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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024728
Receipt No. 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 2016/11/06

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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
Middle name
Last name Tokuko Kojima
Organization Aichi Medical University
Division name College of Nursing
Zip code
Address 1-1,Karimata,Yazako,Nagakute-shi,Aichi,Japan
TEL 0561-62-3311
Email kojima.tokuko.755@mail.aichi-med-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tokuko Kojima
Organization Aichi Medical University
Division name College of Nursing
Zip code
Address 1-1,Karimata,Yazako,Nagakute-shi,Aichi,Japan
TEL 0561-62-3311
Homepage URL
Email kojima.tokuko.755@mail.aichi-med-u.ac.jp

Sponsor
Institute Aichi Medical University
Institute
Department

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
Address
Tel
Email

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
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
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 07 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
2016 Year 11 Month 06 Day
Last modified on
2016 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028452

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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