UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052807 |
|---|---|
| Receipt number | R000060251 |
| Scientific Title | Infant injury prevention starting from pregnancy: Development of a push-based delivery of education program using community resources |
| Date of disclosure of the study information | 2023/11/20 |
| Last modified on | 2024/05/20 13:44:36 |
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Basic information
Public title
Infant injury prevention starting from pregnancy: Development of a push-based delivery of education program using community resources
Acronym
Infant injury prevention starting from pregnancy
Scientific Title
Infant injury prevention starting from pregnancy: Development of a push-based delivery of education program using community resources
Scientific Title:Acronym
Infant injury prevention starting from pregnancy
Region
| Japan |
Condition
Condition
Infant Injury
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of push delivery of educational videos on injury prevention to pregnant women on (1) knowledge of injury prevention and intention to implement preventive behaviors in the late pregnancy, (2) implementation of injury prevention behaviors two months postpartum, and (3) occurrence of accidental injuries one year postpartum.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intention to implement injury prevention behaviors in late pregnancy
Key secondary outcomes
(1) knowledge of injury prevention in the late pregnancy, (2) implementation of injury prevention behaviors two months postpartum, and (3) occurrence of accidental injuries one year postpartum.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Electronic distribution of infant injury prevention videos via a push-type system
Interventions/Control_2
Electronic distribution of conventional leaflets on injury prevention and leaflets on how to spend the pregnancy period (diet, disaster prevention, etc.)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Pregnant women between 20-32 weeks' gestation who are registered with the Maternal and Child Health Handbook application of the municipality in which the study is conducted or who participated in the antenatal classes. The pregnant women must be able to answer the questionnaire in Japanese.
Key exclusion criteria
Those who do not meet the inclusion criteria
Target sample size
258
Research contact person
Name of lead principal investigator
| 1st name | Chikako |
| Middle name | |
| Last name | Honda |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
1130033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3597
hchika-tky@g.ecc.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Chikako |
| Middle name | |
| Last name | Honda |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
1130033
Address
Hongo7-3-1 Bunkyo-ku, Tokyo, Japan
TEL
03-5841-3597
Homepage URL
hchika-tky@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo, Clinical Research Review Board
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2023 | Year | 11 | Month | 20 | 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
| 2023 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 15 | Day |
Last modified on
| 2024 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060251
