UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032424 |
|---|---|
| Receipt number | 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 21:20:25 |
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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
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
tachibana-y@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036975
