UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023973 |
|---|---|
| Receipt number | R000027596 |
| Scientific Title | Impact of non-invasive continuous arterial pressure monitoring on hemodynamic management of caesarian section |
| Date of disclosure of the study information | 2016/09/07 |
| Last modified on | 2016/09/07 18:07:44 |
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Basic information
Public title
Impact of non-invasive continuous arterial pressure monitoring on hemodynamic management of caesarian section
Acronym
Hemodynamic management of caesarian section
Scientific Title
Impact of non-invasive continuous arterial pressure monitoring on hemodynamic management of caesarian section
Scientific Title:Acronym
Hemodynamic management of caesarian section
Region
| Japan |
Condition
Condition
conditions for caesarian section
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether management using with non-invasive continuous blood pressure monitoring can improve maternal and neonatal prognosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pH of umbilical arterial blood
Key secondary outcomes
APGAR score of neonate
maternal blood pressure change
incidence of maternal nausea and vomiting
amount of bleeding
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
management using with continuous non-invasive blood pressure monitoring
Interventions/Control_2
management as in the past
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
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
patient 20 years of age and older
patient who can understand and agree to this study
Key exclusion criteria
management with general anesthesia
worsening statement of patient in the preoperative period
revocation of consent
contraindication for the monitor
less than 37 weeks of gestation
patient with pregnancy induced hypertension
multiple pregnancy
patient who is not suitable for this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sumio Hoka |
Organization
Kyushu University
Division name
Department of Anesthesiology & Critical Care Medicine
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5714
hayamizu.kengo.906@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kengo Hayamizu |
Organization
Kyushu University hospital
Division name
Surgical ward
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5714
Homepage URL
hayamizu.kengo.906@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 07 | Day |
Last modified on
| 2016 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027596
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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