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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032545
Receipt No. R000037119
Scientific Title Development of fetal audiometry by fetal heart rate measurement
Date of disclosure of the study information 2018/05/11
Last modified on 2018/12/03

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Basic information
Public title Development of fetal audiometry by fetal heart rate measurement
Acronym Fetal audiometry
Scientific Title Development of fetal audiometry by fetal heart rate measurement
Scientific Title:Acronym Fetal audiometry
Region
Japan

Condition
Condition pregnant
Classification by specialty
Obsterics and gynecology Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Fetal audiometry
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in fetal heart rate after acoustic stimulation
Key secondary outcomes

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 20weeks to 37 weeks pregnants
Key exclusion criteria multiple fetuses
Target sample size 20

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 03-3818-3111
Email chiken@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Remi Motegi
Organization Juntendo University
Division name Otorhinolaryngology
Zip code
Address 3-1-3 Hongo Bunkyo-ku Tokyo-to
TEL 03-3818-3111
Homepage URL
Email chiken@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

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
Email

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
2018 Year 05 Month 11 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 Open public recruiting
Date of protocol fixation
2017 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 10 Day
Last modified on
2018 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037119

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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