Immediate VS Delayed Cord Clamping on Newborns

NCT ID: NCT01029496

Last Updated: 2010-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-06-30

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.

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.

Conditions

Newborn; Umbilical Cord

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

DELAYED CORD CLAMPING AND IMMIDIATE CORD CLAMPING

Eligibility 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

• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hainan Medical College

OTHER

Sponsor Role: lead

Responsible Party

hainan medical college

Principal Investigators

hua shao ping, professor

Role: STUDY_DIRECTOR

director of ob&gny dpt.of appendix hospital of hainan medical college

Locations

Hainan Medical College Appendix Hospital

Haikou, Hainan, China

Site Status: RECRUITING

Countries

China

Facility Contacts

zhang hong yu, master

Role: primary

hong1029@sohu.com

086-13158942317

References

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

Reference Type: BACKGROUND

Other Identifiers

hainanmc

Identifier Type: -

Identifier Source: org_study_id