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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Cesarean Section	Drug: administer acetate Ringer's solution; Drug: acetate Ringer's solution containing no glucose; Drug: acetate Ringer's solution containing 1% glucose	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (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
Study Start Date :	October 2012
Estimated Primary Completion Date :	October 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Other Outcome Measures:

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	October 15, 2012
Last Update Posted:	October 15, 2012
Last Verified:	October 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