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

NCT01706341 | Unknown DMC

• 1 other identifier: NCU-573
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The blood glucose concentration in the neonates at one hour of age

  One hour of age

Secondary Outcomes (1)

• The blood glucose concentration in the neonates at two hour of age

  Two hour of age

Other Outcomes (1)

• Evidence of clinical complications (especially, low glucose symptoms)

  Within the first 3 days after cesarean section

Study Arms (2)

acetate Ringer's solution

ACTIVE COMPARATOR

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; Drug: acetate Ringer's solution containing no glucose

acetate Ringer's solution with 1% glucose

ACTIVE COMPARATOR

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; Drug: acetate Ringer's solution containing 1% glucose

Interventions

administer acetate Ringer's solution DRUG

During cesarean section under spinal anesthesia, each acetate Ringer's solution is administered before delivery.

acetate Ringer's solution; acetate Ringer's solution with 1% glucose

acetate Ringer's solution containing no glucose DRUG

acetate Ringer's solution

acetate Ringer's solution containing 1% glucose DRUG

acetate Ringer's solution with 1% glucose

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients undergoing cesarean section who met the criteria of the American Society of Anesthesiologists physical status of 1-2

You may not qualify if:

• ASA physical status \>=3, Obesity (BMI\>35), Height\>=175cm, Weight\>=80Kg

Sponsors & Collaborators

• Nagoya City University: lead

Study Sites (1)

Departiment of Anesthesiology, Nagoya City University Hospital

Nagoya, 467-8601, Japan

RECRUITING

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Yoshihito Fujita, MD. PhD.

  Department of Anesthesiology, Nagoya City Universtiy

  STUDY CHAIR

Central Study Contacts

Yoshihito Fujita, MD. PhD.

CONTACT

+81-52-851-5511; masui@med.nagoya-cu.ac.jp

Saya Yoshizawa, MD.

CONTACT

+52-851-5511; sayasaya2002@yahoo.co.jp

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, the department of Anesthesiology

Study Record Dates

• First Submitted: October 8, 2012
• First Posted: October 15, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2013
• Last Updated: October 15, 2012

Record last verified: 2012-10

Locations

JP (1)