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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027757
Receipt No. R000031807
Scientific Title The study of the association between umbilical pH and blood pressure during cesarean section
Date of disclosure of the study information 2017/06/15
Last modified on 2017/06/14

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Basic information
Public title The study of the association between umbilical pH and blood pressure during cesarean section
Acronym the association between umbilical pH and blood pressure
Scientific Title The study of the association between umbilical pH and blood pressure during cesarean section
Scientific Title:Acronym the association between umbilical pH and blood pressure
Region
Japan

Condition
Condition The patients underwent cesarean section
Classification by specialty
Obsterics and gynecology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine the association between umbilical arterial blood pH.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes BP during cesarean section
umbilical artery pH
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
50 years-old >=
Gender Female
Key inclusion criteria The patients underwent cesarean section in Kyushu University
Key exclusion criteria Fatal dysfunction
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sumio Hoka
Organization Kyushu University
Division name Department of Anesthesiology and Critical Care Medicine
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL +81926425714
Email shoka@kuaccm.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kana Hukutoku
Organization Kyushu University
Division name Department of Anesthesiology and Critical Care Medicine
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL +81926425714
Homepage URL
Email fukutoku.kana.752@m.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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
2017 Year 06 Month 15 Day

Related information
URL releasing protocol http://www.med.kyushu-u.ac.jp/kuaccm/
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information [Acquired Information]
Age, gender, height, weight and medical history (current medical history, past medical history), electrocardiogram, blood pressure / pulse rate, blood test findings (CBC, leukocyte fraction, blood coagulation data (PT, APTT, platelet count)), Observation (operation time, anesthesia time, bleeding volume, umbilical arterial blood pH, Apgar score), postoperative findings (transfusion volume, bleeding volume, blood coagulation data, CRP, CBC, leukocyte fraction, number of hospital days).
Using the data obtained above, we examine the correlation between maternal blood pressure and umbilical arterial blood pH during caesarean section. We also examine the correlation between Shock Index and umbilical arterial blood pH, Apgar score, hospital stay.

Management information
Registered date
2017 Year 06 Month 14 Day
Last modified on
2017 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031807

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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