UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036545
Receipt No. R000041622
Scientific Title Survey of mental health care and clinical networks for perinatal women with psychosocial risk factors.
Date of disclosure of the study information 2019/04/19
Last modified on 2019/04/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Survey of mental health care and clinical networks for perinatal women with psychosocial risk factors.
Acronym Survey of mental health care and clinical networks for perinatal women with psychosocial risk factors.
Scientific Title Survey of mental health care and clinical networks for perinatal women with psychosocial risk factors.
Scientific Title:Acronym Survey of mental health care and clinical networks for perinatal women with psychosocial risk factors.
Region
Japan

Condition
Condition pregnant and postpartum women with psychosocial risk factors
Classification by specialty
Obsterics and gynecology Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will conduct a survey on the mental health care for pregnant and postpartum women who have mental health problems, as well as how to assess maternal mental health problems and attachment to children (bonding) at maternity hospitals. In addition, we will investigate multidisciplinary mental health care networks for pregnant and postpartum women in Japan.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Mental health assessments at maternity hospitals
2. Mental health care methods at maternity hospitals
3. The state of collaboration with psychiatric services and public health services at maternity hospitals.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Conduct workshop

Contents
Assessment method about mental health (30 minutes)
Mental health care method (30 minutes)
Obstetrics-psychiatry-public health services collaboration method (30 minutes)
Case study meeting (one hour)
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 Male and Female
Key inclusion criteria Maternity hospital in Osaka (138 facilities) , Miyagi (40 facilities), Kagawa (19 facilities),and Oita (51 facilities)
Key exclusion criteria None
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Hitomi
Middle name
Last name Seino
Organization Hyogo college of medicine
Division name Neuropsychiatry
Zip code 6638501
Address 1-1,Mukogawa-cho,Nishinomiya,Hyogo,Japan
TEL +81798456051
Email hitomi-s@hyo-med.ac.jp

Public contact
Name of contact person
1st name Hitomi
Middle name
Last name Seino
Organization Hyogo College of Medicine
Division name Department of Neuropsychiatry
Zip code 6638501
Address 1-1,Mukogawa-cho,Nishinomiya,Hyogo,Japan
TEL +81798456051
Homepage URL
Email hitomi-s@hyo-med.ac.jp

Sponsor
Institute Hyogo college of medicine
Institute
Department

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

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

IRB Contact (For public release)
Organization Hyogo college of medicine
Address 1-1,Mukogawa-cho,Nishinomiya,Hyogo,Japan
Tel +81798456011
Email rinri@hyo-med.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
2019 Year 04 Month 19 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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 19 Day
Date of IRB
Anticipated trial start date
2019 Year 07 Month 01 Day
Last follow-up date
2022 Year 06 Month 30 Day
Date of closure to data entry
2022 Year 11 Month 30 Day
Date trial data considered complete
2022 Year 12 Month 31 Day
Date analysis concluded
2023 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 04 Month 19 Day
Last modified on
2019 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041622

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.