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

Tracking Information

First Received Date ^ICMJE

October 8, 2012

Last Updated Date

October 11, 2012

Start Date ^ICMJE

October 2012

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01706341 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

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

Original Other Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

The Effect of Administering a Small Dose of Glucose on the Pregnant Women and Their Neonates During Cesarean Section

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Cesarean Section

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

20 Years to 40 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01706341

Other Study ID Numbers ^ICMJE

NCU-573

Has Data Monitoring Committee

Yes

Responsible Party

Yoshihito Fujita, MD, Nagoya City University

Study Sponsor ^ICMJE

Nagoya City University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Yoshihito Fujita, MD. PhD.

Department of Anesthesiology, Nagoya City Universtiy

Information Provided By

Nagoya City University

Verification Date

October 2012

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

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