UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	yoko.takeishi@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050416