Ampicillin / Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section: a Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 176
研究概览
简要总结
The efficacy and safety of a single dose of ampicillin/sulbactam compared to a single dose of cefuroxime at cord clamp for prevention of postcesarean infectious morbidity has not been assessed.
Women scheduled for cesarean delivery were randomized to receive a single dose of either 3g of ampicillin-sulbactam or 1.5g of cefuroxime intravenously, after umbilical cord clamping. An evaluation for development of postoperative infections and risk factor analysis was performed.
详细描述
The efficacy and safety of a single dose of ampicillin/sulbactam compared to a single dose of cefuroxime at cord clamp for prevention of postcesarean infectious morbidity has not been assessed.
The investigation was designed to evaluate the efficacy and safety of a single dose of ampicillin/sulbactam 3g compared to a single dose of cefuroxime 1.5g in preventing postoperative morbidity. The primary outcome was development of an infection either at the surgical site or elsewhere e.g. urinary tract infection.
A prospective randomized controlled study was performed from July 2004 to December 2008 in one major tertiary care hospital in Athens Greece. All patients undergoing a cesarean delivery were eligible.Patients were randomly assigned to receive either 1.5g of cefuroxime, or 3g of ampicillin/ sulbactam intravenously after the time the umbilical cord was clamped.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing a cesarean delivery were eligible.
排除标准
- •Patients with known hypersensitivity to penicillin or cephalosporins.
- •Patients who required concomitant antibiotic therapy during surgery.
- •Patients who have received antibiotics during the 72 hours immediately preceding their enrollment.
- •Patients whose postpartum fever was clearly associated with other known causes.
研究组 & 干预措施
ampicillin-sulbactam
This is the drug used to prevent post-cesarean infection
干预措施: Ampicillin-sulbactam (Drug)
ampicillin-sulbactam
This is the drug used to prevent post-cesarean infection
干预措施: Cefuroxime (Drug)
cefuroxime
This drug was compared to ampicillin sulbactam for prevention of infection
干预措施: Ampicillin-sulbactam (Drug)
cefuroxime
This drug was compared to ampicillin sulbactam for prevention of infection
干预措施: Cefuroxime (Drug)