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Timing of Cord Clamping and Neonatal Hemoglobin

This study has been withdrawn prior to enrollment.
(PI left university)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00371228
First Posted: September 1, 2006
Last Update Posted: May 19, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Oklahoma State University Center for Health Sciences
  Purpose

The purpose of this study is to determine whether the timing of the clamping of the umbilical cord after delivery has an impact on neonatal hemoglobin and hematocrit, tests that determine the number of red cells in the blood and their ability to carry oxygen. The study hypothesis is that delaying cord clamping until cord pulsation has ceased will increase the neonatal blood volume and thereby increase the hemoglobin and hematocrit.

We propose to recruit 150 women who present for vaginal delivery at Tulsa Regional Medical Center. Half of the women will be randomly assigned to the immediate clamping group, which will entail clamping of the umbilical cord within six seconds of delivery of the fetal shoulders. The other half of the volunteers will be assigned to the delayed clamping group, which will entail clamping the cord after a palpable pulse has ceased, or after 10 minutes. The infants of mothers in both groups will have blood drawn for a hemoglobin and hematocrit at the time of the routine PKU heel stick, usually is performed within 18-24 hours of delivery.

Statistical differences between the blood counts of infants in the control and study groups will be compared using independent samples t tests.


Condition Intervention
Anemia Procedure: Delay of umbilical cord clamping

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Delayed Versus Immediate Cord Clamping and Changes in Neonatal Hemoglobin

Further study details as provided by Oklahoma State University Center for Health Sciences:

Primary Outcome Measures:
  • hemoglobin [ Time Frame: day of birth ]

Estimated Enrollment: 150
Study Start Date: September 2006
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Umbilical cord not cut until pulsation stops, in order to provide additional blood to newborn.
Procedure: Delay of umbilical cord clamping
Umbilical cord delayed until pulsation stops.
No Intervention: 2
Umbilical cord cut soon after birth without waiting for pulsing to stop.
Procedure: Delay of umbilical cord clamping
Umbilical cord delayed until pulsation stops.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy women and their newborn infants delivered at Tulsa Regional Medical Center,
  • between the ages of 18 and 34,
  • full term (37 to 41 weeks),
  • singleton pregnancy at the time of delivery

Exclusion Criteria:

  • Delivery complicated by non-reassuring fetal heart tones,
  • preeclampsia,
  • eclampsia,
  • chronic hypertension,
  • meconium-stained amniotic fluid,
  • fetal anomalies or
  • any other condition which could require immediate newborn evaluation by nursery personnel at the time of delivery. Infants requiring operative delivery by forceps or vacuum also will be excluded.
  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): NCT00371228


Locations
United States, Oklahoma
OSU Houston Center
Tulsa, Oklahoma, United States, 74127
Sponsors and Collaborators
Oklahoma State University Center for Health Sciences
Investigators
Principal Investigator: John M. Beal, D.O. Oklahoma State University Center for Health Sciences
  More Information

Responsible Party: Dr. J. Martin Beal, assistant professor of Ob/Gyn, Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier: NCT00371228     History of Changes
Other Study ID Numbers: 2005010
First Submitted: August 30, 2006
First Posted: September 1, 2006
Last Update Posted: May 19, 2008
Last Verified: May 2008

Keywords provided by Oklahoma State University Center for Health Sciences:
cord clamping
hematocrit
hemoglobin
timing