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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029978
Receipt No. R000034241
Scientific Title Evaluation of early nursing intervention program to prevent postpartum depression for couples
Date of disclosure of the study information 2017/12/01
Last modified on 2017/11/15

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Basic information
Public title Evaluation of early nursing intervention program to prevent postpartum depression for couples
Acronym Intervention program to prevent postpartum depression
Scientific Title Evaluation of early nursing intervention program to prevent postpartum depression for couples
Scientific Title:Acronym Intervention program to prevent postpartum depression
Region
Japan

Condition
Condition Postpartum depression
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness of the nursing intervention
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes EPDS
Key secondary outcomes K6, PDPI-R, ECR-GO

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Nursing intervention
Interventions/Control_2 non-intervention
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Those who attend antenatal family class.
2) Those who agree to participate in the study and give informed consent after face to face explanation.
Key exclusion criteria 1)Those who a chief investigator judge as inappropriate to participate in the study because of mental disease or relationship problem.
2)Those who cannot speak Japanese and would not be able to answer questionnaires.

Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mari Ikeda
Organization Tokyo Women Medical University
Division name School of Nursing
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-3353-8112
Email Maritake-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mari Ikeda
Organization Tokyo Women Medical University
Division name School of Nursing
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-3353-8112
Homepage URL
Email Maritake-tky@umin.ac.jp

Sponsor
Institute Tokyo Women Medical University
Institute
Department

Funding Source
Organization MEXT
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
2017 Year 12 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 Preinitiation
Date of protocol fixation
2017 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 12 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

Management information
Registered date
2017 Year 11 Month 15 Day
Last modified on
2017 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034241

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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