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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Nagoya City University
Sponsor:
Information provided by (Responsible Party):
Yoshihito Fujita, MD, Nagoya City University
ClinicalTrials.gov Identifier:
NCT01706341
First received: October 8, 2012
Last updated: October 11, 2012
Last verified: October 2012

October 8, 2012
October 11, 2012
October 2012
October 2013   (final data collection date for primary outcome measure)
The blood glucose concentration in the neonates at one hour of age [ Time Frame: One hour of age ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01706341 on ClinicalTrials.gov Archive Site
The blood glucose concentration in the neonates at two hour of age [ Time Frame: Two hour of age ] [ Designated as safety issue: Yes ]
Same as current
Evidence of clinical complications (especially, low glucose symptoms) [ Time Frame: Within the first 3 days after cesarean section ] [ Designated as safety issue: Yes ]
Same as current
 
The Effect of Administering a Small Dose of Glucose During Cesarean Section
The Effect of Administering a Small Dose of Glucose on the Pregnant Women and Their Neonates During Cesarean Section

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Cesarean Section
  • Drug: administer acetate Ringer's solution
    During cesarean section under spinal anesthesia, each acetate Ringer's solution is administered before delivery.
  • Drug: acetate Ringer's solution containing no glucose
  • Drug: acetate Ringer's solution containing 1% glucose
  • Active Comparator: 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
    Interventions:
    • Drug: administer acetate Ringer's solution
    • Drug: acetate Ringer's solution containing no glucose
  • Active Comparator: 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)
    Interventions:
    • Drug: administer acetate Ringer's solution
    • Drug: acetate Ringer's solution containing 1% glucose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
October 2013   (final data collection date for primary outcome measure)

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
Female
20 Years to 40 Years
No
Contact: Yoshihito Fujita, MD. PhD. +81-52-851-5511 ext 8281 masui@med.nagoya-cu.ac.jp
Contact: Saya Yoshizawa, MD. +52-851-5511 ext 8281 sayasaya2002@yahoo.co.jp
Japan
 
NCT01706341
NCU-573
Yes
Yoshihito Fujita, MD, Nagoya City University
Nagoya City University
Not Provided
Study Chair: Yoshihito Fujita, MD. PhD. Department of Anesthesiology, Nagoya City Universtiy
Nagoya City University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP