UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062470 |
|---|---|
| Receipt number | R000071341 |
| Scientific Title | Implementation of a Gentle Nipple Stimulation Program Using a Breast Pump shortly After Delivery |
| Date of disclosure of the study information | 2026/08/04 |
| Last modified on | 2026/08/04 19:25:24 |
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Basic information
Public title
Implementation of a Gentle Nipple Stimulation Program Using a Breast Pump shortly After Delivery
Acronym
Gentle Nipple Stimulation Program
Scientific Title
Implementation of a Gentle Nipple Stimulation Program Using a Breast Pump shortly After Delivery
Scientific Title:Acronym
Gentle Nipple Stimulation Program
Region
| Japan |
Condition
Condition
Mothers of infants who have difficulty breastfeeding frequently following a cesarean section or a epidural anethtesia delivery
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
If a mother is unable to breastfeed sufficiently on the day of delivery following a cesarean section or an epidural, milk production may be delayed. In this study, we will evaluate the feasibility of implementing a program in clinical settings that involves gentle nipple stimulation using a breast pump shortly after delivery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
Acceptability, Appropriateness, Feasibility, and Sustainability
Key secondary outcomes
Time to onset of lactogenesis 2, Breast milk volume on postpartum day 5
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
In this study, we will implement a program in clinical settings that involves gentle nipple stimulation using a breast pump shortly after delivery, and evaluate its implementability.
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
| 20 | years-old | <= |
Age-upper limit
| 43 | years-old | >= |
Gender
Female
Key inclusion criteria
mothers
1) Mothers who undergo a cesarean section (scheduled or emergency) at 37 weeks or later at a participating facility
2) Mothers whose breastfeeding is delayed on the day of delivery due to neonatal factors (such as early vomiting, week sucking, or hypoglycemia), even after an anesthetized delivery
3) Mother-infant pairs for whom direct breastfeeding is not scheduled from the day of delivery until the following morning due to reasons related to the mother
4) Mothers of preterm infants or those requiring medical treatment, resulting in a period of separation between mother and infant
5) Prefer to breastfeed
6) Aged 20 years or older but under 44 years at the time consent is obtained.
7) Participants for whom written informed consent has been obtained regarding participation in this study
Midwives
none
Key exclusion criteria
1) Individuals whose ability to breastfeed is limited due to a pre-existing condition or complications
2) Individuals whose newborn has a serious medical condition
3) Other individuals deemed unsuitable by the principal investigator (or co-investigator). (e.g., severe fatigue)
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Ai |
| Middle name | |
| Last name | Miyauchi |
Organization
St Luke's International University
Division name
women's health and midwifery
Zip code
104-8560
Address
10-1 Akashicho Chuoku, Tokyo
TEL
03-5550-7065
miyauchi.ai.hm@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Miyauchi |
Organization
St Luke's International University
Division name
women's health and midwifery
Zip code
104-8560
Address
10-1 Akashicho Chuoku, Tokyo
TEL
03-5550-7065
Homepage URL
miyauchi.ai.hm@slcn.ac.jp
Sponsor or person
Institute
St Luke's International University
Institute
Department
Personal name
Funding Source
Organization
none
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
St Luke's International University
Address
10-1 Akashicho Chuoku, Tokyo
Tel
03-5550-7065
kenkyukikaku@luke.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
聖路加国際病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 04 | 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
| 2026 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | 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 | 08 | Month | 04 | Day |
Last modified on
| 2026 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071341
