Timing of Cord Clamping and Neonatal Hemoglobin

NCT00371228 | Withdrawn

• 1 other identifier: 2005010
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia

Keywords

cord clamping; hematocrit; hemoglobin; timing

Outcome Measures

Primary Outcomes (1)

• hemoglobin

  day of birth

Study Arms (2)

1

EXPERIMENTAL

Umbilical cord not cut until pulsation stops, in order to provide additional blood to newborn.

Procedure: Delay of umbilical cord clamping

2

NO INTERVENTION

Umbilical cord cut soon after birth without waiting for pulsing to stop.

Interventions

Delay of umbilical cord clamping PROCEDURE

Umbilical cord delayed until pulsation stops.

1

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oklahoma State University Center for Health Sciences: lead

Study Sites (1)

OSU Houston Center

Tulsa, Oklahoma, 74127, United States

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• John M. Beal, D.O.

  Oklahoma State University Center for Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2006
• First Posted: September 1, 2006
• Study Start: September 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: October 5, 2020

Record last verified: 2020-10

Locations

US (1)