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...
Published in: | BMJ Open |
---|---|
Main Authors: | , , , , , , , , , , , , |
Other Authors: | , |
Format: | Article in Journal/Newspaper |
Language: | English |
Published: |
BMJ
2020
|
Subjects: | |
Online Access: | http://dx.doi.org/10.1136/bmjopen-2019-032379 https://syndication.highwire.org/content/doi/10.1136/bmjopen-2019-032379 |
id |
crjcrbmj:10.1136/bmjopen-2019-032379 |
---|---|
record_format |
openpolar |
spelling |
crjcrbmj:10.1136/bmjopen-2019-032379 2024-06-23T07:56:36+00:00 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 medical engineering cross youth funds from Shanghai Jiao Tong University Shanghai Shenkang Hospital Development Center Clinical Science and Technology Innovation Project 2020 http://dx.doi.org/10.1136/bmjopen-2019-032379 https://syndication.highwire.org/content/doi/10.1136/bmjopen-2019-032379 en eng BMJ http://creativecommons.org/licenses/by-nc/4.0/ BMJ Open volume 10, issue 1, page e032379 ISSN 2044-6055 2044-6055 journal-article 2020 crjcrbmj https://doi.org/10.1136/bmjopen-2019-032379 2024-05-24T13:16:13Z 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. Article in Journal/Newspaper SCAR The BMJ BMJ Open 10 1 e032379 |
institution |
Open Polar |
collection |
The BMJ |
op_collection_id |
crjcrbmj |
language |
English |
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. |
author2 |
medical engineering cross youth funds from Shanghai Jiao Tong University Shanghai Shenkang Hospital Development Center Clinical Science and Technology Innovation Project |
format |
Article in Journal/Newspaper |
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 |
spellingShingle |
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 |
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 |
publishDate |
2020 |
url |
http://dx.doi.org/10.1136/bmjopen-2019-032379 https://syndication.highwire.org/content/doi/10.1136/bmjopen-2019-032379 |
genre |
SCAR |
genre_facet |
SCAR |
op_source |
BMJ Open volume 10, issue 1, page e032379 ISSN 2044-6055 2044-6055 |
op_rights |
http://creativecommons.org/licenses/by-nc/4.0/ |
op_doi |
https://doi.org/10.1136/bmjopen-2019-032379 |
container_title |
BMJ Open |
container_volume |
10 |
container_issue |
1 |
container_start_page |
e032379 |
_version_ |
1802649847200743424 |