UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The cohort study of mental health for women in perinatal periods in Setagaya Ward
Title of the study (Brief title)	Setagaya Cohort Study for perinatal mental health
Region	Japan

Condition
Condition	Women in the perinatal periods
Classification by specialty	Obsterics and gynecology Psychiatry Nursing Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate mental health of women in the perinatal mental health
Basic objectives2	Others
Basic objectives -Others	To investigate other psychosocial risk factors for women in the perinatal mental health
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Japanese version of the Edinburgh Postnatal Depression Scale
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Participants were pregnant women who had been followed up at all the obstetrics outpatient clinics in the Setagaya ward (14 obstetrics hospitals), were under 20 weeks of gestation and made an appointment to deliver at those clinics.
Key exclusion criteria	Exclusion criteria included women with intellectual disability, learning disorders or insufficient level of Japanese to complete the questionnaires, and those who did not deliver at the obstetrics hospitals in the Setagaya ward.
Target sample size	1750

Research contact person
Name of lead principal investigator	Takahiko Kubo
Organization	National Center for Child Health and Development
Division name	Division of Obstetrics, Center for Maternal-Fetal, Neonatal and Reproductive Medicine
Address	2-10-1 Okkura, Setagaya-ku, Tokyo
TEL	+81-(0)3-3416-0181
Email	soratobushirokuma@gmail.com

Public contact
Name of contact person	Yoshiyuki Tachibana
Organization	National Center for Child Health and Development
Division name	Division of Infant and Toddler Mental Health, Department of Psychosocial Medicine
Address	2-10-1 Okkura, Setagaya-ku, Tokyo
TEL	+81-(0)3-3416-0181
Homepage URL
Email	tachibana-y@ncchd.go.jp

Sponsor
Institute	National Center for Child Health and Development
Institute
Department

Funding Source
Organization	Japanese Ministry of Health, Labour, and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 07 Month 21 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 09 Month 01 Day
Anticipated trial start date	2012 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	Some results have been published.

Management information
Registered date	2018 Year 07 Month 21 Day
Last modified on	2018 Year 07 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038162