UMIN-CTR Clinical Trial

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 Sumio Middle name Last name Hoka
Organization	Kyushu University
Division name	Department of Anesthesiology and Critical Care Medicine
Zip code	8128582
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 Kana Middle name Last name Hukutoku
Organization	Kyushu University
Division name	Department of Anesthesiology and Critical Care Medicine
Zip code	8128582
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	Kyushu University IRB
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka
Tel	+816425714
Email	ijkseimei@jimu.kyushu-u.ac.jp

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	Published

Result
URL related to results and publications	https://home.hiroshima-u.ac.jp/anesth/aar/
Number of participants that the trial has enrolled	400
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	Completed
Date of protocol fixation	2017 Year 06 Month 15 Day
Date of IRB	2017 Year 06 Month 15 Day
Anticipated trial start date	2017 Year 06 Month 15 Day
Last follow-up date	2019 Year 03 Month 31 Day
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	2019 Year 08 Month 27 Day

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