Clinical trial NCT01393834: Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate
Official title: Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate - a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Premature Birth
Keywords: Delayed cord clamping
Umbilical cord
Preterm
Cord milking
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2011-07-13
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


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)

Primary outcomes:
measure: Adverse Neonatal Event
timeFrame: up to 24 weeks after birth
Secondary outcomes:
measure: Maternal estimated blood loss
timeFrame: up to 1 hour after delivery
measure: Any grade intraventricular hemorrhage
timeFrame: up to 24 weeks after birth
measure: Severe intraventricular hemorrhage (grade 3 or 4)
timeFrame: up to 24 weeks after birth
measure: Periventricular leukomalacia
timeFrame: up to 24 weeks after birth
measure: Bronchopulmonary dysplasia
timeFrame: up to 24 weeks after birth
measure: Peak transcutaneous and/or serum bilirubin concentrations
timeFrame: up to 24 weeks after birth
measure: Phototherapy
timeFrame: up to 24 weeks after birth
measure: Ionotropic support
timeFrame: up to 24 weeks after birth
measure: Neonatal intesive care unit (NICU) length of stay
timeFrame: up to 24 weeks after birth
measure: Sepsis
timeFrame: up to 24 weeks after birth
measure: Necrotizing enterocolitis
timeFrame: up to 24 weeks after birth
measure: Respiratory distress syndrome
timeFrame: up to 24 weeks after birth
measure: Number of blood transfusions while in the neonatal intensive care unit
timeFrame: up to 24 weeks after birth
measure: Ventilator time
timeFrame: up to 24 weeks after birth
measure: Apgar score <7 at 5 minutes
timeFrame: at 5 minutes after birth
measure: Umbilical cord pH < 7.0
timeFrame: up to 30 minutes after birth
measure: Blood pressure on admission to neonatal intensive care unit
timeFrame: at 30 minutes after birth
measure: Polycythemia
timeFrame: up to 24 hours of life
measure: Hematocrit on admission to neonatal intensive care unit
timeFrame: up to 4 hours after birth
measure: Neonatal death
timeFrame: up to 24 weeks of life
measure: Length of 3rd stage of labor
timeFrame: up to 1 hour after birth
measure: Use of uterotonic agents
timeFrame: up to 1 hour after birth
measure: Maternal blood transfusion
timeFrame: up to 5 days after delivery
measure: Manual removal of placenta
timeFrame: up to 1 hour after birth
measure: Operating time for cesarean delivery
timeFrame: up to 3 hours after birth
Other outcomes:
Locations:
Study officials:
affiliation: Washington Hospital Center, Georgetown University Hospital
name: Rita W Driggers, MD
role: PRINCIPAL_INVESTIGATOR
References: