Immediate VS Delayed Cord Clamping on Newborns

Phase 1

• Conditions: Newborn; Umbilical Cord

• Registration Number: NCT01029496
• Lead Sponsor: Hainan Medical College

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.

Study Timeline

• Status Verified: 2009-09
• Study Start: 2009-09
• Study First Submitted: 2009-12-09
• Study First Submitted QC: 2009-12-09
• Study First Posted: 2009-12-10
• Last Update Submitted: 2010-03-01
• Last Update Posted: 2010-03-02
• Primary Completion: 2010-09
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
hemoglobin level of the baby 1 month after birth	2 years

Secondary Outcome Measures

Name	Time	Method
departure time of the umbilical cord	2 years

Trial Locations

Locations (1)

Hainan Medical College Appendix Hospital; 🇨🇳 Haikou, Hainan, China