UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034605 |
|---|---|
| Receipt number | 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 | 2024/10/29 14:31:35 |
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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
| Obstetrics 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
| 1 | days-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
500
Research contact person
Name of lead principal investigator
| 1st name | Tomihisa |
| Middle name | |
| Last name | Niitsu |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
+81-43-26-2148
niitsu@chiba-u.jp
Public contact
Name of contact person
| 1st name | Tasuku |
| Middle name | |
| Last name | Hashimoto |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
+81-43-26-2148
Homepage URL
t-hashimoto@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
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
The ethics committee of Chiba University Graduate School of Medicine
Address
1-8-1 Inohana, Chuo-Ku, Chiba-shi, Chiba, 260-8670, Japan
Tel
+81-43-222-7171
inohana-koho@chiba-u.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
| 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
| 2018 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 08 | Month | 31 | Day |
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
| 2024 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039222
