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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028163
Receipt No. R000032234
Scientific Title Reliability of continuous noninvasive arterial pressure measuring instrument
Date of disclosure of the study information 2017/07/10
Last modified on 2019/01/10

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Basic information
Public title Reliability of continuous noninvasive arterial pressure measuring instrument
Acronym Reliability of continuous noninvasive arterial pressure measuring instrument
Scientific Title Reliability of continuous noninvasive arterial pressure measuring instrument
Scientific Title:Acronym Reliability of continuous noninvasive arterial pressure measuring instrument
Region
Japan

Condition
Condition Pregnant women planning selective caesarean section
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For caesarean section with varied circulatory dynamics, compares the reliability of noninvasive arterial pressure measurement with invasive arterial pressure
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference in measured blood pressure between invasive and noninvasive arterial pressure(Measured up to 10 minutes after birth every minute)
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
18 years-old <=
Age-upper limit
50 years-old >=
Gender Female
Key inclusion criteria Pregnant women(ASA-PS1,2) scheduled for selective caesarean section
Key exclusion criteria Atrial fibrillation, aortic regurgitation, severe pregnancy hypertension, allen test positive
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumihiro Matsuura
Organization Self-Defence Forces Central Hospital
Division name Anethesiology
Zip code
Address 1-2-24 Ikejiri Setagaya-ku, Tokyo
TEL 03-3411-0151
Email fumihirog1012898@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fumihiro Matsuura
Organization Self-Defence Forces Central Hospital
Division name Anesthesiology
Zip code
Address 1-2-24 Ikejiri Setagaya-ku, Tokyo
TEL 03-3411-0151
Homepage URL
Email fumihirog1012898@yahoo.co.jp

Sponsor
Institute Self-Defence Forces Central Hospital
Institute
Department

Funding Source
Organization Self-Defence Forces Central Hospital
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 自衛隊中央病院

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 10 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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In selective caesarean section, invasive arterial pressure and noninvasive arterial pressure are measured and compared every 1 minute from before introduction of anesthesia to 10 minutes after delivery

Management information
Registered date
2017 Year 07 Month 10 Day
Last modified on
2019 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032234

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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