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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041611
Receipt No. R000047500
Scientific Title Effects of online medical consultation services on preventing postpartum depression in pregnant women and its social impact: a randomized controlled trial
Date of disclosure of the study information 2020/08/31
Last modified on 2020/08/31

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Basic information
Public title Effects of online medical consultation services on preventing postpartum depression in pregnant women and its social impact: a randomized controlled trial
Acronym Kohoku online medical consultation study
Scientific Title Effects of online medical consultation services on preventing postpartum depression in pregnant women and its social impact: a randomized controlled trial
Scientific Title:Acronym Kohoku online medical consultation study
Region
Japan

Condition
Condition Postpartum depression
Classification by specialty
Obsterics and gynecology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether providing an online medical consultation service to pregnant women can reduce the risk of postpartum depression.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Edinburgh Postnatal Depression Scale at 3-month postpartum
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 The telehealth consultation service "Obstetrics and Gynecology Online/Pediatrics Online" allows for telemedicine consultations with gynecologists, pediatricians, and midwives in the evenings on weekdays, as well as consultations with midwives during the day on weekdays, as many times as needed, from the time of participation in the study until four months postpartum.
Interventions/Control_2 Information only
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 All pregnant women who received the Mother and Child Health Handbook in Kohoku-Ku, Yokohama.
Key exclusion criteria Consent to participate in the study cannot be obtained.
The subject is unable to communicate in Japanese.
Target sample size 720

Research contact person
Name of lead principal investigator
1st name Naoki
Middle name
Last name Kondo
Organization Graduate School of Medicine, The University of Tokyo
Division name Department of Health Education and Health Sociology
Zip code 1130033
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-5841-3513
Email nkondo@m.u-tokyo.ac.jp

Public contact
Name of contact person
1st name Yuki
Middle name
Last name Arakawa
Organization Graduate School of Medicine, The University of Tokyo
Division name Departments of Health and Social Behavior
Zip code 1130033
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-5841-3514
Homepage URL
Email yukiara@m.u-tokyo.ac.jp

Sponsor
Institute The University of Tokyo
Institute
Department

Funding Source
Organization Yokohama city
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization The Research Ethics Review Board of Graduate School of Medicine/Faculty of Medicine, the University of Tokyo
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel 03-5841-0818
Email ethics@m.u-tokyo.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
2020 Year 08 Month 31 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
2020 Year 02 Month 28 Day
Date of IRB
2020 Year 03 Month 16 Day
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2022 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 31 Day
Last modified on
2020 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047500

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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