UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007449 |
|---|---|
| Receipt number | R000008749 |
| Scientific Title | A Randomized Control Study to Investigate the Effectiveness of Infant Immunization Education in the Perinatal Period |
| Date of disclosure of the study information | 2012/03/05 |
| Last modified on | 2014/01/14 06:54:27 |
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Basic information
Public title
A Randomized Control Study to Investigate the Effectiveness of Infant Immunization Education
in the Perinatal Period
Acronym
Investigation of the Effectiveness of Infant Immunization Education
Scientific Title
A Randomized Control Study to Investigate the Effectiveness of Infant Immunization Education
in the Perinatal Period
Scientific Title:Acronym
Investigation of the Effectiveness of Infant Immunization Education
Region
| Japan |
Condition
Condition
women during perinatal period
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purposes of this study are (i) to verify the effect of early educational intervention in perinatal settings and (ii) to investigate when the most effective period of initial immunization education is during the perinatal period in Japan
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
An immunization up-to-date status when the infant was at three months of age for Hib vaccine, PCV7, and HBV vaccine
Key secondary outcomes
A change in maternal knowledge, attitudes and beliefs and intention to receive immunization between the pre-study evaluation and post-study evaluation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Pregnant women at GA 34-36 weeks who visited pregnancy check-up and received individual immunization education for 5-10 min.
Interventions/Control_2
Postpartum women within one week after birth who received individual immunization education for 5-10 min.
Interventions/Control_3
Control
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Pregnant women who were 18 years or older during the investigation period
Key exclusion criteria
i) Mother who have cognitive inpairment
ii) Mother who suffers physical or mental burden by the investigation
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sachiyo Murasima |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Division of Health Sciences and Nursing
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
TEL
03-5841-3597
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aya Saito |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Division of Health Sciences and Nursing
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
TEL
03-5841-3597
Homepage URL
aya-saitoh@umin.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
National Center for Child Health and Development
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
Address
Tel
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
国立成育医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Saitoh A, Nagata S, et al. Perinatal Immunization Education Improves Immunization Rates and Knowledge: A randomized controlled trial. Preventive Medicine 2013; 56(6): 398-405
This was presented in part at the 50th Annual Meeting of Infectious Diseases
Society of America, San Diego, CA, October, 2012.
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
Completed
Date of protocol fixation
| 2011 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 05 | Day |
Last modified on
| 2014 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008749
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
