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

Primary Purpose

PreTerm Birth, PreTerm Neonate

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Delayed Cord Clamping
Immediate Cord Clamping
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PreTerm Birth focused on measuring PreTerm Birth, PreTerm Neonate, High risk pregnancy, Preterm Baby, Premature Baby, Cord Clamping, Milking the cord

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Oklahoma Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Delayed Cord Clamping

Immediate cord clamping

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
December 18, 2007
Last Updated
January 19, 2012
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT00579839
Brief Title
Trial of Immediate vs. Delayed Cord Clamping in the Preterm Neonate
Official Title
A Randomized Controlled Trial of Immediate Versus Delayed Cord Clamping in the Preterm Neonate
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreTerm Birth, PreTerm Neonate
Keywords
PreTerm Birth, PreTerm Neonate, High risk pregnancy, Preterm Baby, Premature Baby, Cord Clamping, Milking the cord

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Delayed Cord Clamping
Arm Title
B
Arm Type
Active Comparator
Arm Description
Immediate cord clamping
Intervention Type
Procedure
Intervention Name(s)
Delayed Cord Clamping
Intervention Description
Delayed Cord Clamping: 30-35 seconds after birth
Intervention Type
Procedure
Intervention Name(s)
Immediate Cord Clamping
Intervention Description
Immediate Cord Clamping: within 5 seconds of birth
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Elimian, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25415157
Citation
Elimian A, Goodman J, Escobedo M, Nightingale L, Knudtson E, Williams M. Immediate compared with delayed cord clamping in the preterm neonate: a randomized controlled trial. Obstet Gynecol. 2014 Dec;124(6):1075-1079. doi: 10.1097/AOG.0000000000000556.
Results Reference
derived

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

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