UMIN-CTR Clinical Trial

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

IRB Contact (For public release)
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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/icdr_e/ctr_view.cgi?recptno=R000012630