UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Early intervention in breast milk production of mothers who gave birth to protein infants and their effect to the milking number of times and quantity
Title of the study (Brief title)	Early intervention in breast milk production and effect to the milking number of times and quantity
Region	Japan

Condition
Condition	breast milk production
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	consider the effect of early intervention program on breast milk production on increase and maintenance of milking volume
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	breast milk volume can be increased and maintained in 1 month after birth from commencement of breast milk production early postpartum
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	early postpartum breast milk production. pregnant women 22weeks-33weeks. The first time within 2-3hours after birth, the next time within 6 hours after birth. Breastfeeding care is carried out 8 times a day or more.Do papilla care by hand,stimulate milking in a milking machine.
Interventions/Control_2	Evaluation of the number of milking and amount during hospital stay,1 week after discharge and 1 month after birth.
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	22 weeks-old <=
Age-upper limit	33 weeks-old >=
Gender	Female
Key inclusion criteria	Twin pregnant women,mental psychiatric pregnant women other than pregnant women.
Key exclusion criteria	Twin pregnant women,mental psychiatric pregnant women.
Target sample size	100

Research contact person
Name of lead principal investigator	Miyuki Nishi
Organization	University of the Ryukyus Hospital
Division name	Nursing department Perinatal mother and child center
Address	207 Uehara Nishihara town Nakagami gun Okinawa
TEL	0988953331(3410)
Email	ryudaisyuubo@outlook.jp

Public contact
Name of contact person	Sakie Miyaguni
Organization	Nursing department
Division name	Perinatal mother and child center
Address	207 Uehara Nishihara town Nakagami gun Okinawa
TEL	0988953331(3410)
Homepage URL
Email	ryudaisyuubo@outlook.jp

Sponsor
Institute	University of the Ryukyus Hospital
Institute
Department

Funding Source
Organization	University of the Ryukyus Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	琉球大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 04 Month 01 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 31 Day
Last modified on	2017 Year 08 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033096