Efficacy of adjunctive azithromycin versus single-dose cephalosporin prophylaxis for caesarean scar defect: study protocol for a randomised controlled trial
INTRODUCTION: Perioperative infections may be considered predictors of caesarean scar defect (CSD), and multidose antibiotics have a protective effect against CSD. However, the ability of adjunctive azithromycin combined with cephalosporin to reduce the prevalence of CSD remains unclear. The planned...
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ftpubmed:oai:pubmedcentral.nih.gov:6955559 2023-05-15T18:15:17+02:00 Efficacy of adjunctive azithromycin versus single-dose cephalosporin prophylaxis for caesarean scar defect: study protocol for a randomised controlled trial Cai, Yanqing Pan, Hongjie Zhang, Jian Cheng, Weiwei Shi, Yiru Zeng, Min Shi, Liye Yu, Jin Shen, Ying Chen, Shan Zhu, Qian Mol, Ben W Huang, Ding 2020-01-07 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6955559/ http://www.ncbi.nlm.nih.gov/pubmed/31915163 https://doi.org/10.1136/bmjopen-2019-032379 en eng BMJ Publishing Group http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6955559/ http://www.ncbi.nlm.nih.gov/pubmed/31915163 http://dx.doi.org/10.1136/bmjopen-2019-032379 © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. CC-BY-NC Obstetrics and Gynaecology Text 2020 ftpubmed https://doi.org/10.1136/bmjopen-2019-032379 2020-02-02T01:16:10Z INTRODUCTION: Perioperative infections may be considered predictors of caesarean scar defect (CSD), and multidose antibiotics have a protective effect against CSD. However, the ability of adjunctive azithromycin combined with cephalosporin to reduce the prevalence of CSD remains unclear. The planned study aims to clarify the protective effect of antibiotics against CSD and to assess the effectiveness of adjunctive azithromycin prophylaxis for CSD. METHODS AND ANALYSIS: This study is a double-blind, parallel-control randomised clinical trial that will be carried out at the International Peace Maternity and Child Health Hospital. A total of 220 eligible patients will be randomised (1:1) to receive either adjunctive azithromycin or single-dose cephalosporin 30 min before the incision. The evaluation criteria are the prevalence and characteristics of CSD as assessed by transvaginal ultrasound (TVU) and saline infusion sonohysterography (SIS) at 42 days, 6 months and 12 months after delivery. The primary outcome will be the prevalence of CSD, and the characteristics of CSD will be assessed by TVU and SIS 42 days after delivery; all other outcomes are secondary. ETHICS AND DISSEMINATION: This protocol received authorisation from the Medical Research Ethics Committee of International Peace Maternity and Child Health Hospital on 25 April 2018 (approval no. GKLW2017-84). The findings will be reported in peer-reviewed publications and presentations at international scientific meetings. TRIAL REGISTRATION NUMBER: ChiCTR-INR-17013272. Text SCAR PubMed Central (PMC) BMJ Open 10 1 e032379 |
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Obstetrics and Gynaecology Cai, Yanqing Pan, Hongjie Zhang, Jian Cheng, Weiwei Shi, Yiru Zeng, Min Shi, Liye Yu, Jin Shen, Ying Chen, Shan Zhu, Qian Mol, Ben W Huang, Ding Efficacy of adjunctive azithromycin versus single-dose cephalosporin prophylaxis for caesarean scar defect: study protocol for a randomised controlled trial |
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Obstetrics and Gynaecology |
description |
INTRODUCTION: Perioperative infections may be considered predictors of caesarean scar defect (CSD), and multidose antibiotics have a protective effect against CSD. However, the ability of adjunctive azithromycin combined with cephalosporin to reduce the prevalence of CSD remains unclear. The planned study aims to clarify the protective effect of antibiotics against CSD and to assess the effectiveness of adjunctive azithromycin prophylaxis for CSD. METHODS AND ANALYSIS: This study is a double-blind, parallel-control randomised clinical trial that will be carried out at the International Peace Maternity and Child Health Hospital. A total of 220 eligible patients will be randomised (1:1) to receive either adjunctive azithromycin or single-dose cephalosporin 30 min before the incision. The evaluation criteria are the prevalence and characteristics of CSD as assessed by transvaginal ultrasound (TVU) and saline infusion sonohysterography (SIS) at 42 days, 6 months and 12 months after delivery. The primary outcome will be the prevalence of CSD, and the characteristics of CSD will be assessed by TVU and SIS 42 days after delivery; all other outcomes are secondary. ETHICS AND DISSEMINATION: This protocol received authorisation from the Medical Research Ethics Committee of International Peace Maternity and Child Health Hospital on 25 April 2018 (approval no. GKLW2017-84). The findings will be reported in peer-reviewed publications and presentations at international scientific meetings. TRIAL REGISTRATION NUMBER: ChiCTR-INR-17013272. |
format |
Text |
author |
Cai, Yanqing Pan, Hongjie Zhang, Jian Cheng, Weiwei Shi, Yiru Zeng, Min Shi, Liye Yu, Jin Shen, Ying Chen, Shan Zhu, Qian Mol, Ben W Huang, Ding |
author_facet |
Cai, Yanqing Pan, Hongjie Zhang, Jian Cheng, Weiwei Shi, Yiru Zeng, Min Shi, Liye Yu, Jin Shen, Ying Chen, Shan Zhu, Qian Mol, Ben W Huang, Ding |
author_sort |
Cai, Yanqing |
title |
Efficacy of adjunctive azithromycin versus single-dose cephalosporin prophylaxis for caesarean scar defect: study protocol for a randomised controlled trial |
title_short |
Efficacy of adjunctive azithromycin versus single-dose cephalosporin prophylaxis for caesarean scar defect: study protocol for a randomised controlled trial |
title_full |
Efficacy of adjunctive azithromycin versus single-dose cephalosporin prophylaxis for caesarean scar defect: study protocol for a randomised controlled trial |
title_fullStr |
Efficacy of adjunctive azithromycin versus single-dose cephalosporin prophylaxis for caesarean scar defect: study protocol for a randomised controlled trial |
title_full_unstemmed |
Efficacy of adjunctive azithromycin versus single-dose cephalosporin prophylaxis for caesarean scar defect: study protocol for a randomised controlled trial |
title_sort |
efficacy of adjunctive azithromycin versus single-dose cephalosporin prophylaxis for caesarean scar defect: study protocol for a randomised controlled trial |
publisher |
BMJ Publishing Group |
publishDate |
2020 |
url |
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6955559/ http://www.ncbi.nlm.nih.gov/pubmed/31915163 https://doi.org/10.1136/bmjopen-2019-032379 |
genre |
SCAR |
genre_facet |
SCAR |
op_relation |
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6955559/ http://www.ncbi.nlm.nih.gov/pubmed/31915163 http://dx.doi.org/10.1136/bmjopen-2019-032379 |
op_rights |
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
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CC-BY-NC |
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https://doi.org/10.1136/bmjopen-2019-032379 |
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BMJ Open |
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10 |
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