UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043029 |
|---|---|
| Receipt number | R000049028 |
| Scientific Title | Influence of pregnancy on social cognition and brain function |
| Date of disclosure of the study information | 2021/01/16 |
| Last modified on | 2021/01/20 15:28:01 |
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Basic information
Public title
Influence of pregnancy on social cognition and brain function
Acronym
Influence of pregnancy on social cognition and brain function
Scientific Title
Influence of pregnancy on social cognition and brain function
Scientific Title:Acronym
Influence of pregnancy on social cognition and brain function
Region
| Japan |
Condition
Condition
pregnant women
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Previous studies have reported a transient decline in general cognition, such as memory and executive function during pregnancy. On the other hand, it is assumed that the social cognition of pregnant women will improve in order to adapt to newborn care; however, only a few studies have been reported so far. Therefore,in this study, we aim to clarify whether pregnancy changes social cognition and brain function.
Basic objectives2
Others
Basic objectives -Others
We aim to clarify whether pregnancy causes trade-off between general cognition and social cognition in pregnant woman.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of social cognition due to pregnancy and length of gestation
Key secondary outcomes
Trade-off observed between cognition and brain function due to pregnancy and length of gestation
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
We conduct social cognitive function tests and neuropsychological tests in the first and third trimester of pregnancy.
Interventions/Control_2
We repeat the tests for the control group at intervals of about 6 months.
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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Pregnancy group:
Pregnant women scheduled to give birth for the first time and up to 14 weeks gestation
Control group:
Women who have never been pregnant
Key exclusion criteria
People who satisfies one of the followings;
1. Person who has circulatory organ, liver, kidney, respiratory organs, blood, endocrine, central nervous system diseases and these conditions were judged to be extremely severe or unstable.
2. Person who has psychiatric disorder and the condition was judged to be extremely severe or unstable.
3. Person who has history of head trauma or substance dependence
4. Person with a history of epilepsy or generalized convulsions
Pregnancy group:
1. Person who has had a previous pregnancy of more than 14 weeks.
2. Person who was judged to have an unstable pregnancy course.
Control group:
1. Person who has a history of pregnancy at least once in the past.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Bun |
| Middle name | |
| Last name | Yamagata |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-Ku, Tokyo
TEL
03-5363-3971
yamagata@a6.keio.jp
Public contact
Name of contact person
| 1st name | Fusaka |
| Middle name | |
| Last name | Minami |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-Ku, Tokyo
TEL
03-5363-3971
Homepage URL
minami.fusaka@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University
Address
35 Shinanomachi Shinjuku-Ku, Tokyo
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 16 | 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
| 2021 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 20 | 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
Management information
Registered date
| 2021 | Year | 01 | Month | 16 | Day |
Last modified on
| 2021 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049028
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| Registered date | File name |
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