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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036738
Receipt No. R000041791
Scientific Title Exploratory study on the diversity of fetal development
Date of disclosure of the study information 2019/05/20
Last modified on 2019/11/19

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Basic information
Public title Exploratory study on the diversity of fetal development
Acronym Exploratory study on the diversity of fetal development
Scientific Title Exploratory study on the diversity of fetal development
Scientific Title:Acronym Exploratory study on the diversity of fetal development
Region
Japan

Condition
Condition Developmental disorder
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To characterize fetal growth restriction
that may lead to development disorders by analyzing fetal bioelectrical signals, maternal life-style and immunological environment, etc.
Basic objectives2 Others
Basic objectives -Others Investigation of new biomarkers for early intervention to fetuses with high risk of developmental disorders.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Bioelectrical signals obtained from fetal electrocardiography, and maternal immune activation assessed by blood analysis.
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 Pregnant women aged 20 and older, whose fetuses are less than 24-week of age.
Key exclusion criteria Pregnant women who need witness in agreement.
The socially vulnerable.
The cases that doctor considered not suitable.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yoshitaka
Middle name
Last name Kimura
Organization Tohoku University
Division name Graduate School of Medicine Disability Science International Disciplinary Biomedical Engineering
Zip code 980-8575
Address 9th Floor of the Building No.5 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL 022-717-7575
Email ykimura@med.tohoku.ac.jp

Public contact
Name of contact person
1st name Yoshiyuki
Middle name
Last name Kasahara
Organization Tohoku University
Division name Graduate School of Medicine Disability Science International Disciplinary Biomedical Engineering
Zip code 980-8575
Address 9th Floor of the Building No.5 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 RIKEN
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Doshisha university
Faculty of medical sciences, Kyushu university
Faculty o f medicine, Kagawa university School of medicine,
Faculty of medicine, Kyoto university Fukuoka Children's Hospital, center for perinatal care
Medical science s innovation hub program, RIKEN
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tohoku University Hospital
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel 022-728-4105
Email rinri-2@proj.med.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 同志社大学(京都府)
九州大学院医学研究院(福岡県)
香川大学医学部(香川県)
東北大学大学院医学系研究科 (宮城県)
京都大学医学部(京都府)
福岡市立こども病院 周産期 センター(福岡県)
理化学研究所医科学イノベーションハブ推進プロ グラム(東京都、神奈川県)

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 20 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 10 Month 10 Day
Date of IRB
2019 Year 01 Month 28 Day
Anticipated trial start date
2019 Year 06 Month 03 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Bioelectrical signals obtained from fetal electrocardiography, cytokines/vitamins in maternal blood and cord blood, and maternal life-style are compared among subjects.

Management information
Registered date
2019 Year 05 Month 14 Day
Last modified on
2019 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041791

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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