UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049379 |
|---|---|
| Receipt number | R000056221 |
| Scientific Title | A retrospective study of factors associated with Edinburgh Postnatal Depression Scale in the early postpartum period |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2026/01/22 07:53:29 |
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Basic information
Public title
A retrospective study of factors associated with Edinburgh Postnatal Depression Scale in the early postpartum period
Acronym
A retrospective study of factors associated with Edinburgh Postnatal Depression Scale in the early postpartum period
Scientific Title
A retrospective study of factors associated with Edinburgh Postnatal Depression Scale in the early postpartum period
Scientific Title:Acronym
A retrospective study of factors associated with Edinburgh Postnatal Depression Scale in the early postpartum period
Region
| Japan |
Condition
Condition
Postpartum
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A retrospective study of factors associated with Edinburgh Postnatal Depression Scale (EPDS) in the early postpartum period using a single-center medical record.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Factors associated with EPDS
Key secondary outcomes
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
| 10 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Women who Administered the EPDS at 2- and 4-week postpartum examinations
Key exclusion criteria
1. Women who failed to Administer the EPDS at 2- and 4-week postpartum examinations
2. Women who can't speak Japanese
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Okutomi |
Organization
Kitasato University School of Medicine
Division name
Department of Anesthesiology
Zip code
252-0375
Address
1-15-1, Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
TEL
042-778-8606
tokutomi@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Hyuga |
Organization
Kitasato University School of Medicine
Division name
Department of Anesthesiology
Zip code
252-0375
Address
1-15-1, Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
TEL
042-778-8606
Homepage URL
shyuga@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics committee of Kitasato University School of Medicine and Kitasato University Hospital
Address
1-15-1, Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
Tel
042-778-8606
rinri@med.kitasato-u.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
| 2022 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://webview.isho.jp/journal/detail/abs/10.18916/masui.2024020004
Publication of results
Published
Result
URL related to results and publications
https://webview.isho.jp/journal/detail/abs/10.18916/masui.2024020004
Number of participants that the trial has enrolled
417
Results
The risk factors at 2 weeks postpartum were multiparity (two or more), and admission to the intensive care unit (ICU), and the sole risk factor at 4 weeks postpartum was admission to the ICU.
Results date posted
| 2026 | Year | 01 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Women who Administered the EPDS at 2- and 4-week postpartum examinations.
Participant flow
A total of 417 postpartum women had their EPDS measured either at 2 weeks or 4 weeks postpartum. Specifically, 408 cases had their EPDS measured at 2 weeks postpartum, and 412 cases had their EPDS measured at 4 weeks postpartum.
Adverse events
None
Outcome measures
The survey items included three maternal background factors (age 35 or older, history of mental illness, no support other than husband), eight obstetric background factors (pregnancy and delivery history, gestational age less than 37 weeks, obstetric complications, multiple pregnancy, cesarean section, abnormal bleeding during delivery, anesthesia method, admission to intensive care unit), and three neonatal background factors (infant weight, admission to neonatal intensive care unit, fetal abnormalities).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To perform a retrospective review of relevant cases extracted from the medical record.
Factors associated with EPDS will be extracted and statistically analyzed.
Management information
Registered date
| 2022 | Year | 10 | Month | 31 | Day |
Last modified on
| 2026 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056221
