Evidence map›Paper›PMID 30918032›Full record

ArticleBMJ open2019

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.

Xiaofang Lv, Rui Feng, Jingbo Zhai

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.2field-weighted citation impact, top 48% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. Postpartum Nipple Symptoms: Risk Factors and Dermatologic Characterization.Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine · 2021
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 2 institutions in 1 country.

Xiaofang LvGalactophore Department, Tianjin Central Hospital of Gynecology Obstetrics, Tianjin, China.
Rui FengGalactophore Department, Tianjin Central Hospital of Gynecology Obstetrics, Tianjin, China.
Jingbo ZhaiInstitute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
Tianjin Central Hospital of Gynecology Obstetrics · CNTianjin University of Traditional Chinese Medicine · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionNipple 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.

Indexed as

NipplesAdolescentAdultAnti-Bacterial AgentsBreast DiseasesBreast FeedingDouble-Blind MethodDrug Therapy, CombinationFemaleFibroblast Growth Factor 1HumansMiddle AgedMupirocinPainPain ManagementRandomized Controlled Trials as TopicAnti-Bacterial AgentsFibroblast Growth Factor 1Mupirocinacidic fibroblast growth factorbreastfeedingmupirocinnipple fissurenipple pain

Identifiers

PMID30918032
PMCPMC6475339
OpenAlexW2923587274

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.