Immediate VS Delayed Cord Clamping on Newborns

Newborn Clinical Trial

Official title:

Effect of Umbilical Cord Clamping Time on Newborns

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01029496
• Other study ID #: hainanmc
• Status: Unknown status
• Phase: Phase 1/Phase 2
• First received: December 9, 2009
• Last updated: March 1, 2010
• Start date: September 2009
• Est. completion date: June 2011

Study information

• Verified date: September 2009
• Source: Hainan Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 120
• Est. completion date: June 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Newborn
• Umbilical Cord

Intervention

Procedure:
• different time of umbilical cord clamping
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. 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.

Locations

Country	Name	City	State
China	Hainan Medical College Appendix Hospital	Haikou	Hainan

Sponsors (1)

Lead Sponsor	Collaborator
Hainan Medical College

Country where clinical trial is conducted

China, 

References & 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemoglobin level of the baby 1 month after birth		2 years
Secondary	departure time of the umbilical cord		2 years