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NCT02195037 Clinical Trial

Changes in Cardiac Output During Delayed Umbilical Cord Clamping

Cardiac Output, Low Clinical Trial

Official title:
Changes in Cardiac Output During Delayed Umbilical Cord Clamping

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02195037
Other study ID # CO-DCC
Secondary ID
Status Completed
Phase N/A
First received July 17, 2014
Last updated May 18, 2015
Start date July 2014
Est. completion date December 2014

Study information
Verified date August 2014
Source Sharp HealthCare
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date December 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group N/A to 1 Minute
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Sharp Mary Birch Hospital for Women and Newborns San Diego California

Sponsors (1)
Lead Sponsor Collaborator
Sharp HealthCare

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cardiac Output 5 minutes of Life No
Secondary Stroke Volume 5 Minutes of Life No
Secondary Bilirubin level until discharge No
Secondary Hemoglobin level until discharge No
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