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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000033466
Receipt No. R000038162
Scientific Title The cohort study of mental health for women in perinatal periods in Setagaya Ward
Date of disclosure of the study information 2018/07/21
Last modified on 2018/07/21

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Basic information
Public title The cohort study of mental health for women in perinatal periods in Setagaya Ward
Acronym Setagaya Cohort Study for perinatal mental health
Scientific Title The cohort study of mental health for women in perinatal periods in Setagaya Ward
Scientific Title:Acronym Setagaya Cohort Study for perinatal mental health
Region
Japan

Condition
Condition Women in the perinatal periods
Classification by specialty
Obsterics and gynecology Psychiatry Nursing
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate mental health of women in the perinatal mental health
Basic objectives2 Others
Basic objectives -Others To investigate other psychosocial risk factors for women in the perinatal mental health
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The Japanese version of the Edinburgh Postnatal Depression Scale
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Participants were pregnant women who had been followed up at all the obstetrics outpatient
clinics in the Setagaya ward (14 obstetrics hospitals), were under 20 weeks of gestation and made an appointment to deliver at those clinics.
Key exclusion criteria Exclusion criteria included women with intellectual disability, learning disorders or insufficient level of Japanese to complete the questionnaires, and those who did not deliver at the obstetrics hospitals in the Setagaya ward.
Target sample size 1750

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiko Kubo
Organization National Center for Child Health and Development
Division name Division of Obstetrics, Center for Maternal-Fetal, Neonatal and Reproductive Medicine
Zip code
Address 2-10-1 Okkura, Setagaya-ku, Tokyo
TEL +81-(0)3-3416-0181
Email soratobushirokuma@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyuki Tachibana
Organization National Center for Child Health and Development
Division name Division of Infant and Toddler Mental Health, Department of Psychosocial Medicine
Zip code
Address 2-10-1 Okkura, Setagaya-ku, Tokyo
TEL +81-(0)3-3416-0181
Homepage URL
Email tachibana-y@ncchd.go.jp

Sponsor
Institute National Center for Child Health and Development
Institute
Department

Funding Source
Organization Japanese Ministry of Health, Labour, and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2018 Year 07 Month 21 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2012 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Some results have been published.

Management information
Registered date
2018 Year 07 Month 21 Day
Last modified on
2018 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038162

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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