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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01706341
• Other study ID #: NCU-573
• Status: Recruiting
• Phase: N/A
• First received: October 8, 2012
• Last updated: October 11, 2012
• Start date: October 2012

Study information

• Verified date: October 2012
• Source: Nagoya City University
• Contact: Yoshihito Fujita, MD. PhD.
• Phone: +81-52-851-5511
• Email: masui[@]med.nagoya-cu.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Drug:
• administer acetate Ringer's solution
During cesarean section under spinal anesthesia, each acetate Ringer's solution is administered before delivery.
• acetate Ringer's solution containing no glucose

• acetate Ringer's solution containing 1% glucose

Locations

Country	Name	City	State
Japan	Departiment of Anesthesiology, Nagoya City University Hospital	Nagoya

Sponsors (1)

Lead Sponsor	Collaborator
Nagoya City University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evidence of clinical complications (especially, low glucose symptoms)		Within the first 3 days after cesarean section	Yes
Primary	The blood glucose concentration in the neonates at one hour of age		One hour of age	Yes
Secondary	The blood glucose concentration in the neonates at two hour of age		Two hour of age	Yes