Immediate VS Delayed Cord Clamping on Newborns
Effect of Umbilical Cord Clamping Time on Newborns
1 other identifier
interventional
120
1 country
1
Brief Summary
The best time of the umbilical cord clamping has not been fully understood. immediate cord clamping (with in 10 seconds after birth) has been standardized practice for many years, while WHO protocol recommends to wait for 60-90 seconds. but the umbilical cord may still pulse for more than 90 seconds. is it best to wait longer until the pulsing ceased? how the time of umbilical cord will affect the newborn? will the longer time be less umbilical bleeding and shorter departure time of the cord? the hypothesis of this study is: to cut the cord after the pulsing ceased is the best time for cord clamping and will result in better quality of life for the newborn and less cord bleeding and earlier departure time of the cord, that means less infections of the cord.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 9, 2009
CompletedFirst Posted
Study publicly available on registry
December 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedMarch 2, 2010
September 1, 2009
1 year
December 9, 2009
March 1, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
hemoglobin level of the baby 1 month after birth
2 years
Secondary Outcomes (1)
departure time of the umbilical cord
2 years
Interventions
1. for normal birth(apgar score over 7),include:term ,preterm,normal birth or cesarean section : experimental group1: waiting until the ceased of the umbilical cord pulsing, then cut the cord.before cutting the cord, the baby is keeping warm and put over mother's abdomen. control group 1-1: clamping and cut the cord within 10 second after birth. control group1-2: clamping and cut the cord 90 second after birth. 2. for in case of asphyxia(regardless term or preterm,normal birth or cesarean section born): experimental group2: resuscitate on bed site with the cord unclamped until the umbilical cord ceased pulsing. control group 2-1 clamping and cut the cord within 10 second. and resuscitate the baby after transfer to the Irradiation table.
Eligibility Criteria
You may qualify if:
- all living baby after birth, including term, preterm, normal birth, cesarean section, apgar score over 7 or less than that.
You may not qualify if:
- still birth
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hainan Medical College Appendix Hospital
Haikou, Hainan, 571101, China
Related Publications (1)
zhang hong-yu,Meng li-ping,Xie chun-li.summary of current clinical protocols of umbilical cord care.Chinese journal of nurisng.3(43):275-277,2008
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
hua shao ping, professor
director of ob&gny dpt.of appendix hospital of hainan medical college
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 9, 2009
First Posted
December 10, 2009
Study Start
September 1, 2009
Primary Completion
September 1, 2010
Study Completion
June 1, 2011
Last Updated
March 2, 2010
Record last verified: 2009-09