UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046774 |
|---|---|
| Receipt number | R000053072 |
| Scientific Title | Effectiveness of two weeks online postpartum check for maternal mental health |
| Date of disclosure of the study information | 2022/01/31 |
| Last modified on | 2022/01/29 06:16:30 |
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Basic information
Public title
Two weeks online postpartum check is effective for maternal mental health
Acronym
Two weeks online postpartum check is effective for maternal mental health
Scientific Title
Effectiveness of two weeks online postpartum check for maternal mental health
Scientific Title:Acronym
Effectiveness of two weeks online postpartum check for maternal mental health
Region
| Japan |
Condition
Condition
Postpartum depression
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. two weeks postpartum check (both face to face and online) for maternal mental health is effective to find and prevent postpartum depression.
2. both online and face to face postpartum check is effective.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
compare EPDS with groupA (two weeks postpartum check perfomed) and groupB (without two weeks postpartum check)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
2weeks online postpartum check
1month postpartum check
Interventions/Control_2
2weeks face to face postpartum check
1month postpartum check
Interventions/Control_3
No 2weeks postpartum check
1month postpartum check only
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
postpartum check done in same place with delivery hospital
Key exclusion criteria
no postpartum check done after delivery hospital
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Nobuko |
| Middle name | |
| Last name | Nishioka |
Organization
Koshigaya Municipal Hospital
Division name
Obstetrics and Gynecology
Zip code
343-0023
Address
10-32 HigashiKoshigaya Koshigaya City Saitama
TEL
048-965-2221
nobunsok@nifty.com
Public contact
Name of contact person
| 1st name | Nobuko |
| Middle name | |
| Last name | Nishioka |
Organization
Koshigaya Municipal Hospital
Division name
Obstetrics and Gynecology
Zip code
343-0023
Address
10-32 HigashiKoshigaya Koshigaya City Saitama
TEL
048-965-2221
Homepage URL
nobunsok@nifty.com
Sponsor or person
Institute
Obstetrics and Gynecology Koshigaya Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Koshigaya Municipal Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Saitama Medical University
Saitama Medical Center
Sakuragaoka Hospital
Jichi Medical University Saitama Medical Center
Kashiwazaki Ladies Clinic
Makita Sanfujinka
Maruyama Memorial General Hospital
Hirata Clinic
Fukaya Red Cross Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Koshigaya Municipal Hospital
Address
10-32 HigashiKoshigaya Koshigaya City Saitama
Tel
048-965-2221
nobunsok@nifty.com
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 | 01 | Month | 31 | 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 | 11 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 29 | Day |
Last modified on
| 2022 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053072
