UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036738 |
|---|---|
| Receipt number | R000041791 |
| Scientific Title | Exploratory study on the diversity of fetal development |
| Date of disclosure of the study information | 2019/05/20 |
| Last modified on | 2025/05/23 10:09:31 |
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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
| Obstetrics 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.
The following additional studies will also be conducted
This is an addition to the research plan in which a child development questionnaire and a child sleep log will be administered to participants of an exploratory study on the diversity of fetal development at 3 years postpartum.
The purpose of this study is to collect detailed information on child development and sleep status at 3 years postpartum using questionnaires and sleep logs, and to conduct detailed analysis of the relationship between the information obtained continuously from the fetal period and 3 years postpartum.
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.
In addition, a questionnaire on child development at 3 years postpartum and a sleep log for children were conducted.
These will provide important insights for predicting child development from the fetal stage.
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 over 20 years old and up to the 24th week of pregnancy
and their fetuses and live births (in the third year after birth)
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 | Yoshiyuki |
| Middle name | |
| Last name | Kasahara |
Organization
Tohoku University
Division name
Department of Fetal Pathology, Graduate School of Medicine
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7575
yoshiyuki.kasahara.c8@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Kasahara |
Organization
Tohoku University
Division name
Department of Fetal Pathology, Graduate School of Medicine
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7575
Homepage URL
yoshiyuki.kasahara.c8@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
1
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
Completed
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
| 2025 | Year | 03 | Month | 31 | 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
| 2025 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041791
