Delayed Clamping and Milking the Umbilical Cord in Preterm Infants



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:Any
Updated:12/30/2018
Start Date:March 2014
End Date:July 8, 2018

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Delayed Clamping and Milking the Umbilical Cord Prior to Clamping in Preterm Infants and the Effect of Neonatal Outcomes

This is a randomized controlled trial that will compare the effects of delayed umbilical cord
clamping to umbilical cord milking in preterm infants (less than 34 weeks gestation). The
infants' hemoglobin and hematocrit levels in the Neonatal Intensive Care Unit (NICU) will be
evaluated, as well as the rates of necrotizing enterocolitis, intraventricular hemorrhage,
and blood transfusions. The hypothesis is that milking the umbilical cord prior to clamping
is superior to simply delayed cord clamping, presumably providing an increased blood volume
to the preterm neonate improving its outcomes.

The optimal timing for clamping the umbilical cord after birth in preterm infants has been a
subject of controversy and debate for many years. It has been until recently the standard
practice in ob/gyn to clamp the umbilical cord immediately post delivery to allow for
immediate transition resuscitation of the neonate, especially in preterm infants. Due to the
fact that optimal timing for cord clamping has yet to be definitively established in the
preterm population, more information is needed. Immediate cord clamping, however, could
preclude the infant from an extra boost in blood volume that may prove beneficial later in
the newborn life. Directly comparing the recently recommended practice of delayed umbilical
cord clamping to milking the umbilical cord prior to clamping has the potential to prove
beneficial for the neonates in question, as well as change daily obstetrical practices. In
this study all infants below 34 weeks will be randomized into one of two groups: delayed cord
clamping and milking the umbilical cord prior to clamping. The decision was made not to
include immediate cord clamping due to a recent American Congress of Obstetricians and
Gynecologists (ACOG) recommendation that all preterm infants have their cord clamping be
delayed. Their outcomes will be measured by serial hemoglobin and hematocrit levels while in
the NICU, the incidence of necrotizing enterocolitis, incidence of intraventricular
hemorrhage, and the need for neonatal blood transfusions.

Inclusion Criteria:

- Admitted to Labor & Delivery at Good Samaritan TriHealth Hospital in Cincinnati, Ohio
with expected/possible preterm delivery between 23-34 weeks gestation

- Care provided by Good Samaritan TriHealth Hospital's Faculty Medical Center or
Tri-State Maternal Fetal Medicine

Exclusion Criteria:

- Declined to participate

- Known congenital anomalies

- Precipitous delivery preventing completion of the protocol

- Placental abruption around the time of or as indication for delivery

- Mother has uterine rupture

- Non reassuring fetal heart tracing (FHT) immediately prior/leading to delivery

- Multiple gestation

- Parvo B19

- Infants known to be at risk of anemia due to isoimmunization (mother has red blood
cell antibodies
We found this trial at
1
site
Cincinnati, Ohio 45220
Phone: 513-862-2341
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mi
from
Cincinnati, OH
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