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临床试验/NCT04009772
NCT04009772Unknown2 期

Single Dose Cefepime Versus Cefuroxime Plus Metronidazole as a Prophylactic Antibiotic: A Randomized Controlled Study

Assiut University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
500
试验地点
1
主要终点
Incidence of surgical site wound infection

研究概览

简要总结

Compare between cefepime versus routine antibiotics as a prophylactic antibiotic during emergency cesarean section in a tertiary center of obstetric care

详细描述

This is a randomized double blinded study which compare between single dose cefepime versus cefuroxime plus metronidazole during emergency intrapartum cesarean section.

Outcomes will include fever, wound infection, and urinary tract infection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • intrapartum caesarean section

排除标准

  • evidence of infection

研究组 & 干预措施

"Cefepime" , "Maxipime®" 1 gm

Active Comparator

Patient will receive "Cefepime" ,"Maxipime®" 1 gm IV during cesarean section just before skin incision

干预措施: Cefepime (Drug)

"Cefuroxime", "Zinnat®" 1gm plus "metronidazole"Flagyl®" 500

Active Comparator

Patient will receive "Cefuroxime", "Zinnat®" 1gm ,and "metronidazole"Flagyl®" 500 IV; just before skin incision for emergency cesarean section

干预措施: Cefuroxime plus Metronidazole (Drug)

结局指标

主要结局

Incidence of surgical site wound infection

时间窗: one week

Examining the wound after one week of the surgery to detect any infection

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Osama Saber Thabet Abdalmageed

Consultant of Obstetrics and gynecology

Assiut University

研究点 (1)

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