Premature Birth
Conditions
Keywords
Delayed cord clamping, Umbilical cord, Preterm, Cord milking
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.
Interventions
PROCEDUREDelayed cord clamping
Delay cord clamping for 30 seconds after birth
PROCEDUREMilking of the cord
Milking of the cord 4 times in 10 seconds
Sponsors
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Neonatal Event | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Maternal estimated blood loss | up to 1 hour after delivery | Estimated blood loss at 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 | Requirement and length of phototherapy |
| Ionotropic support | up to 24 weeks after birth | Requirement and length of ionotropic support |
| 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 | Time period between delivery of the baby and delivery of the placenta |
| 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 | — |
| Ventilator time | up to 24 weeks after birth | — |
Outcome results
None listed