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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040066
Receipt No. R000045678
Scientific Title Effectiveness of circulatory management using esCCO as an index for the prevention of hypotension during cesarean section
Date of disclosure of the study information 2020/04/15
Last modified on 2020/06/27

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Basic information
Public title Effectiveness of circulatory management using esCCO as an index for the prevention of hypotension during cesarean section
Acronym Effectiveness of circulatory management using esCCO as an index for the prevention of hypotension
Scientific Title Effectiveness of circulatory management using esCCO as an index for the prevention of hypotension during cesarean section
Scientific Title:Acronym Effectiveness of circulatory management using esCCO as an index for the prevention of hypotension
Region
Japan

Condition
Condition cesarean section
Classification by specialty
Obsterics and gynecology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the effect of circulatory management using esCCO as an indicator on the prevention of the appearance of hypotension.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Compare the frequency and time of hypotension (systolic blood pressure less than 100 mmHg and mean blood pressure less than 65 mmHg)

Key secondary outcomes Comparison of the vasopressor drug, infusion volume, neonatal apgar score and pH levels between the two groups

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 one group to start hypotension treatment using noninvasive blood pressure measurement to predict the appearance of hypotension .
Interventions/Control_2 and one group to start treatment using esCCO in addition to noninvasive blood pressure measurement to predict the appearance of hypotension .
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 who meet all of the following criteria

1. patients waiting for cesarean section
2. anesthesia method is spinal combined epidural anesthesia
3. over 20 years old
4. patients who have given written consent
Key exclusion criteria Patients who are deemed inappropriate to participate in the study due to serious complications.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Yasuo
Middle name
Last name Yumoto
Organization Fukuoka birth clinic
Division name department of obstetrics
Zip code 819-0006
Address 3-18-21 Meinohamaekiminami, Nishi-ku, Fukuoka
TEL 092-883-0530
Email keny@kuaccm.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name kazuhiro
Middle name
Last name shirozu
Organization kyushu university Hospital
Division name Anesthesia and critical care medicine
Zip code 812-8582
Address 3-1-1 maidashi, higashi-ku, Fukuoka
TEL 092-642-5714
Homepage URL
Email shiron@kuaccm.med.kyushu-u.ac.jp

Sponsor
Institute Fukuoka birth clinic
Institute
Department

Funding Source
Organization Kyushu university hospital
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 Center for Clinical and Translational Research(CCTR)
Address 3-1-1 maidashi, higashi-ku, Fukuoka
Tel 0924079539
Email byskenkyu@jimu.kyushu-u.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 福岡県

Other administrative information
Date of disclosure of the study information
2020 Year 04 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
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 Enrolling by invitation
Date of protocol fixation
2020 Year 03 Month 30 Day
Date of IRB
2020 Year 04 Month 07 Day
Anticipated trial start date
2020 Year 04 Month 15 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 04 Month 06 Day
Last modified on
2020 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045678

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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