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

NCT ID: NCT01706341

Last Updated: 2012-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cesarean Section

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

administer acetate Ringer's solution

Intervention Type DRUG

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

acetate Ringer's solution containing no glucose

Intervention Type DRUG

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)

Group Type ACTIVE_COMPARATOR

administer acetate Ringer's solution

Intervention Type DRUG

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

acetate Ringer's solution containing 1% glucose

Intervention Type DRUG

Interventions

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administer acetate Ringer's solution

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

Intervention Type DRUG

acetate Ringer's solution containing no glucose

Intervention Type DRUG

acetate Ringer's solution containing 1% glucose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nagoya City University

OTHER

Sponsor Role lead

Responsible Party

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Yoshihito Fujita, MD

Associate professor, the department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yoshihito Fujita, MD. PhD.

Role: STUDY_CHAIR

Department of Anesthesiology, Nagoya City Universtiy

Locations

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Departiment of Anesthesiology, Nagoya City University Hospital

Nagoya, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Yoshihito Fujita, MD. PhD.

Role: CONTACT

Phone: +81-52-851-5511

Email: [email protected]

Saya Yoshizawa, MD.

Role: CONTACT

Phone: +52-851-5511

Email: [email protected]

Facility Contacts

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Yoshihito Fujita, MD. PhD.

Role: primary

Saya Yoshizawa, MD.

Role: backup

Other Identifiers

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NCU-573

Identifier Type: -

Identifier Source: org_study_id