UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026656 |
|---|---|
| Receipt number | R000030611 |
| Scientific Title | The study for evaluation of fetal cardiac function |
| Date of disclosure of the study information | 2017/03/23 |
| Last modified on | 2017/04/20 13:22:50 |
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Basic information
Public title
The study for evaluation of fetal cardiac function
Acronym
Fetal cardiac funciton
Scientific Title
The study for evaluation of fetal cardiac function
Scientific Title:Acronym
Fetal cardiac funciton
Region
| Japan |
Condition
Condition
singleton pregnancy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the novel technique for fetal cardiac function by ultrasonography
Basic objectives2
Others
Basic objectives -Others
To evaluate fetal echocardiography
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To construct normal range
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
singleton pregnancy
Key exclusion criteria
fetal anomaly, multiple pregnancies
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Nakata |
Organization
Toho University Omori Medical Center
Division name
Department of Obstetrics and Gynecology
Zip code
Address
6-11-1 Omori-Nishi, Ota-Ku, Tokyo
TEL
+81-3-3762-4151
masahiko.nakata@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Nakata |
Organization
Toho University Omori Medical Center
Division name
Department of Obstetrics and Gynecology
Zip code
Address
6-11-1 Omori-Nishi, Ota-Ku, Tokyo
TEL
+81-3-3762-4151
Homepage URL
masahiko.nakata@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center
Institute
Department
Personal name
Funding Source
Organization
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
Address
Tel
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
| 2017 | Year | 03 | Month | 23 | 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
| 2015 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 23 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 23 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
in preparation
Management information
Registered date
| 2017 | Year | 03 | Month | 23 | Day |
Last modified on
| 2017 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030611
