UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028947
Receipt number R000033096
Scientific Title 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
Date of disclosure of the study information 2020/01/01
Last modified on 2017/08/31 22:32:01

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Basic information

Public title

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

Acronym

Early intervention in breast milk production and effect to the milking number of times and quantity

Scientific Title

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

Scientific Title:Acronym

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

1st name
Middle name
Last name Miyuki Nishi

Organization

University of the Ryukyus Hospital

Division name

Nursing department Perinatal mother and child center

Zip code


Address

207 Uehara Nishihara town Nakagami gun Okinawa

TEL

0988953331(3410)

Email

ryudaisyuubo@outlook.jp


Public contact

Name of contact person

1st name
Middle name
Last name Sakie Miyaguni

Organization

Nursing department

Division name

Perinatal mother and child center

Zip code


Address

207 Uehara Nishihara town Nakagami gun Okinawa

TEL

0988953331(3410)

Homepage URL


Email

ryudaisyuubo@outlook.jp


Sponsor or person

Institute

University of the Ryukyus Hospital

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

2018 Year 04 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033096


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name