UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028947 |
|---|---|
| Receipt number | R000033096 |
| Scientific Title | Early intervention in breast milk production of mothers who gave birth to protein infants and their effect to the milking number of times and quantity |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2017/08/31 22:32:01 |
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Basic information
Public title
Early intervention in breast milk production of mothers who gave birth to protein infants and their effect to the milking number of times and quantity
Acronym
Early intervention in breast milk production and effect to the milking number of times and quantity
Scientific Title
Early intervention in breast milk production of mothers who gave birth to protein infants and their effect to the milking number of times and quantity
Scientific Title:Acronym
Early intervention in breast milk production and effect to the milking number of times and quantity
Region
| Japan |
Condition
Condition
breast milk production
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
consider the effect of early intervention program on breast milk production on increase and maintenance of milking volume
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
breast milk volume can be increased and maintained in 1 month after birth from commencement of breast milk production early postpartum
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-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
| Maneuver |
Interventions/Control_1
early postpartum breast milk production.
pregnant women 22weeks-33weeks.
The first time within 2-3hours after birth, the next time within 6 hours after birth.
Breastfeeding care is carried out 8 times a day or more.Do papilla care by hand,stimulate milking in a milking machine.
Interventions/Control_2
Evaluation of the number of milking and amount during hospital stay,1 week after discharge and 1 month after birth.
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
| 22 | weeks-old | <= |
Age-upper limit
| 33 | weeks-old | >= |
Gender
Female
Key inclusion criteria
Twin pregnant women,mental psychiatric pregnant women other than pregnant women.
Key exclusion criteria
Twin pregnant women,mental psychiatric pregnant women.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miyuki Nishi |
Organization
University of the Ryukyus Hospital
Division name
Nursing department Perinatal mother and child center
Zip code
Address
207 Uehara Nishihara town Nakagami gun Okinawa
TEL
0988953331(3410)
ryudaisyuubo@outlook.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sakie Miyaguni |
Organization
Nursing department
Division name
Perinatal mother and child center
Zip code
Address
207 Uehara Nishihara town Nakagami gun Okinawa
TEL
0988953331(3410)
Homepage URL
ryudaisyuubo@outlook.jp
Sponsor or person
Institute
University of the Ryukyus Hospital
Institute
Department
Personal name
Funding Source
Organization
University of the Ryukyus Hospital
Organization
Division
Category of Funding Organization
Other
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
琉球大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 01 | 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
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | 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
| 2017 | Year | 08 | Month | 31 | Day |
Last modified on
| 2017 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033096
