UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025622 |
|---|---|
| Receipt number | R000028978 |
| Scientific Title | Analysis of hemodynamics during elective cesarean section with noninvasive continuous arterial blood pressure monitoring |
| Date of disclosure of the study information | 2017/01/15 |
| Last modified on | 2019/07/18 14:08:42 |
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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
| Obstetrics 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
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
uiakane@gmail.com
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028978
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
