Changes in Cardiac Output During Delayed Umbilical Cord Clamping

May 18, 2015 updated by: Anup Katheria, M.D., Sharp HealthCare
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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 minute (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiac Output
Time Frame: 5 minutes of Life
5 minutes of Life

Secondary Outcome Measures

Outcome Measure
Time Frame
Stroke Volume
Time Frame: 5 Minutes of Life
5 Minutes of Life
Bilirubin level
Time Frame: until discharge
until discharge
Hemoglobin level
Time Frame: until discharge
until discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sharp HealthCare

Investigators

  • Principal Investigator: Anup Katheria, MD, Sharp HealthCare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

July 17, 2014

First Submitted That Met QC Criteria

July 17, 2014

First Posted (Estimate)

July 21, 2014

Study Record Updates

Last Update Posted (Estimate)

May 20, 2015

Last Update Submitted That Met QC Criteria

May 18, 2015

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CO-DCC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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