Efficacy of Adding Azithromycin to Cephalosporin for the Prophylaxis Against Infectious Morbidity Following Cesarean Delivery in High Risk Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- % of women with wound infection
研究概览
简要总结
efficacy of adding azithromycin to cephalosporin before cesarean delivery
详细描述
efficacy of adding azithromycin to cephalosporin for the prophylaxis against infectious morbidity following cesarean delivery in high risk women
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
- Single (Participant)
入排标准
- 年龄范围
- 17 Years 至 39 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age between 17 and 39 years
- •gestaional age between 37 to 42 weeks
- •elective cesarean delivery
- •obese women
排除标准
- •diabetic women on corticosteroids
- •intraopertaive complication in previous section
- •history of septic woun
- •prelabour rupture of membrane >12 hours
研究组 & 干预措施
cephalosporin arm
72 women will receive single antibiotic chemotheraby first generation cephalosporin (cefazolin) 2 gm iv within 30 minutes before skin incision
干预措施: cephalosporin (Drug)
cephalosporin +azithromycin arm
72 women will receive combined antibiotic chemotherapy azithromycin (Azrolid) 1 gm single oral dose 2 hours before cesarean delivery + cephalosporin(Cefazolin) 2 gm iv within 30 minutes before skin incision
干预措施: cephalosporin (Drug)
cephalosporin +azithromycin arm
72 women will receive combined antibiotic chemotherapy azithromycin (Azrolid) 1 gm single oral dose 2 hours before cesarean delivery + cephalosporin(Cefazolin) 2 gm iv within 30 minutes before skin incision
干预措施: Azithromycin Tablets (Drug)
结局指标
主要结局
% of women with wound infection
时间窗: after 14 days post cesarean delivery
superficial and deep surgical site wound infection will be looked for by laboratory confirmation
次要结局
- % of women with postpartum endometritis(after 14 days post cesarean delivery)
研究者
Ghada fayed hashem el sharkawy
principal investigator
Ain Shams University