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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Administering a Small Dose of Glucose on the Pregnant Women and Their Neonates During Cesarean Section

Conditions
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Cesarean Section

Intervention / Treatment
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* Drug: administer acetate Ringer's solution
* Drug: acetate Ringer's solution containing no glucose
* Drug: acetate Ringer's solution containing 1% glucose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: acetate Ringer's solution<br>Administering acetate Ringer's solution that contains no glucose as an initial infusion A total infusion volume of acetate Ringer's solution is 1500ml | Drug: administer acetate Ringer's solution<br>* During cesarean section under spinal anesthesia, each acetate Ringer's solution is administered before delivery.<br>Drug: acetate Ringer's solution containing no glucose<br> <br> |
| Active Comparator: acetate Ringer's solution with 1% glucose<br>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) | Drug: administer acetate Ringer's solution<br>* During cesarean section under spinal anesthesia, each acetate Ringer's solution is administered before delivery.<br>Drug: acetate Ringer's solution containing 1% glucose<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The blood glucose concentration in the neonates at one hour of age |  | One hour of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The blood glucose concentration in the neonates at two hour of age |  | Two hour of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean section, intravenous fluid, a glucose-containing solution, fetal hypoglycemia, neonatal hypoglycemia