UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063168 |
|---|---|
| Receipt number | R000072219 |
| Scientific Title | Evaluation of a Breastfeeding Program Aimed at Shortening The time Spent on Breastfeeding in Accordance with Maternal Preferences |
| Date of disclosure of the study information | 2026/10/10 |
| Last modified on | 2026/10/04 11:08:49 |
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Basic information
Public title
Evaluation of a Breastfeeding Program Aimed at Shortening The time Spent on Breastfeeding in Accordance with Maternal Preferences
Acronym
Evaluation of a Breastfeeding Program Aimed at Shortening The time Spent on Breastfeeding in Accordance with Maternal Preferences
Scientific Title
Evaluation of a Breastfeeding Program Aimed at Shortening The time Spent on Breastfeeding in Accordance with Maternal Preferences
Scientific Title:Acronym
Evaluation of a Breastfeeding Program Aimed at Shortening The time Spent on Breastfeeding in Accordance with Maternal Preferences
Region
| Japan |
Condition
Condition
Postpartum women
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to evaluate a breastfeeding support program designed to shorten the time spent on breastfeeding, in accordance with the preferences of mothers in the early postpartum period.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time spent on breastfeeding
Key secondary outcomes
Fatigue, Sleep satisfaction, Sleep duration, Depression, Bonding, Breastfeeding Self-efficacy, Satisfaction with breastfeeding guidance, Breast milk volume, Frequency of direct breastfeeding, Nipple and areola problems, Latch-on status, Nipple shield usage rate, Difficult baby
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Training for midwives on a breastfeeding support program developed by researchers and Provision of care to mothers by midwives trained in a breastfeeding support program.
Interventions/Control_2
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Midwives and postpartum mothers who are breastfeeding during their hospital stay at a regional perinatal maternal and child medical center.
Key exclusion criteria
Excluding individuals under the age of 18, those unable to read or write Japanese, those with severe maternal or neonatal complications, those undergoing treatment for mental illness, and mothers who received breastfeeding support from midwives not participating in the study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ayako |
| Middle name | |
| Last name | Sakaid |
Organization
Japanese Red Cross Toyota College of Nursing
Division name
Graduate school
Zip code
471-8565
Address
12-33 Nanamagari, Hakusan-cho, Toyota, Aichi,
TEL
0565-36-5111
rct228001@rctoyota.ac.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Sakaid |
Organization
Japanese Red Cross Toyota College of Nursing
Division name
Graduate school
Zip code
471-8565
Address
12-33 Nanamagari, Hakusan-cho, Toyota, Aichi,
TEL
0565-36-5111
Homepage URL
rct228001@rctoyota.ac.jp
Sponsor or person
Institute
Japanese Red Cross Toyota College of Nursing
Institute
Department
Personal name
Funding Source
Organization
Japanese Red Cross Toyota College of Nursing
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
Secretariat of the Research Ethics Review Committee, Japanese Red Cross Toyota College of Nursing
Address
12-33 Nanamagari, Hakusan-cho, Toyota, Aichi,
Tel
0565-36-5111
kenkyu-rinri@rctoyota.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
刈谷豊田総合病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 08 | 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
| 2026 | Year | 10 | Month | 04 | Day |
Last modified on
| 2026 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072219
