Efficacy of adjunctive azithromycin versus single-dose cephalosporin prophylaxis for caesarean scar defect: study protocol for a randomised controlled trial
| Autor: | Shan Chen, Ding Huang, Yanqing Cai, Hongjie Pan, Qian Zhu, Weiwei Cheng, Liye Shi, Yiru Shi, Min Zeng, Ying Shen, Ben W.J. Mol, Jin Yu, Jian Zhang |
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| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Cost effectiveness medicine.drug_class medicine.medical_treatment Antibiotics Azithromycin caesarean scar defect law.invention Cicatrix Postoperative Complications Randomized controlled trial Double-Blind Method law Pregnancy Internal medicine antibiotic Obstetrics and Gynaecology medicine Humans Caesarean section Pregnancy Complications Infectious azithromycin business.industry Cesarean Section General Medicine Perioperative Antibiotic Prophylaxis Anti-Bacterial Agents Cephalosporins Clinical trial randomised control trial caesarean section Etiology Drug Therapy Combination Female business medicine.drug |
| Zdroj: | BMJ Open |
| ISSN: | 2044-6055 |
| Popis: | IntroductionPerioperative 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 analysisThis 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 disseminationThis 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 numberChiCTR-INR-17013272. |
| Databáze: | OpenAIRE |
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