UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019003 |
|---|---|
| Receipt number | R000021957 |
| Scientific Title | Cohort-based study about women's mental health during the perinatal period |
| Date of disclosure of the study information | 2015/09/14 |
| Last modified on | 2025/03/24 15:53:12 |
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Basic information
Public title
Cohort-based study about women's mental health during the perinatal period
Acronym
Cohort-based study about women's mental health during the perinatal period
Scientific Title
Cohort-based study about women's mental health during the perinatal period
Scientific Title:Acronym
Cohort-based study about women's mental health during the perinatal period
Region
| Japan |
Condition
Condition
Depressive disorder with peripartum onset
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Abstraction of usefull information for pregnant woman's mental health
Basic objectives2
Others
Basic objectives -Others
clarify the impact of psychosocial and biological factors on the depressive disorder with peripartum onset
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Edinburgh Postnatal Depression Scale(EPDS)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Pregnant women who give consent to study participation
Key exclusion criteria
under 20 years old / male / inability to understand the questionnaire
written in Japanese
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Norio |
| Middle name | |
| Last name | Ozaki |
Organization
Nagoya University, Graduate School of Medicine
Division name
Pathophysiology of Mental Disorders
Zip code
466-8550
Address
Showaku, Tsurumai-cho 65, Nagoya
TEL
052-744-2285
ozaki-n@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Inagaki |
Organization
Nagoya University, Graduate School of Medicine
Division name
Pathophysiology of Mental Disorders
Zip code
466-8550
Address
Showaku, Tsurumai-cho 65, Nagoya
TEL
052-744-2285
Homepage URL
psy-ozaki-jimu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Ethics Committee of the Nagoya University Graduate School of Medicine
Address
Tsurumaicho 65, showa-ku, Nagoya City, Aichi, Japan
Tel
052-744-2479
ethics@med.nagoya-u.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
| 2015 | Year | 09 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cohort study
We recruit a healthy female without history of psychiatric disorders
Management information
Registered date
| 2015 | Year | 09 | Month | 14 | Day |
Last modified on
| 2025 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021957
