UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003517 |
|---|---|
| Receipt number | R000004267 |
| Scientific Title | Development and evaluation of a self care program on breastfeeding in Japan: A quasi-experimental study |
| Date of disclosure of the study information | 2010/04/22 |
| Last modified on | 2010/04/23 21:44:39 |
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Basic information
Public title
Development and evaluation of a self care program on breastfeeding in Japan: A quasi-experimental study
Acronym
Development and evaluation of breastfeeding self care program
Scientific Title
Development and evaluation of a self care program on breastfeeding in Japan: A quasi-experimental study
Scientific Title:Acronym
Development and evaluation of breastfeeding self care program
Region
| Japan |
Condition
Condition
breastfeeding
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to develop a self care program for breastfeeding that increased mothers breastfeeding confidence and to evaluate its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
breastfeeding self efficacy and breastfeeding rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
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
breastfeeding self care program
Interventions/Control_2
standard breastfeeding care
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
| 38 | years-old | >= |
Gender
Female
Key inclusion criteria
planning on breastfeeding and healthy during the pregnancy through postpartum period; delivered a healthy term singleton infant, birth weight of baby is over 2500g
Key exclusion criteria
acute or chronic disease; taking medication; did not have a home dvd player and those who were not planning a one month check up at the same hospital where they gave birth
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayo Awano |
Organization
Graduate Course of Nursing Science Kanazawa University
Division name
Department of Health Development Nursing
Zip code
Address
13-1 Kodatsuno Kanazawa City Ishikawa, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate Course of Nursing Science Kanazawa University
Division name
Department of Health Development Nursing
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Kanazawa University Graduate Course of Nursing Science
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University
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
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | 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
Completed
Date of protocol fixation
| 2007 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 21 | Day |
Last modified on
| 2010 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004267
