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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010792
Receipt No. R000012630
Scientific Title Association of postnatal neutral development and fetal movement
Date of disclosure of the study information 2013/05/23
Last modified on 2020/05/28

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Basic information
Public title Association of postnatal neutral development and fetal movement
Acronym Evaluation of neural development from fetal period
Scientific Title Association of postnatal neutral development and fetal movement
Scientific Title:Acronym Evaluation of neural development from fetal period
Region
Japan

Condition
Condition Autism spectrum
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The object of this study is to discover new pathological factors which lead to onset of autism spectrum, observing fetal movement by ultrasonography.
Basic objectives2 Others
Basic objectives -Others Discovering new pathological factors
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Onset of autism spectrum at 3 years old
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 In this study, following patients are recruited;
1) preterm labor
2) pregnancy induced hypertension syndrome (preeclampsia)
3) fetal growth restriction
Key exclusion criteria Fetal anomaly is excluded in this study.
Target sample size 220

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ikuo Konishi
Organization Kyoto University Graduate School of Medicine
Division name Department of Gynecology and Obstetrics
Zip code
Address 54 Shogoinkawaharacho, Sakyo-ku, Kyoto, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyoto University Graduate School of Medicine
Division name Department of Gynecology and Obstetrics
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 05 Month 23 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 Enrolling by invitation
Date of protocol fixation
2013 Year 05 Month 09 Day
Date of IRB
2015 Year 11 Month 10 Day
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
2030 Year 11 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Fetal movement is observed by ultrasonography at 1st, 2nd, and 3rd trimester. Simultaneously, vaginal secretion is collected at each point. At delivery, umbilical blood and placenta are collected. If cesarean section is performed, amniotic fluid is collected just before the rupture of membrane. Approximately 1ml of neonatal blood is collected at the 4th day of birth when neonatal mass-screening blood test is performed.
In placenta, mRNA level of 11-beta HSD2 is quantified by quantitative RT-PCR. Cortisol level is assayed in umbilical and neonatal blood. Fetal fibronectin and fibronectin-EDA segment is quantified in vaginal secretion and amniotic fluid.
Neural development of the children is evaluated at 1, 3, 10 months, 1.5 years, and 3 years after birth.

Management information
Registered date
2013 Year 05 Month 23 Day
Last modified on
2020 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012630

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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