UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036460
Receipt No. R000041447
Scientific Title Verification of accuracy of iNIBP(inflationary non-invesive blood pressure) measurement algorithm in pregnant women
Date of disclosure of the study information 2019/04/30
Last modified on 2019/04/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Verification of accuracy of iNIBP(inflationary non-invesive blood pressure) measurement algorithm in pregnant women
Acronym Verification of accuracy of iNIBP(inflationary non-invesive blood pressure) measurement algorithm in pregnant women
Scientific Title Verification of accuracy of iNIBP(inflationary non-invesive blood pressure) measurement algorithm in pregnant women
Scientific Title:Acronym Verification of accuracy of iNIBP(inflationary non-invesive blood pressure) measurement algorithm in pregnant women
Region
Japan

Condition
Condition Pregnant women over 20 weeks gestation
Classification by specialty
Obsterics and gynecology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the measurement accuracy of iNIBP in pregnant women based on the clinical performance test procedure and evaluation method defined in the international standard.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference between blood pressure measured by auscultation method and blood pressure measured by iNIBP
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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Blood pressure measurement using iNIBP.
Perform measurement by auscultation method and measurement by iNIBP alternately, and measure blood pressure nine times in total
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Pregnant women over 20 weeks gestation
Key exclusion criteria use a tocolytic agent(ritodrine hydrochloride preparation, magnesium sulfate preparation),Cases with arrhythmia
Target sample size 45

Research contact person
Name of lead principal investigator
1st name Tomoe
Middle name
Last name Fujita
Organization Kitasato University
Division name Anesthesiology, School of Medicine
Zip code 2520373
Address 1-15-1 Kitasato, Minami Ward, Sagamihara City, Kanagawa
TEL 0427788111
Email tomoe.s@kitasato-u.ac.jp

Public contact
Name of contact person
1st name Tomoe
Middle name
Last name Fujita
Organization Kitasato University
Division name Anesthesiology, School of Medicine
Zip code 2520373
Address 1-15-1 Kitasato, Minami Ward, Sagamihara City, Kanagawa
TEL 0427788111
Homepage URL
Email tomoe.s@kitasato-u.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

Funding Source
Organization Kitasato University
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 Kitasato University,school of medicine,IRB
Address 1-15-1 Kitasato, Minami Ward, Sagamihara City, Kanagawa
Tel 0427788111
Email rinri@med-kitasato-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
2019 Year 04 Month 30 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
2019 Year 04 Month 01 Day
Date of IRB
2019 Year 04 Month 30 Day
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2021 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 10 Day
Last modified on
2019 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041447

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.