Immediate VS Delayed Cord Clamping on Newborns

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified September 2009 by Hainan Medical College.
Recruitment status was: Recruiting

Sponsor:

Information provided by:

Hainan Medical College

ClinicalTrials.gov Identifier:

NCT01029496

First received: December 9, 2009

Last updated: March 1, 2010

Last verified: September 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

December 9, 2009

Last Updated Date

March 1, 2010

Start Date ^ICMJE

September 2009

Estimated Primary Completion Date

September 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01029496 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

departure time of the umbilical cord [ Time Frame: 2 years ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Immediate VS Delayed Cord Clamping on Newborns

Official Title ^ICMJE

Effect of Umbilical Cord Clamping Time on Newborns

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

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.
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 Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Participant)
Primary Purpose: Prevention

Condition ^ICMJE

Newborn
Umbilical Cord

Intervention ^ICMJE

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.

Other Name: DELAYED CORD CLAMPING AND IMMIDIATE CORD CLAMPING

Study Arms

Not Provided

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

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

June 2011

Estimated Primary Completion Date

September 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

up to 6 Months (Child)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

China

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01029496

Other Study ID Numbers ^ICMJE

hainanmc

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

huangyuanhua, hainan medical college

Study Sponsor ^ICMJE

Hainan Medical College

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

hua shao ping, professor

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

PRS Account

Hainan Medical College

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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