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

This study is currently recruiting participants.
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
History of Changes
  Purpose

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.


Condition Intervention
Cesarean Section
 Drug: administer acetate Ringer's solution
Drug: acetate Ringer's solution containing no glucose
Drug: acetate Ringer's solution containing 1% glucose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Administering a Small Dose of Glucose on the Pregnant Women and Their Neonates During Cesarean Section

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Nagoya City University:

Primary Outcome Measures:
  • The blood glucose concentration in the neonates at one hour of age [ Time Frame: One hour of age ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The blood glucose concentration in the neonates at two hour of age [ Time Frame: Two hour of age ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Evidence of clinical complications (especially, low glucose symptoms) [ Time Frame: Within the first 3 days after cesarean section ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: October 2012
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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
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)
 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 1% glucose

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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706341

Contacts
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

Locations
Japan
Departiment of Anesthesiology, Nagoya City University Hospital Recruiting
Nagoya, Japan, 467-8601
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    
Principal Investigator: Saya Yoshizawa, MD.            
Sponsors and Collaborators
Nagoya City University
Investigators
Study Chair: Yoshihito Fujita, MD. PhD. Department of Anesthesiology, Nagoya City Universtiy
  More Information

No publications provided

Responsible Party: Yoshihito Fujita, MD, Associate professor, the department of Anesthesiology, Nagoya City University
ClinicalTrials.gov Identifier: NCT01706341     History of Changes
Other Study ID Numbers: NCU-573
Study First Received: October 8, 2012
Last Updated: October 11, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Nagoya City University:
cesarean section
intravenous fluid
a glucose-containing solution
fetal hypoglycemia
neonatal hypoglycemia

ClinicalTrials.gov processed this record on May 19, 2013