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A combination of mupirocin and acidic fibroblast growth factor for nipple fissure and nipple pain in breastfeeding women: protocol for a randomised, double-blind, controlled trial.
BMJ Open 2019; 9(3):e025526BO

Abstract

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.

Authors+Show Affiliations

Galactophore Department, Tianjin Central Hospital of Gynecology Obstetrics, Tianjin, China.Galactophore Department, Tianjin Central Hospital of Gynecology Obstetrics, Tianjin, China.Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, China.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

30918032

Citation

Lv, Xiaofang, et al. "A Combination of Mupirocin and Acidic Fibroblast Growth Factor for Nipple Fissure and Nipple Pain in Breastfeeding Women: Protocol for a Randomised, Double-blind, Controlled Trial." BMJ Open, vol. 9, no. 3, 2019, pp. e025526.
Lv X, Feng R, Zhai J. A combination of mupirocin and acidic fibroblast growth factor for nipple fissure and nipple pain in breastfeeding women: protocol for a randomised, double-blind, controlled trial. BMJ Open. 2019;9(3):e025526.
Lv, X., Feng, R., & Zhai, J. (2019). A combination of mupirocin and acidic fibroblast growth factor for nipple fissure and nipple pain in breastfeeding women: protocol for a randomised, double-blind, controlled trial. BMJ Open, 9(3), pp. e025526. doi:10.1136/bmjopen-2018-025526.
Lv X, Feng R, Zhai J. A Combination of Mupirocin and Acidic Fibroblast Growth Factor for Nipple Fissure and Nipple Pain in Breastfeeding Women: Protocol for a Randomised, Double-blind, Controlled Trial. BMJ Open. 2019 Mar 27;9(3):e025526. PubMed PMID: 30918032.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A combination of mupirocin and acidic fibroblast growth factor for nipple fissure and nipple pain in breastfeeding women: protocol for a randomised, double-blind, controlled trial. AU - Lv,Xiaofang, AU - Feng,Rui, AU - Zhai,Jingbo, Y1 - 2019/03/27/ PY - 2019/3/29/entrez PY - 2019/3/29/pubmed PY - 2019/3/29/medline KW - acidic fibroblast growth factor KW - breastfeeding KW - mupirocin KW - nipple fissure KW - nipple pain SP - e025526 EP - e025526 JF - BMJ open JO - BMJ Open VL - 9 IS - 3 N2 - 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. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/30918032/A_combination_of_mupirocin_and_acidic_fibroblast_growth_factor_for_nipple_fissure_and_nipple_pain_in_breastfeeding_women:_protocol_for_a_randomised,_double-blind,_controlled_trial L2 - http://bmjopen.bmj.com/cgi/pmidlookup?view=long&pmid=30918032 DB - PRIME DP - Unbound Medicine ER -
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