The Effect of Administering a Small Dose of Glucose During Cesarean Section
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ClinicalTrials.gov Identifier: NCT01706341 |
Recruitment Status
: Unknown
Verified October 2012 by Yoshihito Fujita, MD, Nagoya City University.
Recruitment status was: Recruiting
First Posted
: October 15, 2012
Last Update Posted
: October 15, 2012
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 (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 |

Arm | Intervention/treatment |
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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
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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
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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)
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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
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- The blood glucose concentration in the neonates at one hour of age [ Time Frame: One hour of age ]
- The blood glucose concentration in the neonates at two hour of age [ Time Frame: Two hour of age ]
- Evidence of clinical complications (especially, low glucose symptoms) [ Time Frame: Within the first 3 days after cesarean section ]

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Ages Eligible for Study: | 20 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706341
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 |
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. |
Study Chair: | Yoshihito Fujita, MD. PhD. | Department of Anesthesiology, Nagoya City Universtiy |
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 Key Record Dates |
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 |