UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056950 |
|---|---|
| Receipt number | R000064943 |
| Scientific Title | Effectiveness of Providing Social Support Information to Prevent Postpartum Depression: A Single-Center Historical Control Study |
| Date of disclosure of the study information | 2025/02/06 |
| Last modified on | 2025/02/06 07:25:50 |
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Basic information
Public title
Intervention Study on the Preventive Effects of Providing Social Support Information on Postpartum Depression
Acronym
Intervention Study on the Preventive Effects of Providing Social Support Information on Postpartum Depression
Scientific Title
Effectiveness of Providing Social Support Information to Prevent Postpartum Depression: A Single-Center Historical Control Study
Scientific Title:Acronym
Effectiveness of Providing Social Support Information to Prevent Postpartum Depression: A Single-Center Historical Control Study
Region
| Japan |
Condition
Condition
Postpartum depression
Classification by specialty
| Obstetrics and Gynecology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to verify whether providing information about maternity support services at medical institutions during pregnancy contributes to the prevention of postpartum depression.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in EPDS (Edinburgh Postnatal Depression Scale) Scores at the One-Month Postpartum Checkup
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Researchers will compile information about organizations providing maternity support services with the cooperation of Sendai City and surrounding municipalities and create a website. From June 2025 onwards, all patients visiting the prenatal checkup clinic at our hospital will be directed to the website created by the researchers during their prenatal checkup visits.
Interventions/Control_2
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
(1)Pregnant women who start prenatal check-ups at Tohoku University Hospital by 27 weeks and 6 days of gestation and give birth at Tohoku University Hospital.
(2)Not receiving treatment for any mental disorders.
(3)Possessing a smartphone or computer and having access to the internet.
(4)Able to respond to self-administered questionnaires in Japanese.
Key exclusion criteria
Individuals who experience a miscarriage or stillbirth during the study period.
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | Masatoshi |
| Middle name | |
| Last name | Saito |
Organization
Tohoku University School of Medicine
Division name
Obstetrics
Zip code
9808574
Address
1-1 Seiryomachi, Aoba Ward, Sendai, Miyagi, Japan
TEL
022-717-7255
ob-gy@grp.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Yanagida |
Organization
Tohoku University School of Medicine
Division name
Obstetrics
Zip code
9808574
Address
1-1 Seiryomachi, Aoba Ward, Sendai, Miyagi, Japan
TEL
022-717-7255
Homepage URL
yanagida.junko.r7@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University School of Medicine
Institute
Department
Personal name
Saito, Masatoshi
Funding Source
Organization
Tohoku University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
Tel
022-728-4105
ec-med@grp.tohoku.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
東北大学病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 06 | 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
| 2025 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 06 | Day |
Last modified on
| 2025 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064943
