UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054517 |
|---|---|
| Receipt number | R000062289 |
| Scientific Title | Feasibility Study of a Breast Stimulation Program Using a Electric Breast Pump from the Day of Cesarean Section |
| Date of disclosure of the study information | 2024/08/14 |
| Last modified on | 2025/01/14 12:40:55 |
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Basic information
Public title
Feasibility Study of a Breast Stimulation Program Using a Breast Pump from the Day of Cesarean Section
Acronym
Feasibility Study of a Breast Stimulation Program Using a Breast Pump from the Day of Cesarean Section
Scientific Title
Feasibility Study of a Breast Stimulation Program Using a Electric Breast Pump from the Day of Cesarean Section
Scientific Title:Acronym
Feasibility Study of a Breast Stimulation Program Using a Breast Pump from the Day of Cesarean Section
Region
| Japan |
Condition
Condition
Breastfeeding after cesarean section
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Program Development
Feasibility of the Program: All mothers will receive nipple stimulation using an electric milking device. This will involve four stimulations within the first 24 hours after birth by cesarean section, and another four stimulations in the subsequent 24 hours. Direct breastfeeding should be used as additional stimulation.
Measurements of Programmed Milk Volume, Oxytocin Concentration, Prolactin Concentration, and Response to Primary Metabolites:
Total Amount of Breast Milk Fed in 24 Hours: This will be determined by the weight difference before and after breastfeeding and the total amount of milk expressed.
Measurement of Oxytocin and Prolactin Levels in Breast Milk and Saliva: Previous studies have shown that oxytocin concentration is affected by the measurement method and individual differences16-18). Following the procedure of a previous study18), we will assess the variation in the obtained data.
Changes in Primary Metabolites in Milk (Comparison between 3 and 5 Days Postpartum): This will help determine the changes in primary metabolites in vivo in response to the intervention.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Program feasibility (acceptability, implementation, practicality)
2) Milk volume on the third and fifth postpartum days (total 24-hour milk volume)
3) Degree of breast fullness
Key secondary outcomes
1) Oxytocin and prolactin levels (saliva and milk) at 3 and 5 days postpartum
2) Lactation status after 1 month
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
At least 4 breast stimulations in 24 hours using an electric breast pump from the day of cesarean section until the start of mother-infant rooming-in on the second day. The electric milking machine is a double pump for 15 minutes per session. Start with a pressure of 3 and adjust to a painless pressure depending on the mother.
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
1) The participants will be pregnant women who are eligible for the study if they fulfill all of the following criteria.
(1) Patients scheduled for cesarean section after 37 weeks (indications: pelvic position, placenta plevia, and cephalopelvic disproportion), (2) Patients between the ages of 20 and 43 years
(2) Between 20 and 43 years of age
(3) prefer breastfeeding
(4) Can read, write, and speak Japanese fluently
(5) who have given written consent.
Key exclusion criteria
(1) Obstetric complications (severe gestational hypertension, gestational diabetes)
(2) Non-obstetric endocrine complications (psychiatric disorders, epilepsy, heart disease, etc.)
(3) Infectious diseases transmitted from mother to child (HIV, HBV, HCV, HTLV-1)
(4) Emergency cesarean section
(5) Drug addiction, alcoholism, or smoking that affects hormones
(6) Age less than 20 years, 44 years or older
(7) Multiple pregnancy
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Ai |
| Middle name | |
| Last name | Miyauchi |
Organization
St Luke's International University Graduate school of nursing science
Division name
PhD Programs Midwifery
Zip code
104-0044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo
TEL
03-3543-6391
23dn014@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Miyauchi |
Organization
St Luke's International University Graduate school of nursing science
Division name
Doctoral Programs Midwifery
Zip code
104-0044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo
TEL
03-3543-6391
Homepage URL
23dn014@slcn.ac.jp
Sponsor or person
Institute
St Luke's International University Graduate school of nursing science
Institute
Department
Personal name
Funding Source
Organization
self-procurement
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
St Luke's International University Graduate school of nursing science
Address
10-1 Akashi-cho, Chuo-ku, Tokyo
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
| 2024 | Year | 08 | Month | 14 | 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
7
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
| 2023 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 30 | Day |
Last modified on
| 2025 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062289
