The Effect of Administering a Small Dose of Glucose on the Pregnant Women and Their Neonates During Cesarean Section
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The blood glucose concentration in the neonates at one hour of age
研究概览
简要总结
The purpose of this study is to investigate the effect of administering a small dose of glucose on the pregnant women and their neonates during cesarean section. We investigate the safety and efficacy of use of a glucose-containing solution for the pregnant women and the neonates.
详细描述
Rapid infusion of large amount of glucose is associated with fetal hyperglycemia, hyperinsulinemia, and neonatal hypoglycemia. However, the effect of small dose of glucose is unclear. We conducted a pilot study of small dose of glucose. We investigated the effect of a glucose-containing fluid on the blood sugar of the umbilical artery. We found that in the case of no-glucose-containing fluid, there were some cases in which umbilical arterial concentration of glucose was less than 50 mg/dl, which might cause neonatal hypoglycemia. In addition, in the case of 1%-glucose-containing fluid, mean umbilical arterial concentration of glucose was 97 mg/dl.
The purpose of this study is to investigate the effect of administering a small dose of glucose on the pregnant women and their neonates during cesarean section. We investigate the safety and efficacy of use of a glucose-containing solution for the pregnant women and the neonates.
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
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing cesarean section who met the criteria of the American Society of Anesthesiologists physical status of 1-2
排除标准
- •ASA physical status >=3, Obesity (BMI>35), Height>=175cm, Weight>=80Kg
研究组 & 干预措施
acetate Ringer's solution
Administering acetate Ringer's solution that contains no glucose as an initial infusion A total infusion volume of acetate Ringer's solution is 1500ml
干预措施: administer acetate Ringer's solution (Drug)
acetate Ringer's solution
Administering acetate Ringer's solution that contains no glucose as an initial infusion A total infusion volume of acetate Ringer's solution is 1500ml
干预措施: acetate Ringer's solution containing no glucose (Drug)
acetate Ringer's solution with 1% glucose
Administering the acetate Ringer's solution that contains 1% glucose as an initial infusion A total infusion volume of the acetate Ringer's solution containing 1% glucose is 1500ml (containing 15g of glucose)
干预措施: administer acetate Ringer's solution (Drug)
acetate Ringer's solution with 1% glucose
Administering the acetate Ringer's solution that contains 1% glucose as an initial infusion A total infusion volume of the acetate Ringer's solution containing 1% glucose is 1500ml (containing 15g of glucose)
干预措施: acetate Ringer's solution containing 1% glucose (Drug)
结局指标
主要结局
The blood glucose concentration in the neonates at one hour of age
时间窗: One hour of age
次要结局
- The blood glucose concentration in the neonates at two hour of age(Two hour of age)
研究者
Yoshihito Fujita, MD
Associate professor, the department of Anesthesiology
Nagoya City University