UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008175 |
|---|---|
| Receipt number | R000009632 |
| Scientific Title | Measurement of fetal auditory threshold |
| Date of disclosure of the study information | 2012/06/15 |
| Last modified on | 2019/01/13 09:09:07 |
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Basic information
Public title
Measurement of fetal auditory threshold
Acronym
Fetal audiometry
Scientific Title
Measurement of fetal auditory threshold
Scientific Title:Acronym
Fetal audiometry
Region
| Japan |
Condition
Condition
pregnant
Classification by specialty
| Obstetrics and Gynecology | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Fetal audiometry
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Influence of the acoustic stimulation on Pulsatility Index in the fetal Middle Cerebral Artery
Key secondary outcomes
Neonatal auditory screening
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
acoustic stimulation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
28weeks to 33weeks pregnants
Key exclusion criteria
multiple fetuses
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuhisa Ikeda |
Organization
Juntendo University
Division name
Otorhinolaryngology
Zip code
Address
3-1-3 Hongo Bunkyo-ku Tokyo-to
TEL
03-3813-3111
ike@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rina Matsuoka |
Organization
Juntendo University
Division name
Otorhinolaryngology
Zip code
Address
3-1-3 Hongo Bunkyo-ku Tokyo-to
TEL
0338133111
Homepage URL
rmatsu@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
none
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
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
順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2016 | 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
| 2012 | Year | 06 | Month | 14 | Day |
Last modified on
| 2019 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009632
