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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000031409
Receipt No. R000035864
Scientific Title Phenylephrine infusion for prevention of hypotension during spinal anesthesia for elective cesarean section
Date of disclosure of the study information 2018/02/24
Last modified on 2019/01/18

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Basic information
Public title Phenylephrine infusion for prevention
of hypotension during spinal anesthesia for elective cesarean section
Acronym Phenylephrine Infusion for Prevention
of hypotension during spinal anesthesia for elective cesarean section
Scientific Title Phenylephrine infusion for prevention
of hypotension during spinal anesthesia for elective cesarean section
Scientific Title:Acronym Phenylephrine Infusion for Prevention
of hypotension during spinal anesthesia for elective cesarean section
Region
Japan

Condition
Condition elective cesarean section
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 prevention of hypotension
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes incidence of hypotension during elective
cesarean section under spinal anesthesia
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria patients for elective cesarean section under spinal anesthesia
Key exclusion criteria patients who can not communicate
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daiki Nakashima
Organization Gifu University Hospital
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address Gifu Yanagido 1-1
TEL 0582306000
Email isi_m2001046@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daiki Nakashima
Organization Gifu University Hospital
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address Gifu Yanagido 1-1
TEL 0582306000
Homepage URL
Email isi_m2001046@yahoo.co.jp

Sponsor
Institute Gifu University
Institute
Department

Funding Source
Organization Gifu 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
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
2018 Year 02 Month 24 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 Terminated
Date of protocol fixation
2018 Year 02 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Preinitiation

Management information
Registered date
2018 Year 02 Month 21 Day
Last modified on
2019 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035864

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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