Comparing of Cefazolin Plus Azithromycin Versus Cefazolin Alone in Prevention of Febrile Morbidity After Emergency Cesarean Delivery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Incidence of febrile morbidity at postoperative day 3
研究概览
简要总结
Cesarean section is the common surgery in world wide. But the complication like febrile morbidity such as surgical site infection, fever, urinary tract infection and endometritis can be occurred even giving the standard antibiotics. Therefore if wider bacterial spectrum coverage antibiotic like azithromycin is added to the standard antimicrobial prophylaxis(1st generation cephalosporin), the incidence of febrile morbidity could be reduced. We will compare the regimen of cefazolin plus azithromycin and standard regimen of cefazolin alone in prevention of febrile morbidity after emergency cesarean section.
详细描述
This study was designed to evaluate the effect of azithromycin on the incidence of febrile morbidity after the emergency cesarean section. The standard antimicrobial prophylaxis which is recommended by the ACOG is the 1st generation cephalosporin intravenously only but some of the bacteria that can cause the febrile morbidity after cesarean section wouldn't be killed by the 1st generation cephalosporin. The antibiotic that can cover them is macrolide group antibiotic such as azithromycin. Therefore this study will compare the regimen of standard antimicrobial prophylaxis and the regimen of standard antimicrobial prophylaxis with azithromycin intravenously in preventing the febrile morbidity after emergency cesarean section. Control group will receive the 1st generation cephalosporin intravenously and the intervention group will receive the 1st generation cephalosporin with azithromycin 500mg intravenously. Primary outcome is febrile morbidity which assessed at postoperative day 3. The definition of the febrile morbidity in this study is including surgical site infection, endometritis, urinary tract infection and fever alone. Secondary outcomes are febrile morbidity at postoperative day 7 and day30, neonatal outcome and adverse effect from azithromycin use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy with a gestation of 24 weeks or more
- •Undergoing non-elective cesarean delivery during labor or rupture of membrane more than 4 hr
- •No allergy to macrolide such as azithromycin and clindamycin
- •Provide informed consent
- •Partner of participant allows the patient to participate the research
排除标准
- •Use of azithromycin within 7 days before enrollment
- •Chorioamnionitis or other infection requiring postpartum antibiotic therapy (except for antibiotics for group B streptococcus)
- •Liver disease (Cirrhosis or AST more than 3 times the upper normal limit)
- •Serum creatinine level of more than 2.0 mg/dL or need dialysis
- •Diarrhea at the time of enrollment
- •Maternal heart disease
- •Use of medication known to prolonged the QT interval
研究组 & 干预措施
Control group (Placebo)
Patient will receive standard antimicrobial prophylaxis(cefazolin intravenously weight dependent) and placebo(0.9% NaCl 100 ml intravenously) before the incision
干预措施: Cefazolin (Drug)
Control group (Placebo)
Patient will receive standard antimicrobial prophylaxis(cefazolin intravenously weight dependent) and placebo(0.9% NaCl 100 ml intravenously) before the incision
干预措施: Sodium Chloride 0.9% Intravenous Solution (Drug)
azithromycin
Patient will receive standard antimicrobial prophylaxis(cefazolin intravenously weight dependent) and azithromycin 500 mg intravenously before the incision
干预措施: Azithromycin Injection [Zithromax] (Drug)
azithromycin
Patient will receive standard antimicrobial prophylaxis(cefazolin intravenously weight dependent) and azithromycin 500 mg intravenously before the incision
干预措施: Cefazolin (Drug)
结局指标
主要结局
Incidence of febrile morbidity at postoperative day 3
时间窗: postoperative day 3
Patient will be assessed at postoperative day 3. Febrile morbidity is including surgical site infection, endometritis, urinary tract infection and fever. There is the questionnaire for the assessor to check if there is the febrile morbidity or not. (There are criteria diagnosis of febrile morbidity from the CDC in the questionnaire)
次要结局
- adverse drug effect(baseline and postoperative day 3, 7 and 30)
- Incidence of adverse Neonatal outcome(baseline and postoperative day 3, 7 and 30)
- Incidence of febrile morbidity at postoperative day 7 and day 30(postoperative day 7 and day 30)