UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055023 |
|---|---|
| Receipt number | R000062858 |
| Scientific Title | Risk Factors of postpartum depression for maternal mental health care |
| Date of disclosure of the study information | 2024/07/22 |
| Last modified on | 2024/07/19 12:24:40 |
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Basic information
Public title
Risk Factors of postpartum depression for maternal mental health care
Acronym
Risk Factors of postpartum depression
Scientific Title
Risk Factors of postpartum depression for maternal mental health care
Scientific Title:Acronym
Risk Factors of postpartum depression
Region
| Japan |
Condition
Condition
Postpartum Depression
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Postpartum depression affects 5-10% of mothers in Japan. This study aimed to use the Edinburgh Postnatal Depression Scale to determine the mental status of mothers, screen them for postpartum depression, and examine associated risk factors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The risk factor item where Edinburgh Postnatal Depression Scale becomes positive
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
This study will include mothers who are delivered their babies at our hospital and be screened using the EPDS at the 1-month postpartum checkup.
Key exclusion criteria
The pregnant woman who did not perform to delivery at our hospital
The pregnant woman who was delivered at our hospital, but did not receive examination for one month in after giving birth
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Miyoko |
| Middle name | |
| Last name | Waratani |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
602-8566
Address
645 Kaijii-cho, Kamigyo-ku, Kyoto-shi, Kyoto
TEL
075-251-5111
mwara@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Miyoko |
| Middle name | |
| Last name | Waratani |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
602-8566
Address
645 Kaijii-cho, Kamigyo-ku, Kyoto-shi, Kyoto
TEL
075-251-5111
Homepage URL
mwara@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
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
Kyoto Prefectural University of Medicine
Address
645 Kaijii-cho, Kamigyo-ku, Kyoto-shi, Kyoto
Tel
075-251-5111
mwara@koto.kpu-m.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
| 2024 | Year | 07 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
There is no related information.
Management information
Registered date
| 2024 | Year | 07 | Month | 19 | Day |
Last modified on
| 2024 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062858
