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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037059
Receipt No. R000042226
Scientific Title The hemodynamics of Labor in Women undergoing Vaginal Deliveries as determined by LIDCO rapid V3
Date of disclosure of the study information 2019/06/15
Last modified on 2019/06/13

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Basic information
Public title The hemodynamics of Labor in Women undergoing Vaginal Deliveries as determined by LIDCO rapid V3
Acronym The hemodynamics of Labor in Women undergoing Vaginal Deliveries as determined by LIDCO rapid V3
Scientific Title The hemodynamics of Labor in Women undergoing Vaginal Deliveries as determined by LIDCO rapid V3
Scientific Title:Acronym The hemodynamics of Labor in Women undergoing Vaginal Deliveries as determined by LIDCO rapid V3
Region
Japan

Condition
Condition Hemodynamic changes during labor of healthy pregnant women
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Hemodynamic changes during delivery
Basic objectives2 Others
Basic objectives -Others Cardiac output
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hemodynamic changes during epidural delivery
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 ASA1-2
Key exclusion criteria The person in charge of research judged it to be inappropriate
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Maiko
Middle name
Last name Satomoto
Organization Toho University
Division name Anesthesiology
Zip code 1438541
Address 6-11-1, Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
TEL 0337624151
Email maiko.satomoto@med.toho-u.ac.jp

Public contact
Name of contact person
1st name Maiko
Middle name
Last name Satomoto
Organization Toho University
Division name Research consultation desk
Zip code 1438541
Address 6-11-1, Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
TEL 0337624151
Homepage URL
Email maiko.satomoto@med.toho-u.ac.jp

Sponsor
Institute Toho University
Institute
Department

Funding Source
Organization Toho University, Department of Anesthesiology
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 Toho University
Address 6-11-1, Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
Tel 0337624151
Email omori.rinri@ext.toho-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

Other administrative information
Date of disclosure of the study information
2019 Year 06 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
2018 Year 12 Month 01 Day
Date of IRB
2019 Year 02 Month 01 Day
Anticipated trial start date
2019 Year 06 Month 15 Day
Last follow-up date
2020 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Analysis data (sample) protects personal information by deleting identifiable personal information (anonymization). In anonymization, random numbering is performed in Excel to create a correspondence table. Also, all information files are used with a password, and the stored USB and paper media information is also stored in a locker locker and not used on PCs that can connect to the Internet environment. Analysis data after the end of the study is stored by a research executor in a locker that takes 10 years.

Management information
Registered date
2019 Year 06 Month 13 Day
Last modified on
2019 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042226

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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