UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033466 |
|---|---|
| Receipt number | 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 19:33:32 |
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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
| Obstetrics 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
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
tachibana-y@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038162
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
