UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036545
Receipt number 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 2023/04/22 14:58:01

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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

Obstetrics 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

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

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 or person

Institute

Hyogo college of medicine

Institute

Department

Personal name



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

Suspended

Date of protocol fixation

2019 Year 04 Month 19 Day

Date of IRB

2019 Year 05 Month 24 Day

Anticipated trial start date

2019 Year 07 Month 01 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry

2024 Year 03 Month 31 Day

Date trial data considered complete

2024 Year 12 Month 31 Day

Date analysis concluded

2024 Year 12 Month 31 Day


Other

Other related information

The workshop has been postponed due to COVID-19.


Management information

Registered date

2019 Year 04 Month 19 Day

Last modified on

2023 Year 04 Month 22 Day



Link to view the page

Value
https://center6.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