Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate
- Conditions
- Premature Birth
- Interventions
- Procedure: Milking of the cordProcedure: Delayed cord clamping
- Registration Number
- NCT01393834
- Lead Sponsor
- Medstar Health Research Institute
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 2
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Milking of the cord Milking of the cord Milking of the cord 4 times in 10 seconds Delayed cord clamping Delayed cord clamping Delayed cord clamping for 30 seconds
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Manual removal of placenta up to 1 hour after birth Operating time for cesarean delivery up to 3 hours 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
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 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