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

Nagoya City University

Status: Unknown

Conditions: Cesarean Section

Treatments: Drug: acetate Ringer's solution containing 1% glucose; Drug: acetate Ringer's solution containing no glucose; Drug: administer acetate Ringer's solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01706341

NCU-573

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

acetate Ringer's solution

Active Comparator group

Description:

Administering acetate Ringer's solution that contains no glucose as an initial infusion A total infusion volume of acetate Ringer's solution is 1500ml

Treatment:

Drug: administer acetate Ringer's solution

Drug: acetate Ringer's solution containing no glucose

acetate Ringer's solution with 1% glucose

Active Comparator group

Description:

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)

Treatment:

Drug: administer acetate Ringer's solution

Drug: acetate Ringer's solution containing 1% glucose