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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Nagoya City University.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional relevant MeSH terms:
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014