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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| administer acetate Ringer's solution | Drug | During cesarean section under spinal anesthesia, each acetate Ringer's solution is administered before delivery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The blood glucose concentration in the neonates at one hour of age | One hour of age |
| Measure | Description | Time Frame |
|---|---|---|
| The blood glucose concentration in the neonates at two hour of age | Two hour of age |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of clinical complications (especially, low glucose symptoms) | Within the first 3 days after cesarean section |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yoshihito Fujita, MD. PhD. | Contact | +81-52-851-5511 | 8281 | masui@med.nagoya-cu.ac.jp |
| Saya Yoshizawa, MD. | Contact | +52-851-5511 | 8281 | sayasaya2002@yahoo.co.jp |
| Name | Affiliation | Role |
|---|---|---|
| Yoshihito Fujita, MD. PhD. | Department of Anesthesiology, Nagoya City Universtiy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departiment of Anesthesiology, Nagoya City University Hospital | Recruiting | Nagoya | 467-8601 | Japan |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 11, 2018 | |
| Reset | Oct 4, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 11, 2018 | Oct 4, 2018 |
| ID | Term |
|---|---|
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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| acetate Ringer's solution containing no glucose | Drug |
|
| acetate Ringer's solution containing 1% glucose | Drug |
|