The PREMOD Trial: A Randomized Controlled Trial of Umbilical Cord Milking vs. Delayed Cord Clamping in Premature Infants



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:5/26/2018
Start Date:July 2, 2013
End Date:January 10, 2018

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Trial Summary
Trial Overview
Inclusion Criteria
Premature babies can be very sick and have bleeding in the brain. Giving babies more blood
before cutting the umbilical cord by delayed cord clamping or umbilical cord milking has been
shown to reduce the risk of bleeding in the brain. This may be related to improving perfusion
to the brain. However, some studies suggest that delayed cord clamping may not increase
hemoglobin or blood volume in babies delivered by cesarean section. Milking the umbilical
cord may give more blood in babies delivered by Cesarean Section may improve perfusion and
reduce bleeding in the brain.


Inclusion Criteria:

- Singleton or multiples pregnancies in patients admitted for medically indicated
delivery or in advanced spontaneous preterm labor with imminent delivery at 23 0/7 -
31 6/7 weeks gestation

Exclusion Criteria:

- Planned vaginal breech delivery

- Major fetal abnormalities (defined as those that are lethal or require prenatal or
postnatal surgery)

- Fetal death in utero

- Red cell isoimmunization

- Patients who are incapable of informed consent (unconscious, severely ill, mentally
handicapped), or are unwilling to undergo randomization

- Placenta accreta or abruption
We found this trial at
3
sites
Sharp Mary Birch
San Diego, California 92123
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San Diego, CA
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Loma Linda Medical Center
Loma Linda, California 92354
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from
Loma Linda, CA
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University of California, San Diego
San Diego, California 92093
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mi
from
San Diego, CA
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