Status:
COMPLETED
The PREMOD Trial: A Randomized Controlled Trial of Umbilical Cord Milking vs. Delayed Cord Clamping in Premature Infants
Lead Sponsor:
Sharp HealthCare
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Intraventricular Hemorrhage
Eligibility:
All Genders
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 2 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2018
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT01866982
Start Date
July 2 2013
End Date
January 10 2018
Last Update
May 24 2018
Active Locations (3)
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1
Loma Linda Medical Center
Loma Linda, California, United States, 92350
2
Sharp Mary Birch
San Diego, California, United States, 92123
3
University of California, San Diego
San Diego, California, United States, 92130