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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00579839
First received: December 18, 2007
Last updated: January 19, 2012
Last verified: January 2012
  Purpose

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 Intervention
PreTerm Birth
PreTerm Neonate
Procedure: Delayed Cord Clamping
Procedure: Immediate Cord Clamping

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Immediate Versus Delayed Cord Clamping in the Preterm Neonate

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: October 2006
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00579839     History of Changes
Other Study ID Numbers: CordClampingElimian
Study First Received: December 18, 2007
Last Updated: January 19, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 20, 2014