Immediate VS Delayed Cord Clamping on Newborns

Sponsor
Hainan Medical College (Other)
Overall Status
Unknown status
CT.gov ID
NCT01029496
Collaborator
(none)
120
1
21
5.7

Study Details

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
  • 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.

  1. 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
Anticipated 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 :
Sep 1, 2009
Anticipated Primary Completion Date :
Sep 1, 2010
Anticipated Study Completion Date :
Jun 1, 2011

Outcome Measures

Primary Outcome Measures

  1. hemoglobin level of the baby 1 month after birth [2 years]

Secondary Outcome Measures

  1. departure time of the umbilical cord [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 6 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Hainan Medical College Appendix Hospital Haikou Hainan China 571101

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01029496
Other Study ID Numbers:
  • hainanmc
First Posted:
Dec 10, 2009
Last Update Posted:
Mar 2, 2010
Last Verified:
Sep 1, 2009

Study Results

No Results Posted as of Mar 2, 2010