UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029978 |
|---|---|
| Receipt number | 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 | 2023/05/22 06:30:43 |
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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 | Mari |
| Middle name | |
| Last name | Ikeda |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku
TEL
03-5841-3556
maritake-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Mari |
| Middle name | |
| Last name | Ikeda |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku
TEL
03-5841-3556
Homepage URL
Maritake-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Mari Ikeda
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
Tokyo Women Medical University
Address
8-1 Kawadacho Shinjuku Tokyo
Tel
03-3353-8112
inai.kiyoshi@twmu.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
| 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
| 2023 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034241
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
