UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055824 |
|---|---|
| Receipt number | R000063806 |
| Scientific Title | Increasing Lactogenesis II Program Using a Breast Pump Shortly after Cesarean section: A Quasi-Experimental Research. |
| Date of disclosure of the study information | 2025/01/31 |
| Last modified on | 2025/10/19 10:32:16 |
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Basic information
Public title
Increasing Lactogenesis II Program Using a Breast Pump
Shortly after Cesarean section: A Quasi-Experimental Research.
Acronym
Increasing Lactogenesis II Program Using a Breast Pump
Shortly after Cesarean section: A Quasi-Experimental Research.
Scientific Title
Increasing Lactogenesis II Program Using a Breast Pump
Shortly after Cesarean section: A Quasi-Experimental Research.
Scientific Title:Acronym
Increasing Lactogenesis II Program Using a Breast Pump
Shortly after Cesarean section: A Quasi-Experimental Research.
Region
| Japan |
Condition
Condition
Breastfeeding after cesarean section
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effectiveness of an intervention that promotes milk production through physiological mechanisms by stimulating the nipple with a breast pump at least four times within 24 hours, starting on the day of cesarean delivery, for mothers who wish to breastfeed after cesarean delivery. This will be compared to a control group receiving usual care. The study aims to examine the effectiveness of methods to support the continuation of breastfeeding.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The time from delivery to the onset of lactgenesis II in the intervention group is significantly shorter than that in the control group.
Key secondary outcomes
(1) 24-hour breast milk volume on days 3 and 5 is significantly higher in the intervention group than in the control group.
(2) The intervention group has a significantly higher rate of breastfeeding at 1 month compared to the control group.
(3) Oxytocin and prolactin levels are less inclined to fall from day 3 to day 5 postpartum in the intervention group than in the control group.
(4) Awareness of colostrum feeding and breastfeeding satisfaction is higher in the intervention group.
(5) Knowledge of breastfeeding is significantly higher in the intervention group.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Provision of information on general knowledge of breastfeeding and nipple stimulation with a breast pumps at least four times in 24 hours from the day of caesarean section.
Interventions/Control_2
Provision of information on breastfeeding after caesarean section.
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
Eligibility criteria: Healthy postpartum women aged 20 to 43 who want to breastfeed after a cesarean section at 37 weeks or later (including planned cesarean sections and emergency cesarean sections)
Key exclusion criteria
(1) Vaginal delivery
(2) Premature birth
(3) Multiple pregnancy
(4) Complications (psychiatric disorders, epilepsy, heart disease, etc.)
(5) Infectious diseases that can be transmitted from mother to child (HIV, HBV, HCV, HTLV-1)
(6) Drug dependence, alcoholism or smoking that affects hormones
(7) Under 20 years old or over 44 years old
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Ai |
| Middle name | |
| Last name | Miyauchi |
Organization
National Center for Child Health and Development
Division name
Department of Sociomedical Research
Zip code
1570074
Address
2 Chome-10 Okura, Setagaya City, Tokyo
TEL
003-3416-0181
miyauchi-a@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Miyauchi |
Organization
St. Luke's International University Graduate School
Division name
St. Luke's International University Graduate School of Nursing Science
Zip code
1040045
Address
Tokyo Chuo City Tsukiji 3-8-5
TEL
03-3543-6391
Homepage URL
23dn014@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University Graduate School of Nursing Science
Ai Miyauchi
Institute
Department
Personal name
Ai Miyauchi
Funding Source
Organization
JSPS KAKENHI Grant
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
St. Luke's International University Graduate School of Nursing Science
Address
Tokyo Chuo City Tsukiji 3-8-5
Tel
03-3543-6391
23dn014@slcn.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
| 2025 | Year | 01 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 10 | 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
| 2024 | Year | 10 | Month | 13 | Day |
Last modified on
| 2025 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063806
