UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043555 |
|---|---|
| Receipt number | R000049705 |
| Scientific Title | Exploratory study of fetal EEG signal extraction technology using existing data by maternal abdominal wall. |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2024/03/13 09:08:03 |
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Basic information
Public title
Exploratory study of fetal EEG signal extraction technology using existing data by maternal abdominal wall.
Acronym
Exploratory study of fetal EEG signal extraction technology using existing data by maternal abdominal wall.
Scientific Title
Exploratory study of fetal EEG signal extraction technology using existing data by maternal abdominal wall.
Scientific Title:Acronym
Exploratory study of fetal EEG signal extraction technology using existing data by maternal abdominal wall.
Region
| Japan |
Condition
Condition
Use existing information
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will conduct exploratory research on a new technique to extract and accurately separate fetal cardiac and fetal electroencephalographic signals simultaneously using raw data of biological signals collected by the maternal abdominal wall guidance method in clinical studies and clinical trials conducted in the past at Tohoku University Hospital.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency spectrum analysis is performed to confirm that the results extracted from the RAW data of biological signals by the maternal abdominal wall induction method are fetal-derived EEG signals. In addition, the fetal heart rate obtained at the same time is evaluated.
In addition, the stage of sleep of the fetus is estimated from the fetal heart rate chart obtained at the same time, and the relationship with EEG is examined and evaluated.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Data collected from two clinical studies and one clinical trial conducted at Tohoku University Hospital in the past will be included.
1.Title of research: Clinical research using fetal electrocardiogram
Research period: August 2009 - March 2019
Date of approval(most recent): April 11, 2014 (receipt number: 2014-1-23)
Number of cases: 245
2.Title of the study: Registry study of fetal bio-signals using a new abdominal wall guidance method
Research period: August 2015 - March 2019
Date of approval(most recent): December 12, 2018 (receipt number: 2018-2-242)
Number of cases: 158 cases (only cases registered at Tohoku University Hospital)
3.Clinical trial title: Efficacy and safety evaluation study of Monitor 138
Clinical trial period: February, 2013 - January, 2015
Number of cases: 23
Key exclusion criteria
None
Target sample size
426
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Kasahara |
Organization
Tohoku University
Division name
Department of Maternal and Fetal Therapeutics, Graduate School of Medicine
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7575
kasa@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Kasahara |
Organization
Tohoku University
Division name
Department of Maternal and Child Health Care Medical Science, Graduate School of Medicine
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7575
Homepage URL
kasa@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Joint research funding from Tohoku University and Khalifa University, United Arab Emirates
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
United Arab Emirates
Other related organizations
Co-sponsor
Khalifa University, United Arab Emirates
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.jp
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
| 2021 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
From the RAW data obtained by the maternal abdominal wall induction method, we separate the fetal-derived biological signals using the existing fetal electrocardiogram analysis algorithm (BSSR) and perform frequency spectrum analysis. In addition, these results are checked for the presence of EEG-specific frequency bands (e.g., gamma, delta, theta, alpha, beta, etc.) and used as supervisory data for time series AI.
Then, only the fetal-derived bio-signals are separated from the raw data induced by maternal abdominal wall guidance using the existing fetal ECG analysis algorithm as well. Here, the EEG signal is separated from the fetal-derived bio-signal using the trained time series AI.
Management information
Registered date
| 2021 | Year | 03 | Month | 09 | Day |
Last modified on
| 2024 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049705
| Research Plan | |
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| Registered date | File name |
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| Research case data | |
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