跳至主要内容
临床试验/NCT01248078
NCT01248078已完成不适用

Antibiotic Prophylaxis Before Surgery Versus After Cord Clamping in Elective Cesarean Delivery - a Double-blind, Prospective, Randomized Placebo-controlled Trial

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 1,112 人开始时间: 2004年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
1,112
试验地点
1
主要终点
postoperative infectious morbidity

研究概览

简要总结

In this prospective, randomized, placebo controlled trial the investigators were able to demonstrate the usefulness of prophylactic cefazolin in elective caesarean section versus placebo, irrespective of the timing of administration, ie before skin incision or after umbilical cord clamping

详细描述

Background. Perioperative antibiotic prophylaxis during elective cesarean section at term to reduce postoperative maternal infectious morbidity is generally used but may not be efficient based on the available data. Also, the optimal timing of prophylactic antibiotic administration is unclear.

Methods. The investigators compared the effectiveness of cefazolin, administered before skin incision versus after umbilical cord clamping versus placebo in a three-arm randomized trial. The primary endpoint of the study was postoperative infectious morbidity, defined as wound infection, endometritis, or urinary tract infection. Results: The primary outcome was observed in 18/370 women in group 1 (4.9%) and in 14/371 women in group 2 (3.8%), whereas it was noted in 45/371 women in group 3 (12.1%; p<0.001 for group 1 vs. group 3; p<0.001 for group 2 vs. group 3; p<0.001 for group 1 vs. group 2 vs. group 3). The number needed to treat to avoid one primary outcome was 13. Comparing groups 1 and 2, there was no statistically significant difference regarding the primary outcome (p=0.6).

Conclusions. In this prospective, randomized, placebo controlled trial the investigators were able to demonstrate the usefulness of prophylactic cefazolin in elective caesarean section versus placebo, irrespective of the timing of administration, ie before skin incision or after umbilical cord clamping.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Elective cesarean section at term Patientin >18 years Informed consent NO known allergy to cefazolin NO exposure to any antibiotic agent within 1 week prior to delivery

排除标准

  • cesarean section before week 37 cephalosporin allergy age less than 18 years exposure to any antibiotic agent within 1 week prior to delivery

研究组 & 干预措施

Cefazolin A

Active Comparator

administered before skin incision

干预措施: Keflex (Drug)

Cefazolin B

Active Comparator

after umbilical cord clamping

干预措施: Keflex (Drug)

saline solution

Placebo Comparator

administered before skin incision

干预措施: saline solution (Drug)

结局指标

主要结局

postoperative infectious morbidity

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验

Antibiotic Prophylaxis Before Surgery Versus After... | 临床试验