UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022573 |
|---|---|
| Receipt number | 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 17:22:30 |
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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
| Obstetrics 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
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
14DN007@slcn.ac.jp
Sponsor or person
Institute
St.Luke's International University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023056
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
