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Immediate VS Delayed Cord Clamping on Newborns

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ClinicalTrials.gov Identifier: NCT01029496
Recruitment Status : Unknown
Verified September 2009 by Hainan Medical College.
Recruitment status was:  Recruiting
First Posted : December 10, 2009
Last Update Posted : March 2, 2010
Sponsor:
Information provided by:

Study Description
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.

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

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effect of Umbilical Cord Clamping Time on Newborns
Study Start Date : September 2009
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : June 2011
Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. hemoglobin level of the baby 1 month after birth [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. departure time of the umbilical cord [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: December 10, 2009    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: September 2009

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