UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036460 |
|---|---|
| Receipt number | 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 11:14:42 |
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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
| Obstetrics 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
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
tomoe.s@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041447
