Cesarean SectionNCT01706341
The Effect of Administering a Small Dose of Glucose During Cesarean Section
A study testing administer acetate Ringer's solution, acetate Ringer's solution containing no glucose and acetate Ringer's solution containing 1% glucose in people with Cesarean Section, run by Nagoya City University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- administer acetate Ringer's solution, acetate Ringer's solution containing no glucose and acetate Ringer's solution containing 1% glucose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2012to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing cesarean section who met the criteria of the American Society of Anesthesiologists physical status of 1-2
Who cannot join
- ASA physical status >=3, Obesity (BMI>35), Height>=175cm, Weight>=80Kg
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Departiment of Anesthesiology, Nagoya City University Hospital
Nagoya, 467-8601
Yoshihito Fujita, MD. PhD., +81-52-851-5511 ext. 8281, masui@med.nagoya-cu.ac.jp
Saya Yoshizawa, MD., +52-851-5511 ext. 8281, sayasaya2002@yahoo.co.jp
About this study
Official title: The Effect of Administering a Small Dose of Glucose on the Pregnant Women and Their Neonates During Cesarean Section
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.
Read the 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.
- Conditions
- Cesarean Section
- Being tested
- administer acetate Ringer's solution, acetate Ringer's solution containing no glucose, acetate Ringer's solution containing 1% glucose
- Keywords
- cesarean section, intravenous fluid, a glucose-containing solution, fetal hypoglycemia, neonatal hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
administer acetate Ringer's solutionDrug
During cesarean section under spinal anesthesia, each acetate Ringer's solution is administered before delivery.
acetate Ringer's solution containing no glucoseDrug
acetate Ringer's solution containing 1% glucoseDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Drug: administer acetate Ringer's solution; Drug: acetate Ringer's solution containing 1% glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
The blood glucose concentration in the neonates at one hour of age
Measured: One hour of age
Secondary outcomes (1)
The blood glucose concentration in the neonates at two hour of age
Measured: Two hour of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nagoya City University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoshihito Fujita, MD, Nagoya City University
- Investigators
- Yoshihito Fujita, MD. PhD., Study chair, Department of Anesthesiology, Nagoya City Universtiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706341
- Sponsor's protocol ID
- NCU-573
- Status last verified
- Oct 2012
- First submitted
- 8 Oct 2012
- Last updated
- 15 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Administering a Small Dose of Glucose on the Pregnant Women and Their Neonates During Cesarean Section
- ClinicalTrials.gov ID
- NCT01706341
- Acronym / sponsor ID
- NCU-573
- Conditions
- Cesarean Section
- Keywords
- cesarean section, intravenous fluid, a glucose-containing solution, fetal hypoglycemia, neonatal hypoglycemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nagoya City UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (estimated)
- First posted
- 15 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acetate Ringer's solution | Active comparator | Drug: administer acetate Ringer's solution, Drug: acetate Ringer's solution containing no glucoseAdministering 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 | Drug: administer acetate Ringer's solution, Drug: acetate Ringer's solution containing 1% glucoseAdministering 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) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients undergoing cesarean section who met the criteria of the American Society of Anesthesiologists physical status of 1-2
Key exclusion criteria (1 listed)
- ASA physical status >=3, Obesity (BMI>35), Height>=175cm, Weight>=80Kg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| administer acetate Ringer's solutionDuring cesarean section under spinal anesthesia, each acetate Ringer's solution is administered before delivery. | Drug | 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 |
Primary outcome
The blood glucose concentration in the neonates at one hour of age
Time frame: One hour of age
1 secondary outcome
The blood glucose concentration in the neonates at two hour of age
Time frame: Two hour of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2012.
Related trials for Cesarean Section
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoshihito Fujita, MD. PhD. study chair
Department of Anesthesiology, Nagoya City Universtiy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing administer acetate Ringer's solution, acetate Ringer's solution containing no glucose and acetate Ringer's solution containing 1% glucose in people with Cesarean Section, run by Nagoya City University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoshihito Fujita, MD. PhD. (+81-52-851-5511 ext. 8281, masui@med.nagoya-cu.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The blood glucose concentration in the neonates at one hour of age (time frame: One hour of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2012.