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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032424
Receipt No. R000036975
Scientific Title Research for the effectiveness of a multi-professional health service intervention program of continuum supports for mother and child which starts for pregnancy periods to enhance maternal mental health
Date of disclosure of the study information 2018/04/29
Last modified on 2019/02/03

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Basic information
Public title Research for the effectiveness of a multi-professional health service intervention program of continuum supports for mother and child which starts for pregnancy periods to enhance maternal mental health
Acronym Suzaka trial
Scientific Title Research for the effectiveness of a multi-professional health service intervention program of continuum supports for mother and child which starts for pregnancy periods to enhance maternal mental health
Scientific Title:Acronym Suzaka trial
Region
Japan

Condition
Condition Mental health problems in perinatal periods
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We hypothesize that the program can enhance postpartum maternal mental health and improve cares for mothers and children. The aim of this study is to examine the hypothesis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The total score of the Edinburgh Postnatal Depression Scale
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Multi-professional health service intervention program of continuum supports for mother and child which starts for pregnancy period
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 The inclusion criterion of this study is women who turned in their pregnancy notification sheets to Suzaka City Office.
Key exclusion criteria There is no exclusion criterion for this study.
Target sample size 300

Research contact person
Name of lead principal investigator
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 Okura, Setagaya-ku, Tokyo, Japan
TEL 03-3416-0181
Email tachibana-y@ncchd.go.jp

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 Okura, Setagaya-ku, Tokyo, Japan
TEL 03-3416-0181
Homepage URL
Email tachibana-y@ncchd.go.jp

Sponsor
Institute National Center for Child Health and Development
Institute
Department

Funding Source
Organization Japan's Ministry of Health, Labour and Welfare and Japan Agency for Medical Research and Development
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 04 Month 29 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 Completed
Date of protocol fixation
2014 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2018 Year 04 Month 29 Day
Date of closure to data entry
2018 Year 04 Month 29 Day
Date trial data considered complete
2018 Year 04 Month 29 Day
Date analysis concluded
2018 Year 04 Month 29 Day

Other
Other related information

Management information
Registered date
2018 Year 04 Month 29 Day
Last modified on
2019 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036975

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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