UMIN-CTR Clinical Trial

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
Email	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
Email	nishiemi@ndmc.ac.jp

Sponsor
Institute	National Defense Medical College
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051566