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CompletedNCT02195037Updated May 20, 2015

Changes in Cardiac Output During Delayed Umbilical Cord Clamping

An observational study in Cardiac Output, Low, sponsored by Sharp HealthCare. Completed at 1 site in United States. Open to participants aged Up to 1 Minute. Per ClinicalTrials.gov, last updated 2015-05-20.

Sponsored by Sharp HealthCare · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
Up to 1 Minute
Sex
All
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Study summary

Recently, the American College of Obstetricians and Gynecologists (ACOG) recommended a delay of 30-60 seconds in umbilical cord clamping for all newborn infants. This delay allows the newborn to receive his/her own blood from the placenta (placental transfusion) which helps their transition in the first hours of life. The purpose of the study is to learn about the amount of blood flow to and from the baby's heart during normal newborn transition

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Conditions studied

  • Cardiac Output, Low

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Keywords

  • Delayed Cord Clamping
03

In context

Cardiac Output, Low

94 studies on the registry are indexed under Cardiac Output, Low; 15 are open to participants now.

This study's enrollment of 20 is below the median of 60 across 45 observational studies indexed under Cardiac Output, Low.

Browse Cardiac Output, Low studies →

Lead sponsor

Sharp HealthCare is the lead sponsor of 40 studies on the registry; 4 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 1 Minute
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Healthy full term infants delivered by vaginal birth with an estimated gestational age of 37+1 to 41+6 weeks corrected gestational age

Inclusion criteria

  • Healthy full term infants
  • Delivered by vaginal birth
  • Estimated gestational age of 37+0to 41+6 weeks corrected gestational age

Exclusion criteria

Exclusion Criteria:

  • Multiples
  • Known fetal anomalies (including cardiac defects).
  • Instrumentation during delivery (forceps or vacuum)
  • Non-reducible nuchal cord during delivery.
  • Any maternal or neonatal indication requiring immediate cord clamping.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Cardiac Output

    Time frame: 5 minutes of Life

Secondary outcomes

  1. Stroke Volume

    Time frame: 5 Minutes of Life

  2. Bilirubin level

    Time frame: until discharge

  3. Hemoglobin level

    Time frame: until discharge

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Study locations

1 site
  • Sharp Mary Birch Hospital for Women and Newborns
    San Diego, California 92123, United States
08

References and documents

Publications

  • Katheria AC, Wozniak M, Harari D, Arnell K, Petruzzelli D, Finer NN. Measuring cardiac changes using electrical impedance during delayed cord clamping: a feasibility trial. Matern Health Neonatol Perinatol. 2015 May 22;1:15. doi: 10.1186/s40748-015-0016-3. eCollection 2015. PubMed 27057332 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02195037
Lead sponsor
Sharp HealthCare
Responsible party
Anup Katheria, M.D. (Director of Neonatal Research, Sharp HealthCare) — Principal investigator
First posted
Jul 21, 2014
Start date
Jul 2014
Primary completion
Oct 2014
Completion
Dec 2014
Last update
May 20, 2015

Study contacts

Anup Katheria, MD
principal investigator · Sharp HealthCare

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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