The PREMOD Trial: A Randomized Controlled Trial of Umbilical Cord Milking vs. Delayed Cord Clamping in Premature Infants
Completed · Not applicable
Conditions studied: Intraventricular Hemorrhage
In brief
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.
Key facts
- Study ID
- NCT01866982
- Run by
- Sharp HealthCare
- People needed
- 197
- Starts
- 2013-07-02
- Expected to finish
- 2018-01-10
- Last updated by the study team
- 2018-05-24
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Loma Linda Medical Center — Loma Linda, California, United States
- Sharp Mary Birch — San Diego, California, United States
- University of California, San Diego — San Diego, California, United States
Full record on ClinicalTrials.gov
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