UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037854 |
|---|---|
| Receipt number | R000043163 |
| Scientific Title | Study of next-generation fetal monitoring diagnostic technology using fetal biosignals |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2024/03/06 09:49:24 |
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Basic information
Public title
Study of next-generation fetal monitoring diagnostic technology using fetal biosignals
Acronym
Study of next-generation fetal monitoring diagnostic technology using fetal biosignals
Scientific Title
Study of next-generation fetal monitoring diagnostic technology using fetal biosignals
Scientific Title:Acronym
Study of next-generation fetal monitoring diagnostic technology using fetal biosignals
Region
| Japan |
Condition
Condition
Pregnant women and their fetuses whose satisfy following conditions.
1)Age: More than 20 years old (the time of informed consent )
2)Pregnant women over 34 weeks pregnant.
Classification by specialty
| Obstetrics and Gynecology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study establishes an objective evaluation method of labor management using newly developed AI for time series analysis, with the time series heart rate change of high-accuracy fetal heart rate chart obtained from fetal biological signals as the main evaluation item.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time-series heart rate change of high-precision fetal heart rate diagram.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Document consent in Japanese has been obtained before participating in the research.
2) Document consent in Japanese has been obtained before participating in the research.
Key exclusion criteria
Pregnant women who need witness in agreement.
The socially vulnerable.
The cases that doctor considered not suitable.
Target sample size
125
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 Fetal Therapeutics, 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
Japan Agency Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyushu University
Kagawa University
Kyoto University
RIKEN
Iwate Medical University
Fukuoka Children's Hospital
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
| 2019 | 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
| 2019 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Compare fetal heart rate chart just before parturition with post-natal Apgar value, cord blood pH, BE.
Management information
Registered date
| 2019 | Year | 08 | Month | 30 | Day |
Last modified on
| 2024 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043163
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
