Oral versus intravenous antibiotic prophylaxis before obstetric and gynecological surgical interventions: A randomized clinical trial

IF 2.1 4区医学 Q2 OBSTETRICS & GYNECOLOGY

European journal of obstetrics, gynecology, and reproductive biology Pub Date : 2025-04-29 DOI:10.1016/j.ejogrb.2025.114020

Hatem Abo Elftooh Awaga , Yasmeen Tharwat Anwar, Abdou Saeed Ait-Allah, Amr Othman Abdelkareem

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引用次数: 0

Abstract

Objective

The current study was conducted to compare the efficacy of prophylactic intravenous versus oral (Cephradin) for the prevention of surgical site infections (SSI) in Obstetric and Gynecological interventions.

Methods

A randomized clinical trial was carried out on 230 patients fulfilling the eligibility criteria between 1st October 2023 and 31st July 2024, including pregnant women who were approached prior to their delivery and non-pregnant women who were approached prior to their intended interventions. (group A) 116 patients received oral antimicrobial prophylaxis, while (group B) 114 patients received intravenous antimicrobial prophylaxis. Furthermore, all included patients received oral antibiotics postoperatively (oral cephradine 500 mg/ 12 h for 7 days). Patients were evaluated twice; the 1st assessment was done 1 week, while the 2nd assessment was done a month after the intervention.

Results

SSI rate was 14 % CI (0.07–0.20) in the oral group compared to 13 % CI (0.07–0.20) in the intravenous group after one week with no significant difference in between (p = 0.84). However, the SSI rate was 5.5 % CI (0.02–0.11) in the oral group compared to 6.3 % CI (0.02–0.12) in the intravenous group after one month of the intervention, with no significant difference in between (p = 0.78).

Conclusion

The current study showed that oral antibiotic prophylaxis before obstetric and gynecological interventions seems to be safe, easy, practical, cheap, and as effective as parenteral antibiotic prophylaxis in the prevention of SSI. However, more randomized trials with larger sample sizes are needed to pave the way for replacing parenteral with oral antibiotic chemoprophylaxis.

Trial registration: The study was approved by the Sohag Ethical Committee, Faculty of Medicine, with IRB number (Soh-Med-23-09-05MS) and was registered on clinical trial.gov with T.R.N (NCT06255652).

查看原文本刊更多论文

产科和妇科手术干预前口服与静脉注射抗生素预防：一项随机临床试验

目的比较预防性静脉注射与口服头孢拉西丁预防妇产科手术部位感染（SSI）的疗效。方法在2023年10月1日至2024年7月31日期间，对230例符合入选标准的患者进行随机临床试验，包括在分娩前接触的孕妇和在计划干预前接触的非孕妇。A组116例患者接受口服抗菌药物预防治疗，B组114例患者接受静脉抗菌药物预防治疗。此外，所有患者术后均接受口服抗生素治疗（口服头孢定500 mg/ 12 h，持续7天）。对患者进行两次评估；第一次评估在干预后1周进行，第二次评估在干预后1个月进行。结果1周后口服组sssi发生率为14% CI(0.07 ~ 0.20)，静脉组为13% CI(0.07 ~ 0.20)，两组比较差异无统计学意义（p = 0.84）。然而，干预1个月后，口服组的SSI发生率为5.5% CI(0.02-0.11)，而静脉注射组为6.3% CI(0.02-0.12)，两者无显著差异（p = 0.78）。结论目前的研究表明，在产科和妇科干预措施前口服抗生素预防似乎是安全、简便、实用、廉价的，并且在预防SSI方面与静脉注射抗生素预防一样有效。然而，需要更多的随机试验和更大的样本量，为用口服抗生素化学预防替代肠外治疗铺平道路。试验注册：该研究已获得Sohag医学院伦理委员会批准，IRB号（Soh-Med-23-09-05MS），并在clinical Trial .gov上注册，注册号为T.R.N （NCT06255652）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European journal of obstetrics, gynecology, and reproductive biology 医学-妇产科学

CiteScore

4.60

自引率

3.80%

发文量

898

审稿时长

8.3 weeks

期刊介绍： The European Journal of Obstetrics & Gynecology and Reproductive Biology is the leading general clinical journal covering the continent. It publishes peer reviewed original research articles, as well as a wide range of news, book reviews, biographical, historical and educational articles and a lively correspondence section. Fields covered include obstetrics, prenatal diagnosis, maternal-fetal medicine, perinatology, general gynecology, gynecologic oncology, uro-gynecology, reproductive medicine, infertility, reproductive endocrinology, sexual medicine and reproductive ethics. The European Journal of Obstetrics & Gynecology and Reproductive Biology provides a forum for scientific and clinical professional communication in obstetrics and gynecology throughout Europe and the world.