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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022573
Receipt No. R000023056
Scientific Title Effect of Timing of Umbilical Cord Clamping for Preventing Early infancy anemia of Term Breastfed Infants in Japan : A Randomized Controlled Trial
Date of disclosure of the study information 2016/06/01
Last modified on 2020/10/15

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Basic information
Public title Effect of Timing of Umbilical Cord Clamping for Preventing Early infancy anemia of Term Breastfed Infants in Japan
: A Randomized Controlled Trial
Acronym Effect of Timing of Umbilical Cord Clamping of Term Breastfed Infants
Scientific Title Effect of Timing of Umbilical Cord Clamping for Preventing Early infancy anemia of Term Breastfed Infants in Japan
: A Randomized Controlled Trial
Scientific Title:Acronym Effect of Timing of Umbilical Cord Clamping of Term Breastfed Infants
Region
Japan

Condition
Condition Anemia
Classification by specialty
Obsterics and gynecology Nursing Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Aim of this study is to clarify the effect of delayed cord clamping for early infancy anemia of term-breast fed infants in Japan.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Haemoglobin -SpHb- at 4 month of age
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Delayed cord clamping:
Clamp the cord after 1mins after baby was born or cord pulstations stops.
Interventions/Control_2 Early cord clamping:
Clamp the cord within 1 mins.
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

Not applicable
Age-upper limit
0 days-old >=
Gender Male and Female
Key inclusion criteria Mother and neonates who is expected term singleton vaginal delivery and willing breast feeding.
Key exclusion criteria smoking during pregnancy, maternal complications, fetal complications, emergency caesarean section, transfer to highly medical care, severe distress needs resuscitation, unable to read Japanese, impossible to return the hospital at four months of age.
Target sample size 130

Research contact person
Name of lead principal investigator
1st name Eriko
Middle name
Last name Shinohara
Organization St.Luke's International University Graduate school, Doctoral course.
Division name Nursing
Zip code 104-0044
Address 10-1 Akashicyo, Chuoku, Tokyo
TEL 03-3543-6391
Email 14DN007@sln.ac.jp

Public contact
Name of contact person
1st name Eriko
Middle name
Last name Shinohara
Organization St.Luke's International University Graduate School
Division name Midwifery
Zip code 104-0044
Address 10-1 Akashicyo, Chuoku, Tokyo
TEL 03-3543-6391
Homepage URL
Email 14DN007@slcn.ac.jp

Sponsor
Institute St.Luke's International University
Institute
Department

Funding Source
Organization Yamaji Fumiko Nursing Research Fund
Japan Academy of Midwifery's Research Fund
JSPS KAKENHI [Grant No. 26670993]
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 Institutional Review Board of St.Luke's International University
Address 10-1 Akashicyo, Chuoku, Tokyo
Tel 03-5550-2423
Email kenkyukikaku@luke.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
2016 Year 06 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 138
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason not published yet
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
2015 Year 11 Month 26 Day
Date of IRB
2015 Year 11 Month 20 Day
Anticipated trial start date
2015 Year 12 Month 05 Day
Last follow-up date
2016 Year 11 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 06 Month 01 Day
Last modified on
2020 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023056

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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