UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044308 |
|---|---|
| Receipt number | R000050416 |
| Scientific Title | Impact of resilience characteristics and coping on postpartum depression among fathers and mothers: A longitudinal observational study. |
| Date of disclosure of the study information | 2021/05/24 |
| Last modified on | 2021/05/24 20:38:03 |
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Basic information
Public title
Impact of resilience characteristics and coping on postpartum depression among fathers and mothers: A longitudinal observational study.
Acronym
Impact of resilience characteristics and coping on postpartum depression.
Scientific Title
Impact of resilience characteristics and coping on postpartum depression among fathers and mothers: A longitudinal observational study.
Scientific Title:Acronym
Impact of resilience characteristics and coping on postpartum depression.
Region
| Japan |
Condition
Condition
postpartum depression
Classification by specialty
| Obstetrics and Gynecology | Psychiatry | Nursing |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clear how resilience characteristics and coping at 1 month postpartum affect subsequent depressive symptoms among parents.
Basic objectives2
Others
Basic objectives -Others
Exploring related factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postpartum depression (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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Pregnant women and the heterosexual partners
(2) 20 y/o or older
(3) Able to read and write Japanese
Key exclusion criteria
In case which participation to this study until 12 months postpartum is not expected, such as because of severe prognosis on fetus.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Takeishi |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Women's Health Nursing &midwifery
Zip code
9808575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
0227177933
yoko.takeishi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Takeishi |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Women's Health Nursing &midwifery
Zip code
9808575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
0227177933
Homepage URL
yoko.takeishi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku 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
Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
0227177933
yoko.takeishi@med.tohoku.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
| 2021 | Year | 05 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate depressive symptoms and related factors for fathers and mothers 1, 3, 6 and 12 months after childbirth.
Management information
Registered date
| 2021 | Year | 05 | Month | 24 | Day |
Last modified on
| 2021 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050416
