Delayed Umbilical Cord Clamping - C-section Pilot



Status:Completed
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2013
End Date:November 2014

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Delayed Umbilical Cord Clamping For Term Infants: A Pilot Safety Trial During Cesarean Deliveries

This is a pilot study of delayed cord clamping (DCC) at progressively longer intervals (90
to 120 seconds) during elective cesarean deliveries of term infants. The investigators
hypothesize that the pilot trial of DCC in cesarean sections will demonstrate safety of this
procedure for mothers and babies.

Despite expert recommendations to delay clamping the cord for at least 2 minutes, early cord
clamping remains a common obstetrical practice. The World Health Organization has noted that
data on cesarean deliveries are more limited, particularly with respect to long-term effects
in infants. Recently, the American College of Obstetrics and Gynecology also noted in a
committee statement that " the ideal time for clamping of the umbilical cord in cesarean
section vs. vaginal birth is a particularly important area for future research".

The objective of this study is to conduct a pilot trial of delayed cord clamping during
cesarean deliveries to determine if progressively longer intervals of cord clamping are
feasible and not related to poorer maternal and neonatal outcomes as compared to outcomes
from historical controls. We will offer study entry for women planning elective cesarean
delivery to collect prospective data on progressively longer intervals, analyzing outcomes
for each time interval to ensure they are clinically acceptable, prior to extending the
interval another 30 s. We anticipate approximately 20 women at each interval (90 and 120
sec) and will perform hemoglobin analysis on the infants specifically for this study. If
intraoperative blood loss is clinically deemed excessive, or mother or baby are unstable,
the cord will be clamped.

Inclusion Criteria:Subjects that are pregnant (women 18 years of age and older) and
scheduled for an elective C-section at ≥ 37 weeks gestation will be eligible for the
study.

Exclusion Criteria:

Pregnant women that do not plan on having a C-section and individuals that are not
pregnant. Pregnant women that are medically unstable, have poorly controlled diabetes
mellitus, multiple gestations, anomalous fetuses and/or severe intrauterine growth
retardation will be excluded. Adults unable to consent will not be included
We found this trial at
1
site
2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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mi
from
Sacramento, CA
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