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Trial of Immediate vs. Delayed Cord Clamping in the Preterm Neonate

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ClinicalTrials.gov Identifier: NCT00579839
Recruitment Status : Completed
First Posted : December 24, 2007
Last Update Posted : January 20, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To determine the short and long term effects of placental transfusion at birth by milking and delayed cord clamping of the umbilical cord in neonates born between 24 weeks 0 days and 34 weeks 0 days weeks' gestation.

Condition or disease Intervention/treatment
PreTerm Birth PreTerm Neonate Procedure: Delayed Cord Clamping Procedure: Immediate Cord Clamping

Detailed Description:
This study is intended to be a randomized controlled trial comparing immediate cord clamping which represents the current standard of care at Oklahoma University Medical Center with delayed cord clamping among preterm neonates born between 24 weeks and 34 weeks 0 days weeks' gestation. Allocation sequence will be generated by simple randomization using random number table in the stratum 24-28 weeks 6 days and 29 weeks to 34 weeks 0 days weeks' gestation stratum.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Immediate Versus Delayed Cord Clamping in the Preterm Neonate
Study Start Date : October 2006
Primary Completion Date : May 2011
Study Completion Date : May 2011
Arms and Interventions

Arm Intervention/treatment
Experimental: A
Delayed Cord Clamping
Procedure: Delayed Cord Clamping
Delayed Cord Clamping: 30-35 seconds after birth
Active Comparator: B
Immediate cord clamping
Procedure: Immediate Cord Clamping
Immediate Cord Clamping: within 5 seconds of birth


Outcome Measures

Primary Outcome Measures :
  1. To determine the short and long term effects of placental transfusion at birth by milking and delayed cord clamping of the umbilical cord in neonates born between 24 weeks 0 days and 34 weeks 0 days weeks' gestation. [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Singleton pregnancies
  • Signed consent to participate in the trial

Exclusion Criteria:

  • Major fetal anomaly or known fetal chromosomal abnormalities
  • Multiple gestation
  • Mothers with pregestational and gestational diabetes
  • Refusal to participate in the trial
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00579839


Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Andrew Elimian, MD University of Oklahoma
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00579839     History of Changes
Other Study ID Numbers: CordClampingElimian
First Posted: December 24, 2007    Key Record Dates
Last Update Posted: January 20, 2012
Last Verified: January 2012

Keywords provided by University of Oklahoma:
PreTerm Birth
PreTerm Neonate
High risk pregnancy
Preterm Baby
Premature Baby
Cord Clamping
Milking the cord

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications