UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010792
Receipt number 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 09:47:51

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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

Obstetrics 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 or person

Institute

Kyoto University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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