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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034053
Receipt No. R000038816
Scientific Title Study of analysis system for fetal heart rate variability using fetal heart Doppler sound obtained by ultrasound cardiograph
Date of disclosure of the study information 2018/10/01
Last modified on 2018/09/06

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Basic information
Public title Study of analysis system for fetal heart rate variability using fetal heart Doppler sound obtained by ultrasound cardiograph
Acronym Study of fetal heart rate variability (FHRV)
Scientific Title Study of analysis system for fetal heart rate variability using fetal heart Doppler sound obtained by ultrasound cardiograph
Scientific Title:Acronym Study of fetal heart rate variability (FHRV)
Region
Japan

Condition
Condition Pregnant women
Classification by specialty
Obsterics and gynecology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop a method to analyze in real time power spectra and cross-spectra from time series data of fetal and mother heart rate variability (HRV) which are recorded simultaneously and continuously
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Power spectra, cross-spectra and relative noise contribution from time series data of fetal and mother heart rate variability (HRV)
Key secondary outcomes Health diagram to simultaneously monitor health state of fetus and mother in real time

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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Health also makes a good pregnant woman the subject with the one of the doctor of obstetrics and gynecology.
Key exclusion criteria The person who doesn't have leave of a doctor of obstetrics and gynecology
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Yoshida
Organization University of Fukui
Division name Department of Obstetrics and Gynecology
Zip code
Address 23-3 Matsuoka,Shimoaiduki,Eiheiji-cho,Yoshida-gun,fukui,Japan
TEL +81-776-61-8392
Email yyoshida@u-fukui.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chiyo Tamamura
Organization University of Fukui
Division name Department of Obstetrics and Gynecology
Zip code
Address 23-3 Matsuoka,Shimoaiduki,Eiheiji-cho,Yoshida-gun,fukui,Japan
TEL +81-776-61-8392
Homepage URL
Email chiyo@u-fukui.ac.jp

Sponsor
Institute University of Fukui
Institute
Department

Funding Source
Organization National University Corporation, Kyoto University.
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 10 Month 01 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
2018 Year 08 Month 03 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information NO

Management information
Registered date
2018 Year 09 Month 06 Day
Last modified on
2018 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038816

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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