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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005694
Receipt No. R000006732
Scientific Title The effect of administering the different type of plasma substitute on the cord blood gas analysis during cesarean section
Date of disclosure of the study information 2011/06/06
Last modified on 2018/06/08

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Basic information
Public title The effect of administering the different type of plasma substitute on the cord blood gas analysis during cesarean section
Acronym The effect of different plasma substitute on cord blood gas analysis
Scientific Title The effect of administering the different type of plasma substitute on the cord blood gas analysis during cesarean section
Scientific Title:Acronym The effect of different plasma substitute on cord blood gas analysis
Region
Japan

Condition
Condition Patients undergoing cesarean section under spinal anesthesia
Classification by specialty
Obsterics and gynecology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of administering the different type of plasma substitute on the cord blood gas analysis during cesarean section
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare the cord blood gas analysis between administering 6% hydroxyethyl starch that contains a physiologically balanced medium or normal saline solution
Key secondary outcomes To assess the time required from a hysterotomy start to delivery of fetus, hypotensive presence in the anesthesia, the use of the circulation agent, and other complications

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administering 6% hydroxyethyl starch(HES) that contains a physiologically balanced medium as an initial infusion
A total infusion volume of HES is 1500ml
Interventions/Control_2 Administering 6% hydroxyethyl starch(HES) that contains a normal saline solution as an initial infusion
A total infusion volume of HES is 1500ml
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
40 years-old >=
Gender Female
Key inclusion criteria Patients undergoing cesarean section who met the criteria of the American Society of Anesthesiologists physical status of 1-2
Key exclusion criteria ASA physical status >=3, Obesity (BMI>35), Height>=175cm, Weight>=80Kg
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihito Fujita
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Anesthesiology and Medical Crisis Management
Zip code
Address 1 Kawasumi Mizuho-cho Mizuho-ku, Nagoya, Japan
TEL 052-851-5511
Email fujitayoshihito@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihito Fujita
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Anesthesiology and Medical Crisis Management
Zip code
Address 1 kawasumi mizuho-cho mizuho-ku, Nagoya City kawasumi mizuho-cho mizuho-ku, Nagoya City
TEL 052-851-5511
Homepage URL
Email fujitayoshihito@yahoo.co.jp

Sponsor
Institute Department of Anesthesiology and Medical Crisis Management, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
Institute
Department

Funding Source
Organization Nagoya City University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.hoajonline.com/jacs/2049-9752/7/2
Number of participants that the trial has enrolled
Results
To compare the cord blood gas analysis between administering 6% hydroxyethyl starch that contains a physiologically balanced medium or normal saline solution

We found that there are statical differences between Na 135 vs 132 and Cl 109.5 vs 107. However, that had no meaning in critical settings. 
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 06 Month 01 Day
Last modified on
2018 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006732

Research Plan
Registered date File name
2017/11/06 Glu_repository_data1.xlsx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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