UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028163 |
|---|---|
| Receipt number | R000032234 |
| Scientific Title | Reliability of continuous noninvasive arterial pressure measuring instrument |
| Date of disclosure of the study information | 2017/07/10 |
| Last modified on | 2021/07/13 15:13:40 |
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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
| Obstetrics 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
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
fumihirog1012898@yahoo.co.jp
Sponsor or person
Institute
Self-Defence Forces Central Hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 15 | Day |
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
| 2021 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032234
