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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01706341
Enrollment
40
Registered
2012-10-15
Start date
2012-10-31
Completion date
Unknown
Last updated
2012-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section

Keywords

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

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. 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.

Interventions

DRUGadminister acetate Ringer's solution

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

DRUGacetate Ringer's solution containing no glucose
DRUGacetate Ringer's solution containing 1% glucose

Sponsors

Nagoya City University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The blood glucose concentration in the neonates at one hour of ageOne hour of age

Secondary

MeasureTime frame
The blood glucose concentration in the neonates at two hour of ageTwo hour of age

Other

MeasureTime frame
Evidence of clinical complications (especially, low glucose symptoms)Within the first 3 days after cesarean section

Countries

Japan

Contacts

Primary ContactYoshihito Fujita, MD. PhD.
masui@med.nagoya-cu.ac.jp+81-52-851-5511
Backup ContactSaya Yoshizawa, MD.
sayasaya2002@yahoo.co.jp+52-851-5511

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026