UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026503 |
|---|---|
| Receipt number | 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 09:54:13 |
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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
| Obstetrics 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
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
masahiko.nakata@med.toho-u.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology, School of Medicine
Toho University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030439
