UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034053 |
|---|---|
| Receipt number | 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 13:29:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
| Obstetrics 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
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
chiyo@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038816
