UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045138 |
|---|---|
| Receipt number | R000051566 |
| Scientific Title | Development of postpartum depression prevention program using Maternal and Child Health Handbook application |
| Date of disclosure of the study information | 2021/09/30 |
| Last modified on | 2021/08/12 14:00:35 |
* 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
Development of postpartum depression prevention program using Maternal and Child Health Handbook application
Acronym
Development of postpartum depression prevention program using Maternal and Child Health Handbook application
Scientific Title
Development of postpartum depression prevention program using Maternal and Child Health Handbook application
Scientific Title:Acronym
Development of postpartum depression prevention program using Maternal and Child Health Handbook application
Region
| Japan |
Condition
Condition
postpartum depression
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of postpartum depression prevention programs using the Maternal and Child Health Handbook application.
Basic objectives2
Others
Basic objectives -Others
EPDS
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of EPDS 9 points or more
(One month after delivery)
Key secondary outcomes
Percentage of EPDS 9 points or more
(3,5 months after delivery)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Percentage of EPDS 9 points or more(One month after delivery)
Interventions/Control_2
Percentage of EPDS 9 points or more(3,5months after delivery)
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Pregnant woman
A person who owns a smartphone and can download the electronic mother-child notebook application. Those who have read the explanatory documents before participating in this research, fully understood them, and obtained the voluntary consent of the research subjects.
Key exclusion criteria
People who have difficulty reading and writing Japanese
Target sample size
1800
Research contact person
Name of lead principal investigator
| 1st name | Emiko |
| Middle name | |
| Last name | Nishioka |
Organization
National Defense Medical College
Division name
Department of Maternal Nursing
Zip code
3598513
Address
3-2,Namiki,Tokorozawa,Saitama
TEL
0429951211
nishiemi@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | Emiko |
| Middle name | |
| Last name | Nishioka |
Organization
National Defense Medical College
Division name
Department of Maternal Nursing
Zip code
3598513
Address
3-2,Namiki,Tokorozawa,Saitama
TEL
0429951211
Homepage URL
nishiemi@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Juntendo University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Defense Medical College IRB
Address
3-2,Namiki,Tokorozawa,Saitama
Tel
0429951211
ins010@ndmc.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2020148
Org. issuing International ID_1
3100
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 30 | 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
456
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 12 | Day |
Last modified on
| 2021 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051566
