Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate - a Randomized, Controlled Trial

Medstar Health Research Institute0 sites2 target enrollmentDecember 2011

ConditionsPremature Birth

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Premature Birth
Sponsor: Medstar Health Research Institute
Enrollment: 2
Primary Endpoint: Adverse Neonatal Event
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This study is being done to evaluate if delaying cord clamping or milking the umbilical cord of the preterm infant has health benefits for the baby. Timing of clamping of the cord varies among doctors, but there is information that shows that delaying clamping of the umbilical cord in premature infants may reduce the rate of the baby needing a blood transfusion, decrease the risk of infection and bleeding in the head.

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

January 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Medstar Health Research Institute

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Singleton or multiples pregnancies in patients admitted for medically indicated delivery or in advanced spontaneous preterm labor with imminent delivery at 24 0/7 - 28 6/7 weeks gestation
•Women ages 18 and older

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 previa or other known abnormal placentation (e.g. placenta accreta)

Outcomes

Primary Outcomes

Adverse Neonatal Event

Time Frame: up to 24 weeks after birth

composite of bronchopulmonary dysplasia (BPD), necrotising eneterocolitis (NEC), grade 3 or 4 intraventricular hemorrhage (IVH) or periventricular leukomalacia (PVL), or death prior to discharge home

Secondary Outcomes

Maternal estimated blood loss(up to 1 hour after delivery)
Any grade intraventricular hemorrhage(up to 24 weeks after birth)
Severe intraventricular hemorrhage (grade 3 or 4)(up to 24 weeks after birth)
Periventricular leukomalacia(up to 24 weeks after birth)
Bronchopulmonary dysplasia(up to 24 weeks after birth)
Peak transcutaneous and/or serum bilirubin concentrations(up to 24 weeks after birth)
Phototherapy(up to 24 weeks after birth)
Ionotropic support(up to 24 weeks after birth)
Neonatal intesive care unit (NICU) length of stay(up to 24 weeks after birth)
Sepsis(up to 24 weeks after birth)
Necrotizing enterocolitis(up to 24 weeks after birth)
Respiratory distress syndrome(up to 24 weeks after birth)
Number of blood transfusions while in the neonatal intensive care unit(up to 24 weeks after birth)
Ventilator time(up to 24 weeks after birth)
Apgar score <7 at 5 minutes(at 5 minutes after birth)
Umbilical cord pH < 7.0(up to 30 minutes after birth)
Blood pressure on admission to neonatal intensive care unit(at 30 minutes after birth)
Polycythemia(up to 24 hours of life)
Hematocrit on admission to neonatal intensive care unit(up to 4 hours after birth)
Neonatal death(up to 24 weeks of life)
Length of 3rd stage of labor(up to 1 hour after birth)
Use of uterotonic agents(up to 1 hour after birth)
Maternal blood transfusion(up to 5 days after delivery)
Manual removal of placenta(up to 1 hour after birth)
Operating time for cesarean delivery(up to 3 hours after birth)