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

Sharp HealthCare

Status

Completed

Conditions

Intraventricular Hemorrhage

Treatments

Procedure: Delayed Cord Clamping

Procedure: Umbilical Cord Milking

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01866982

PREMOD

R03HD072934-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

197 patients

Sex

All

Volunteers

No Healthy Volunteers

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