UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059165 |
|---|---|
| Receipt number | R000067673 |
| Scientific Title | Exploring the Optimal Timing of Paternal Postnatal Depression Screening Based on Longitudinal Changes in the Edinburgh Postnatal Depression Scale-A Prospective Longitudinal Observational Study- |
| Date of disclosure of the study information | 2025/09/23 |
| Last modified on | 2025/09/22 22:50:38 |
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Basic information
Public title
Exploring the Optimal Timing of Paternal Postnatal Depression Screening Based on Longitudinal Changes in the Edinburgh Postnatal Depression Scale-A Prospective Longitudinal Observational Study-
Acronym
Exploration of the Optimal Timing for Paternal Postnatal Depression Screening
Scientific Title
Exploring the Optimal Timing of Paternal Postnatal Depression Screening Based on Longitudinal Changes in the Edinburgh Postnatal Depression Scale-A Prospective Longitudinal Observational Study-
Scientific Title:Acronym
Exploration of the Optimal Timing for Paternal Postnatal Depression Screening
Region
| Japan |
Condition
Condition
postnatal depression
Classification by specialty
| Psychosomatic Internal Medicine | Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we aim to clarify the point prevalence of paternal postpartum depression (PPD) and the longitudinal changes in the Edinburgh Postnatal Depression Scale (EPDS) scores at our institution, in order to explore the optimal timing for implementing paternal PPD screening.
Basic objectives2
Others
Basic objectives -Others
Using maternal data, we will assess the impact of epidural analgesia on the risk of postpartum depression (PPD) by converting the effects into quality of life (QOL) measures, and conduct a cost-effectiveness analysis incorporating the associated medical costs.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Point prevalence of paternal postpartum depression at each time point
Key secondary outcomes
Longitudinal changes in fathers' EPDS scores
Screening implementation rate
Cost-effectiveness of epidural analgesia
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Fathers and mothers of infants born at our facility between September 2025 and August 2026
Key exclusion criteria
If it is difficult to complete the self-administered questionnaire in Japanese
Target sample size
242
Research contact person
Name of lead principal investigator
| 1st name | YUI |
| Middle name | |
| Last name | HAMADA |
Organization
Graduate School of Teikyo University
Division name
Public Health
Zip code
173-8605
Address
2-11-1 Kaga, Itabashi-ku, Tokyo, Japan
TEL
03-3964-1211
25km200164i@stu.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | YUI |
| Middle name | |
| Last name | HAMADA |
Organization
Graduate School of Teikyo University
Division name
Public Health
Zip code
173-8605
Address
2-11-1 Kaga, Itabashi-ku, Tokyo, Japan
TEL
03-3964-1211
Homepage URL
25km200164i@stu.teikyo-u.ac.jp
Sponsor or person
Institute
Graduate School of Teikyo University
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tachikawa Sogo Hospital Ethics Committee
Address
4-1 Midoricho, Tachikawa-shi, Tokyo, Japan
Tel
042-525-2585
no
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
| 2025 | Year | 09 | Month | 23 | 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 | 08 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
At four time points - within a few days after birth, and at 1, 3, and 6 months postpartum - we will conduct surveys using self-administered questionnaires including the Edinburgh Postnatal Depression Scale (EPDS).
Management information
Registered date
| 2025 | Year | 09 | Month | 22 | Day |
Last modified on
| 2025 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067673
