Efficacy of adjunctive azithromycin versus single-dose cephalosporin prophylaxis for caesarean scar defect: Study protocol for a randomised controlled trial

Yanqing Cai, Hongjie Pan, Jian Zhang, Weiwei Cheng, Yiru Shi, Min Zeng, Liye Shi, Jin Yu, Ying Shen, Shan Chen, Qian Zhu, Ben W. Mol, Ding Huang*

*Corresponding author for this work

Research output: Contribution to journalArticle

1 Downloads (Pure)

Abstract

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.

Original languageEnglish
Article numbere032379
Number of pages6
JournalBMJ Open
Volume10
Issue number1
Early online date7 Jan 2020
DOIs
Publication statusPublished - Jan 2020

Keywords

  • antibiotic
  • azithromycin
  • caesarean scar defect
  • caesarean section
  • randomised control trial
  • ETIOLOGY
  • COST-EFFECTIVENESS
  • SECTION SCAR
  • MORBIDITY
  • NICHE
  • CLOSURE

ASJC Scopus subject areas

  • Medicine(all)

Fingerprint Dive into the research topics of 'Efficacy of adjunctive azithromycin versus single-dose cephalosporin prophylaxis for caesarean scar defect: Study protocol for a randomised controlled trial'. Together they form a unique fingerprint.

  • Cite this

    Cai, Y., Pan, H., Zhang, J., Cheng, W., Shi, Y., Zeng, M., Shi, L., Yu, J., Shen, Y., Chen, S., Zhu, Q., Mol, B. W., & Huang, D. (2020). Efficacy of adjunctive azithromycin versus single-dose cephalosporin prophylaxis for caesarean scar defect: Study protocol for a randomised controlled trial. BMJ Open, 10(1), [e032379]. https://doi.org/10.1136/bmjopen-2019-032379