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临床试验/NCT02838940
NCT02838940Unknown3 期

Preventive Antibiotic Serum Levels During Caesarean Section

Tel-Aviv Sourasky Medical Center0 个研究点目标入组 250 人开始时间: 2016年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
250
主要终点
Blood antibiotic levels

研究概览

简要总结

Background

Preventive antibiotic treatment before performing invasive procedures is a basic element in preventing infections. The essence of preventive antibiotic treatment is strengthening the defense mechanisms of the immune system by preserving a certain drug levels in the blood. The timing of giving the antibiotics is very important. Several research groups have tried to check the levels of Cefazolin (the most common antibiotics in the field of obstetrics) in serum and adipose tissue in women during cesarean. These groups presented conflicting research results.

OBJECTIVE

This study will discuss the preventive antibiotic treatment levels accepted prior cesareans, to determine:

  1. What are the factors affecting the level of drug in the blood?
  2. Is there a fixed time which beyond it, blood drug levels are below the MIC(Minimal Inhibitory Concentration)?
  3. Is the provision of usual preventive care also addresses the situations of metabolic disorder?

详细描述

Background

Preventive antibiotic treatment before performing invasive procedures is a basic element in preventing infections. The essence of preventive antibiotic treatment is strengthening the defense mechanisms of the immune system by preserving a certain drug levels in the blood. The timing of giving the antibiotics is very important. Several research groups have tried to check the levels of Cefazolin (the most common antibiotics in the field of obstetrics) in serum and adipose tissue in women during cesarean. These groups presented conflicting research results.

OBJECTIVE

This study will discuss the preventive antibiotic treatment levels accepted prior cesareans, to determine:

  1. What are the factors affecting the level of drug in the blood?
  2. Is there a fixed time which beyond it, blood drug levels are below the MIC(Minimal Inhibitory Concentration)?
  3. Is the provision of usual preventive care also addresses the situations of metabolic disorder?

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Gestational age of 37 weeks and above.
  • Women who arrive to elective cesareans.
  • Age of women: 18-50 years old.

排除标准

  • Suspected clinical / laboratory active infection
  • urgent surgery
  • Sensitivity to penicillin or cephalosporins antibiotics that requires antibiotics change.
  • Women who received the week before surgery antibiotic treatment

研究组 & 干预措施

cesarean in different indications

Experimental

Women that are about to undergo an elective cesarean in different indications.

干预措施: Blood samples. (Procedure)

cesarean in different indications

Experimental

Women that are about to undergo an elective cesarean in different indications.

干预措施: Cefazolin (Drug)

结局指标

主要结局

Blood antibiotic levels

时间窗: 30 min- 2 hours.

Blood MIC(Minimal Inhibitory Concentration) levels of antibiotic will be checked at first incision and at the time of closing surgery.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

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