UMIN-CTR Clinical Trial

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