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

October 11, 2012 updated by: Yoshihito Fujita, MD, Nagoya City University

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Japan
      • Nagoya, Japan, 467-8601
        • Recruiting
        • Departiment of Anesthesiology, Nagoya City University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Saya Yoshizawa, MD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nagoya City University

Investigators

  • Study Chair: Yoshihito Fujita, MD. PhD., Department of Anesthesiology, Nagoya City Universtiy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

October 1, 2013

Study Registration Dates

First Submitted

October 8, 2012

First Submitted That Met QC Criteria

October 11, 2012

First Posted (Estimate)

October 15, 2012

Study Record Updates

Last Update Posted (Estimate)

October 15, 2012

Last Update Submitted That Met QC Criteria

October 11, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCU-573

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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