UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049467 |
|---|---|
| Receipt number | R000056325 |
| Scientific Title | Verification of the effect of breast massage care on breast engorgement |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2022/11/09 14:19:00 |
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Basic information
Public title
Verification of the effect of breast massage care on breast engorgement
Acronym
Verification of the effect of breast massage care on breast engorgement
Scientific Title
Verification of the effect of breast massage care on breast engorgement
Scientific Title:Acronym
Verification of the effect of breast massage care on breast engorgement
Region
| Japan |
Condition
Condition
Women who have a normal pregnancy and delivery process for both mother and child and wish to breastfeed.
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The course of breast engorgement symptoms that appeared in the early postpartum period will be clarified in relation to changes in udder findings and intramammary blood flow.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Axillary, lateral thoracic, and medial thoracic arteriovenous blood flow
(around 36 weeks gestation, 1st, 3rd, and 5th days postpartum)
Evaluate twice on the third postpartum day only: before breast massage and after massage and breastfeeding.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Planned vaginal delivery of a single fetus
Key exclusion criteria
Women with psychiatric complications, abnormal glucose metabolism, cardiac disease, history of hypertension, and history of breast disease and its surgery
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yumiko |
| Middle name | |
| Last name | Tateoka |
Organization
Shiga University of Medical Science
Division name
Course of Nursing
Zip code
5202144
Address
Seta Tsukinawa-cho, Otsu City, Shiga
TEL
0775482111
ytateoka@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | |
| Last name | Tateoka |
Organization
Shiga University of Medical Science
Division name
Course of Nursing
Zip code
5202144
Address
Seta Tsukinawa-cho, Otsu City, Shiga
TEL
0775482111
Homepage URL
ytateoka@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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
Shiga University of Medical Science
Address
Seta Tsukinawa-cho, Otsu City, Shiga
Tel
0775482111
ytateoka@belle.shiga-med.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
| 2023 | Year | 01 | 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
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
| 2022 | Year | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 11 | Month | 09 | Day |
Last modified on
| 2022 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056325
