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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023973
Receipt No. 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

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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
Obsterics 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
Email 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
Email hayamizu.kengo.906@m.kyushu-u.ac.jp

Sponsor
Institute Kyushu University hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027596

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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