfeeding outcomes. The purpose of this study was to evaluate the effect of lanolin on nipple pain among breastfeeding women with damaged nipples. A randomized, single-blin ...[more]

PMID: 27477840

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Project description:INTRODUCTION:Nipple fissure and nipple pain are common complaints among breastfeeding mothers. Studies found that mupirocin was effective in preventing and treating infections of damaged nipple and nipple pain. Acidic fibroblast growth factor (aFGF) plays an important role in wound healing. However, current evidence on the efficacy and safety of mupirocin plus aFGF for nipple fissure and nipple pain in breastfeeding women is inconclusive due to the lack of well-designed randomised controlled trials on this topic. The purpose of this study is to test the hypothesis that mupirocin plus aFGF is more effective than mupirocin alone for nipple fissure and nipple pain in breastfeeding women. METHODS AND ANALYSIS:This study is a randomised, double-blind, single-centre, parallel-group clinical trial. A total of 120 breastfeeding women with nipple fissure and nipple pain will be randomly assigned to either mupirocin plus aFGF group or mupirocin plus placebo group according to a computer-generated random allocation sequence. The treatment period lasts 14 days. The primary outcome is nipple pain intensity measured by the Visual Analogue Scale on day 14 during the treatment period. Secondary outcome measures include time to complete nipple pain relief, changes in the Nipple Trauma Score, time to complete healing of nipple trauma, quality of life measured by the Maternal Postpartum Quality of Life (MAPP-QOL) Questionnaire, the frequency of breast feeding, the rate of breastfeeding discontinuation, weight change in infants and adverse events. ETHICS AND DISSEMINATION:The study has gained approval from the Ethics Review Committee of Tianjin Central Hospital of Gynaecology Obstetrics on 22 January 2018 (approval no. 2018KY001). We plan to publish our research findings in a peer-reviewed academic journal and disseminate these findings in international conferences. This study has been registered with the Chinese Clinical Trial Registry. TRIAL REGISTRATION NUMBER:ChiCTR1800017248.

Project description:BackgroundWomen 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/designBetween 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.ResultsParticipants 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.ConclusionThe 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 registrationClinicalTrials.gov NCT03529630 ; Registered May 8, 2018.

Dataset Information

Lanolin for the treatment of nipple pain in breastfeeding women: a randomized controlled trial.

Publications

Lanolin for the treatment of nipple pain in breastfeeding women: a randomized controlled trial.

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