UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of hemodynamics during elective cesarean section with noninvasive continuous arterial blood pressure monitoring
Acronym	Analysis of hemodynamics during elective cesarean section with noninvasive continuous arterial blood pressure monitoring
Scientific Title	Analysis of hemodynamics during elective cesarean section with noninvasive continuous arterial blood pressure monitoring
Scientific Title:Acronym	Analysis of hemodynamics during elective cesarean section with noninvasive continuous arterial blood pressure monitoring
Region	Japan

Condition
Condition	pregnancy
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	comprehension of circulation dynamic changes during pregnancy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	arterial blood pressure, cardiac output, cardiac index, stroke volume, and stroke volume variation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	place finger cuff on some finger
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	40 years-old >=
Gender	Female
Key inclusion criteria	20 years old and more
Key exclusion criteria	with peripheral vessel disease
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Hiroaki Middle name Last name Toyama
Organization	Tohoku university school of medicine
Division name	Department of anesthesiology and perioperative medicine
Zip code	9808575
Address	Seiryocho 2-1, Aobaku, Sendai city, MIyagi, Japan
TEL	022-717-7321
Email	h-toyama@umin.ac.jp

Public contact
Name of contact person	1st name Akane Middle name Last name Ui
Organization	Tohoku university school of medicine
Division name	Department of anesthesiology and perioperative medicine
Zip code	9808575
Address	Seiryocho 2-1, Aobaku, Sendai city, MIyagi, Japan
TEL	022-717-7321
Homepage URL
Email	uiakane@gmail.com

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Tohoku University
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	MHLW Certified Clinical Research Review Board, Tohoku University
Address	Seiryo-cho 1-1, Aobaku, Sendai city, Miyagi, Japan
Tel	022-728-4105
Email	hosp-ken@grp.tohoku.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 01 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	15
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 03 Month 31 Day
Date of IRB	2017 Year 02 Month 27 Day
Anticipated trial start date	2017 Year 04 Month 18 Day
Last follow-up date	2018 Year 10 Month 01 Day
Date of closure to data entry	2018 Year 10 Month 01 Day
Date trial data considered complete	2018 Year 10 Month 08 Day
Date analysis concluded	2018 Year 10 Month 09 Day

Other
Other related information

Management information
Registered date	2017 Year 01 Month 11 Day
Last modified on	2019 Year 07 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028978