UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061026 |
|---|---|
| Receipt number | R000069026 |
| Scientific Title | Development of Educational Materials for Training Healthcare Professionals in Birth Review Practice During the Perinatal Period |
| Date of disclosure of the study information | 2026/03/23 |
| Last modified on | 2026/03/23 21:42:20 |
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Basic information
Public title
Development of Educational Materials for Training Healthcare Professionals in Birth Review Practice During the Perinatal Period
Acronym
Birth Review Education
Scientific Title
Development of Educational Materials for Training Healthcare Professionals in Birth Review Practice During the Perinatal Period
Scientific Title:Acronym
Birth Review Education
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop an educational program for midwives and midwifery students to support the appropriate implementation of birth review and to evaluate its effectiveness and feasibility in clinical practice.
Basic objectives2
Others
Basic objectives -Others
Educational intervention study to evaluate effectiveness and feasibility
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Self-efficacy related to conducting birth review will be assessed at baseline, immediately after the intervention period (up to 1 week after allocation), and 1 month after baseline.
The primary outcome is the change in self-efficacy from baseline to 1 month after baseline.
Key secondary outcomes
Changes in attitudes toward birth review and knowledge regarding birth review will be assessed at baseline, immediately after the intervention period (up to 1 week after allocation), and 1 month after baseline.
Intention to implement birth review within 3 months will be assessed immediately after the intervention period and 1 month after baseline in the intervention group only.
Feasibility and acceptability of the educational program will be assessed immediately after the intervention period and 1 month after baseline in the intervention group only.
Qualitative feedback related to the implementation of birth review will be assessed immediately after the intervention period and 1 month after baseline in both groups.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants in the intervention group will receive a video-based educational program developed to support the appropriate implementation of birth review. After allocation, participants will be instructed to view the assigned video within 1 week. The program is intended to be viewed once; however, repeated viewing within the intervention period will be allowed to facilitate understanding.
Interventions/Control_2
Participants in the control group will be assigned to a waiting-list condition. During the 1-week intervention period after allocation, no educational video will be provided, and participants will complete assessments at corresponding time points. After completion of the 1-month follow-up assessment, they will be offered the same video-based educational program as the intervention group.
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
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
Participants who meet all of the following criteria will be included:
1.Midwives involved in perinatal care or students enrolled in a midwifery training program
2.Able to view the educational video on birth review
3.Aged 20 years or older at the time of consent
4.Provided informed consent electronically (Employment setting or workplace will not be restricted)
Key exclusion criteria
Participants meeting any of the following criteria will be excluded:
1.Self-reported difficulty in viewing the educational material or completing the online questionnaire
2.Difficulty understanding Japanese or responding to the questionnaire
3.Self-reported high risk of psychological burden associated with participation
4.Considered inappropriate for participation by the principal investigator
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Baba |
Organization
St. Luke's International University
Division name
Graduate School of Nursing Science
Zip code
1040044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo, Japan
TEL
0335436391
baba.kaori.f4@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Baba |
Organization
St. Luke's International University
Division name
Graduate School of Nursing Science
Zip code
1040044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo, Japan
TEL
0335436391
Homepage URL
baba.kaori.f4@slcn.ac.jp
Sponsor or person
Institute
St. Luke's Internatilnal University
Institute
Department
Personal name
Kaori Baba
Funding Source
Organization
St. Luke's International University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, St. Luke's International University
Address
Akashi-cho, Chuo-ku, Tokyo, Japan
Tel
033543-6391
kenkyukikaku@luke.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
東京都
Institutions
Institutions
聖路加国際大学
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 10 | Day |
Date of closure to data entry
| 2026 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 23 | Day |
Last modified on
| 2026 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069026
