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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034605
Receipt No. R000039222
Scientific Title A Family-based prospective cohort study On Women with Psychosocial Problems in the Perinatal Period (FOWPs study)
Date of disclosure of the study information 2018/11/01
Last modified on 2019/10/07

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Basic information
Public title A Family-based prospective cohort study On Women with Psychosocial Problems in the Perinatal Period (FOWPs study)
Acronym A Family-based prospective cohort study On Women with Psychosocial Problems in the Perinatal Period (FOWPs study)
Scientific Title A Family-based prospective cohort study On Women with Psychosocial Problems in the Perinatal Period (FOWPs study)
Scientific Title:Acronym A Family-based prospective cohort study On Women with Psychosocial Problems in the Perinatal Period (FOWPs study)
Region
Japan

Condition
Condition Anxiety disorders, obsessive-compulsive disorders, depressive disorders, bipolar disorders, schizophrenia spectrum and other psychotic disorders, eating disorders, trauma- and stressor-related disorders,dissociative disorders, somatic symptom and related disorders, substance-related disorders, intellectual disabilities, autism spectrum disorder, attention-deficit/hyperactivity disorder, other neurodevelopmental disorders, conditions of other psycho-social problems.And women who have good physical and mental health at the first obstetrical examination as a control group.
Classification by specialty
Obsterics and gynecology Pediatrics Psychiatry
Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this prospective cohort study is to examine outcomes of pregnant women with psycho-social problems and their children and families.
Basic objectives2 Others
Basic objectives -Others To examine outcomes of pregnant women with psycho-social problems and their children and families in this study.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Physical, psychological, and social outcomes of pregnant women with psycho-social problems and their children and families
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
12 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria Pregnant women who visit obstetrics departments of research institutes, and their children and family.
Key exclusion criteria 1) Those who do not wish to participate in this research.
2) Those who are judged inappropriate for participation in this research by the attending physician.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaomi Iyo
Organization Chiba University Graduate School of Medicine
Division name Department of Psychiatry
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL +81-43-26-2148
Email iyom@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tasuku Hashimoto
Organization Chiba University Graduate School of Medicine
Division name Department of Psychiatry
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL +81-43-26-2148
Homepage URL
Email t-hashimoto@faculty.chiba-u.jp

Sponsor
Institute Chiba university
Institute
Department

Funding Source
Organization KAKENHI
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
Email

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 11 Month 01 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
2018 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Chiba university hospital and Asahi Central Hospital are the research institutes of this study.

Management information
Registered date
2018 Year 10 Month 23 Day
Last modified on
2019 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039222

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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