UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024728 |
|---|---|
| Receipt number | R000028452 |
| Scientific Title | The influence of the change in breasts on continual breast milk expression by Ashiyu, on puerperants under the condition of mother-infant separation |
| Date of disclosure of the study information | 2016/11/07 |
| Last modified on | 2022/12/21 19:12:38 |
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Basic information
Public title
The influence of the change in breasts on continual breast milk expression by Ashiyu, on puerperants under the condition of mother-infant separation
Acronym
The influence of the change in breasts on continual breast milk expression by Ashiyu, on puerperants under the condition of mother-infant separation
Scientific Title
The influence of the change in breasts on continual breast milk expression by Ashiyu, on puerperants under the condition of mother-infant separation
Scientific Title:Acronym
The influence of the change in breasts on continual breast milk expression by Ashiyu, on puerperants under the condition of mother-infant separation
Region
| Japan |
Condition
Condition
Puerperants under the condition of mother-infant separation
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Focusing on the early puerperium,
changes in state of nipple, areola and breasts by Ashiyu on puerperants under the condition of mother-infant separation will be evaluated both quantitatively with observation and palpation and qualitatively with measurement devices.
The influence of the changes in state of the nipple, areola and breasts on the ease of milk expression will be elucidated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
skin viscoelasticity
Key secondary outcomes
breast skin temperature, skin strain, skin hardness, total amount of daily breast milking,forms of nipples and areolas
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Experimental group:Ashiyu, a guidance on milking
Interventions/Control_2
Control group:a guidance on milking
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
| Not applicable |
Gender
Female
Key inclusion criteria
Puerperants with more than 24 weeks of pregnancy, who gave birth to a baby of 1,500g or more, having the baby hospitalized in NICU/GCU, hoping to breast-feed, needs expression of milk by necessity on the early puerperium.
Key exclusion criteria
Puerperants who had a caesarean section,Puerperants who is suffering from complications,Puerperants who has HTLV-1,Puerperants who can breast-feed,Puerperants with less than 24 weeks of pregnancy, Puerperants who gave birth to an infant with very low birth weight,Puerperants who gave birth to multiples,
Puerperants who has a high risk child,Puerperants who can comprehend written Japanese,Puerperants who was under 20 years of age when participated in the research.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tokuko |
| Middle name | |
| Last name | Kojima |
Organization
Aichi Medical University
Division name
College of Nursing
Zip code
480-1195
Address
1-1,Karimata,Yazako,Nagakute-shi,Aichi,Japan
TEL
0561-62-3311
kojima.tokuko.755@mail.aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Tokuko |
| Middle name | |
| Last name | Kojima |
Organization
Aichi Medical University
Division name
College of Nursing
Zip code
480-1195
Address
1-1,Karimata,Yazako,Nagakute-shi,Aichi,Japan
TEL
0561-62-3311
Homepage URL
kojima.tokuko.755@mail.aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Medical University Hospital Ethics Committee
Address
1-1,Karimata,Yazako,Nagakute-shi,Aichi,Japan
Tel
0561-62-3311
kanrika@aichi-med-u.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
愛知医科大学病院（愛知県） Aichi Medical University Hospital（Aichi）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 07 | Day |
Related information
URL releasing protocol
https://aichi-pu.repo.nii.ac.jp/?action=pages_view_main&active_action=repository_view_main_item_deta
Publication of results
Published
Result
URL related to results and publications
https://aichi-pu.repo.nii.ac.jp/?action=pages_view_main&active_action=repository_view_main_item_deta
Number of participants that the trial has enrolled
30
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
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 05 | 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
| 2016 | Year | 11 | Month | 06 | Day |
Last modified on
| 2022 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028452
| 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 |
