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Immediate VS Delayed Cord Clamping on Newborns (no)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Hainan Medical College.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hainan Medical College
ClinicalTrials.gov Identifier:
NCT01029496
First received: December 9, 2009
Last updated: March 1, 2010
Last verified: September 2009

December 9, 2009
March 1, 2010
September 2009
September 2010   (final data collection date for primary outcome measure)
hemoglobin level of the baby 1 month after birth [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01029496 on ClinicalTrials.gov Archive Site
departure time of the umbilical cord [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Immediate VS Delayed Cord Clamping on Newborns
Effect of Umbilical Cord Clamping Time on Newborns

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.

  1. for normal newborn (apgar score over 7), regardless term or preterm,normal birth or cesarean section born: experimental group1: waiting for 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 newborn 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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Newborn
  • Umbilical Cord
Procedure: different time of umbilical cord clamping
  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.

Other Name: DELAYED CORD CLAMPING AND IMMIDIATE CORD CLAMPING
Not Provided
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
June 2011
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • all living baby after birth, including term, preterm, normal birth, cesarean section, apgar score over 7 or less than that.

Exclusion Criteria:

  • still birth
Both
up to 6 Months
No
China
 
NCT01029496
hainanmc
Yes
huangyuanhua, hainan medical college
Hainan Medical College
Not Provided
Study Director: hua shao ping, professor director of ob&gny dpt.of appendix hospital of hainan medical college
Hainan Medical College
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP