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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026503
Receipt No. R000030439
Scientific Title Multicenter study for fetal cardiac function by using 2-D tracking method
Date of disclosure of the study information 2017/03/10
Last modified on 2019/03/12

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Basic information
Public title Multicenter study for fetal cardiac function by using 2-D tracking method
Acronym Multicenter study of AutofS
Scientific Title Multicenter study for fetal cardiac function by using 2-D tracking method
Scientific Title:Acronym Multicenter study of AutofS
Region
Japan

Condition
Condition fetus
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish the standard value and/or normal range of fetal AutoFS throughout pregnancy
Basic objectives2 Others
Basic objectives -Others not specified
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes normal value
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 From pregnancy 16 weeks to 41 weeks of gestation
Key exclusion criteria less than 20 years old
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Masahiko
Middle name
Last name Nakata
Organization Toho University
Division name Department of Obstetrics and Gynecology, School of Medicine
Zip code 1430015
Address 6-11-1, Omori-Nishi, Ota-ku, Tokyo
TEL 03-3762-4151
Email masahiko.nakata@med.toho-u.ac.jp

Public contact
Name of contact person
1st name Masahiko
Middle name
Last name Nata
Organization Toho University
Division name Department of Obstetrics and Gynecology, School of Medicine
Zip code 1430015
Address 6-11-1, Omori-Nishi, Ota-ku, Tokyo
TEL 03-3762-4151
Homepage URL
Email masahiko.nakata@med.toho-u.ac.jp

Sponsor
Institute Department of Obstetrics and Gynecology, School of Medicine
Toho University
Institute
Department

Funding Source
Organization Department of Obstetrics and Gynecology, School of Medicine
Toho University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB
Address 5-21-16 Omorinishi, Ota-ku, Tokyo
Tel 03-3762-4151
Email toho.med.kenkyu@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 東邦大学医療センター大森病院、順天堂大学浦安病院、獨協医科大学病院、長良医療センター、川崎医科大学附属病院、高知医療センター

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 10 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 Completed
Date of protocol fixation
2017 Year 03 Month 10 Day
Date of IRB
2016 Year 08 Month 26 Day
Anticipated trial start date
2017 Year 03 Month 10 Day
Last follow-up date
2019 Year 03 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2017 Year 03 Month 10 Day
Last modified on
2019 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030439

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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