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
  Purpose

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.


Condition Intervention Phase
Newborn
Umbilical Cord
Procedure: different time of umbilical cord clamping
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Effect of Umbilical Cord Clamping Time on Newborns

Further study details as provided by Hainan Medical College:

Primary Outcome Measures:
  • hemoglobin level of the baby 1 month after birth [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • departure time of the umbilical cord [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: September 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Detailed Description:
  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.

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029496

Locations
China, Hainan
Hainan Medical College Appendix Hospital Recruiting
Haikou, Hainan, China, 571101
Contact: zhang hong yu, master    086-13158942317    hong1029@sohu.com   
Principal Investigator: zhang hong yu, master         
Sponsors and Collaborators
Hainan Medical College
Investigators
Study Director: hua shao ping, professor director of ob&gny dpt.of appendix hospital of hainan medical college
  More Information

Publications:
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

Responsible Party: huangyuanhua, hainan medical college
ClinicalTrials.gov Identifier: NCT01029496     History of Changes
Other Study ID Numbers: hainanmc
Study First Received: December 9, 2009
Last Updated: March 1, 2010
Health Authority: China: Ethics Committee

Keywords provided by Hainan Medical College:
umbilical CORD CLAMPING
Neonatal anemia
Omphalitis

ClinicalTrials.gov processed this record on September 18, 2014