NCT01029496

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 10, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 2, 2010

Status Verified

September 1, 2009

Enrollment Period

1 year

First QC Date

December 9, 2009

Last Update Submit

March 1, 2010

Conditions

Keywords

umbilical CORD CLAMPINGNeonatal anemiaOmphalitis

Outcome Measures

Primary Outcomes (1)

  • hemoglobin level of the baby 1 month after birth

    2 years

Secondary Outcomes (1)

  • departure time of the umbilical cord

    2 years

Interventions

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.

Also known as: DELAYED CORD CLAMPING AND IMMIDIATE CORD CLAMPING

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • all living baby after birth, including term, preterm, normal birth, cesarean section, apgar score over 7 or less than that.

You may not qualify if:

  • still birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hainan Medical College Appendix Hospital

Haikou, Hainan, 571101, China

RECRUITING

Related 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

    BACKGROUND

MeSH Terms

Conditions

Anemia, Neonatal

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

AnemiaHematologic DiseasesHemic and Lymphatic DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • hua shao ping, professor

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 9, 2009

First Posted

December 10, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2010

Study Completion

June 1, 2011

Last Updated

March 2, 2010

Record last verified: 2009-09

Locations