UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054751 |
|---|---|
| Receipt number | R000062568 |
| Scientific Title | Breastfeeding support during the first month postpartum using a deep learning based nipple damage assessment system effects on the breastfeeding experience. |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2025/03/27 14:24:01 |
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Basic information
Public title
Breastfeeding support during the first month postpartum using a deep learning based nipple damage assessment system
effects on the breastfeeding experience.
Acronym
Breastfeeding support during the first month postpartum using a deep learning based nipple damage assessment system
effects on the breastfeeding experience.
Scientific Title
Breastfeeding support during the first month postpartum using a deep learning based nipple damage assessment system
effects on the breastfeeding experience.
Scientific Title:Acronym
Breastfeeding support during the first month postpartum using a deep learning based nipple damage assessment system
effects on the breastfeeding experience.
Region
| Japan |
Condition
Condition
nipple injury
Classification by specialty
| Obstetrics and Gynecology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of breastfeeding support in the first month postpartum on the breastfeeding experience, using a system developed by the applicants, which uses deep learning to determine the severity of nipple damage (see below).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Lactation-related information during hospitalisation (method of feeding, frequency of feeding, nipple pain score), Japanese Breastfeeding Self-Efficacy Scale (BSES-SF), Revised Breastfeeding Rating Scale (JMBFES)
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
In addition to the usual care received at the facility, such as breastfeeding support and newborn visits, the intervention group submits images of the breast area taken with a research-specific smartphone that is not set up to connect to the internet (hereafter, research smartphone) on one occasion during the delivery hospitalisation. The submitted images are analysed using deep learning and the research subjects receive materials according to the results of the decision.
Interventions/Control_2
The control group receives only usual 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
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Longitudinal study of approximately 200 Japanese women aged 18 years and over, from late pregnancy to one month postpartum.
Key exclusion criteria
Not eligible if direct breastfeeding of the newborn is not confirmed (e.g. internal feeding due to mental illness, risk of mother-to-child infection, expected long-term separation of mother and child) or if the general operation of the smartphone is difficult.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Ebina |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Department of Midwifery, Maternity Nursing and Women's Health
Zip code
060-0812
Address
Kita 12,Nishi 5, Kita-ku, Sapporo
TEL
011-706-2822
ebiyas@hs.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Maya |
| Middle name | |
| Last name | Nakamura |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Department of Midwifery, Maternity Nursing and Women's Health
Zip code
060-0812
Address
Kita 12,Nishi 5, Kita-ku, Sapporo
TEL
011-706-2822
Homepage URL
ebiyas@hs.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Yasuhiko Ebina
Funding Source
Organization
Hokkaido 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
Faculty of Health Sciences, Hokkaido University
Address
Kita 12,Nishi 5, Kita-ku, Sapporo
Tel
011-706-3338
shomu@hs.hokudai.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | 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
23
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
| 2024 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 25 | Day |
Last modified on
| 2025 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062568
