UMIN-CTR Clinical Trial

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
Email	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
Email	ytateoka@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056325