The Effect of Administering a Small Dose of Glucose During Cesarean Section - Full Text View

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 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:

MedlinePlus related topics: Cesarean Section

Drug Information available for: Dextrose

U.S. FDA Resources

Further study details as provided by Yoshihito Fujita, MD, Nagoya City University:

Primary Outcome Measures:

The blood glucose concentration in the neonates at one hour of age [ Time Frame: One hour of age ]

Secondary Outcome Measures:

The blood glucose concentration in the neonates at two hour of age [ Time Frame: Two hour of age ]

Other Outcome Measures:

Evidence of clinical complications (especially, low glucose symptoms) [ Time Frame: Within the first 3 days after cesarean section ]


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 (Adult)
Sexes 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

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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


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

Keywords provided by Yoshihito Fujita, MD, Nagoya City University:


cesarean section intravenous fluid a glucose-containing solution fetal hypoglycemia neonatal hypoglycemia

Additional relevant MeSH terms:


Pharmaceutical Solutions

ClinicalTrials.gov processed this record on June 23, 2017