Randomised Trial Comparing Pre-operative Administration of Single Dose Kefazolin to Kefazolin Plus Metronidazole to Reduce Postpartum Infection
试验速览
- 阶段
- 4 期
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Efficacy of reducing surgical site infection
研究概览
简要总结
Randomised controlled trial to investigate the efficacy of adding metronidazole pre-operatively to kefazolin in reducing postpartum infection
详细描述
All pregnant patients scheduled for emergency or elective Caesarean section ≥18 years, willing and able to provide informed consent and not receiving antibiotics, will be eligible for recruitment. Patients will be randomised into receiving kefazolin according to current standard of care administered pre-operatively intravenously with placebo (control arm), and kefazolin according to current standard of care administered pre-operatively with metronidazole 500 mg intravenously pre-operatively. Outcome measures will be surgical site infection, urinary tract infection and postpartum endometritis. Five hundred patients will be recruited in each arm
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 (Outcomes Assessor)
盲法说明
The out comes assessor will not have access to the arm the patient was randomised to.
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
- •18 years and older Willing and able to provide written informed consent
排除标准
- •women younger than 18 years women not able or willing to provide written informed consent women with or without infection already receiving antibiotics for other indications women allergic to kefazolin or metronidazole
研究组 & 干预措施
Intervention arm
This arm will be allocated to receive metronidazole 500 mg in addition to the current standard of care (Kefazolin 1 or 2 grams) administered intravenously prior to skin incision at caesarean section as a once off dose
干预措施: Metronidazole (Drug)
Control arm
This arm will be allocated to receive the current standard of care (Kefazolin 1 or 2 grams) administered intravenously prior to skin incision at caesarean section plus a placebo of normal saline 50 ml administered intravenously as a once off dose
干预措施: Metronidazole (Drug)
结局指标
主要结局
Efficacy of reducing surgical site infection
时间窗: Seven days post-operatively
Incidence of surgical site infections
次要结局
- Efficacy of reducing urinary tact infections(Three days post-operatively)
- Efficacy of reducing postpartum endometritis(Seven days post-operatively)
研究者
Leon Snyman
Prof
University of Pretoria