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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021654
Receipt No. R000024971
Scientific Title Usefulness of the Clearsight system for hemodynamic management in patients undergoing cesarean delivery
Date of disclosure of the study information 2016/03/28
Last modified on 2016/04/09

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Basic information
Public title Usefulness of the Clearsight system for hemodynamic management in patients undergoing cesarean delivery
Acronym The Clearsight system for cesarean delivery
Scientific Title Usefulness of the Clearsight system for hemodynamic management in patients undergoing cesarean delivery
Scientific Title:Acronym The Clearsight system for cesarean delivery
Region
Japan

Condition
Condition Patients undergoing cesarean delivery under spinal anesthesia
Classification by specialty
Obsterics and gynecology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether hemodynamic management using the Clearsight system can prevent the incidence of hypotension induced by spinal anesthesia for cesarean delivery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of hypotension after spinal anesthesia
Key secondary outcomes

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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Hemodynamic management using the Clearsight system
Interventions/Control_2 Hemodynamic management without the Clearsight system
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 undergoing cesarean delivery under spinal anesthesia
Key exclusion criteria 1) Non-reassuring fetal status
2) Systolic blood pressure <80mmHg
3) Arrhythmia
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Suehiro
Organization Osaka City University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code
Address 1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL 06-6645-2186
Email suehirokoichi@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Suehiro
Organization Osaka City University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code
Address 1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL 06-6645-2186
Homepage URL
Email suehirokoichi@yahoo.co.jp

Sponsor
Institute Department of Anesthesiology, Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Anesthesiology, Osaka City University Graduate School of Medicine
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 03 Month 28 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 Open public recruiting
Date of protocol fixation
2016 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information All subjects are divided into "Clearsight group" or "Non-Clearsight group". The incidence of hypotension will be compared between the two groups.

Management information
Registered date
2016 Year 03 Month 28 Day
Last modified on
2016 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024971

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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