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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037854
Receipt No. 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 2021/03/09

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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
Obsterics 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 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
Email 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
Email kasa@med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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
Email 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
2022 Year 03 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
2021 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.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


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