UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of non-invasive continuous arterial pressure monitoring on hemodynamic management of caesarian section
Title of the study (Brief title)	Hemodynamic management of caesarian section
Region	Japan

Condition
Condition	conditions for caesarian section
Classification by specialty	Obsterics and gynecology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether management using with non-invasive continuous blood pressure monitoring can improve maternal and neonatal prognosis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	pH of umbilical arterial blood
Key secondary outcomes	APGAR score of neonate maternal blood pressure change incidence of maternal nausea and vomiting amount of bleeding

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	management using with continuous non-invasive blood pressure monitoring
Interventions/Control_2	management as in the past
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	45 years-old >
Gender	Female
Key inclusion criteria	patient 20 years of age and older patient who can understand and agree to this study
Key exclusion criteria	management with general anesthesia worsening statement of patient in the preoperative period revocation of consent contraindication for the monitor less than 37 weeks of gestation patient with pregnancy induced hypertension multiple pregnancy patient who is not suitable for this study
Target sample size	100

Research contact person
Name of lead principal investigator	Sumio Hoka
Organization	Kyushu University
Division name	Department of Anesthesiology & Critical Care Medicine
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL	092-642-5714
Email	hayamizu.kengo.906@m.kyushu-u.ac.jp

Public contact
Name of contact person	Kengo Hayamizu
Organization	Kyushu University hospital
Division name	Surgical ward
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL	092-642-5714
Homepage URL
Email	hayamizu.kengo.906@m.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University hospital
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2016 Year 09 Month 07 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 09 Month 01 Day
Anticipated trial start date	2016 Year 09 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 09 Month 07 Day
Last modified on	2016 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027596