The Effect of Administering a Small Dose of Glucose During Cesarean Section

Not Applicable

• Conditions: Cesarean Section
• Interventions: Drug: administer acetate Ringer's solution; Drug: acetate Ringer's solution containing no glucose; Drug: acetate Ringer's solution containing 1% glucose

• Registration Number: NCT01706341
• Lead Sponsor: Nagoya City University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2012-10
• Study Start: 2012-10
• Study First Submitted: 2012-10-08
• Study First Submitted QC: 2012-10-11
• Last Update Submitted: 2012-10-11
• Study First Posted: 2012-10-15
• Last Update Posted: 2012-10-15
• Primary Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Patients undergoing cesarean section who met the criteria of the American Society of Anesthesiologists physical status of 1-2

Exclusion Criteria

• ASA physical status >=3, Obesity (BMI>35), Height>=175cm, Weight>=80Kg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acetate Ringer's solution	administer 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
acetate Ringer's solution with 1% glucose	administer acetate Ringer's solution	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)
acetate Ringer's solution	acetate Ringer's solution containing no glucose	Administering acetate Ringer's solution that contains no glucose as an initial infusion A total infusion volume of acetate Ringer's solution is 1500ml
acetate Ringer's solution with 1% glucose	acetate Ringer's solution containing 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)

Primary Outcome Measures

Name	Time	Method
The blood glucose concentration in the neonates at one hour of age	One hour of age

Secondary Outcome Measures

Name	Time	Method
The blood glucose concentration in the neonates at two hour of age	Two hour of age

Trial Locations

Locations (1)

Departiment of Anesthesiology, Nagoya City University Hospital; 🇯🇵 Nagoya, Japan