| Trial name or title |
Delayed umbilical cord clamping versus cord milking in preterm neonate ‐ a randomised, controlled trial |
| Methods |
Randomised controlled trial |
| Participants |
Singleton or multiples pregnancies in women admitted for medically indicated delivery or in advanced spontaneous preterm labour with imminent delivery at 24 0/7 ‐ 28 6/7 weeks' gestation. Women ages 18 and older |
| Interventions |
Intervention 1
DCC: delay cord clamping for 30 seconds after birth
Intervention 2
UCM: milking of the cord 4 times in 10 seconds
Comparator
ECC: immediate cord clamping |
| Outcomes |
Primary
Adverse neonatal event: composite of bronchopulmonary dysplasia (BPD), necrotising enterocolitis (NEC), grade 3 or 4 intraventricular haemorrhage (IVH) or periventricular leukomalacia (PVL), or death prior to discharge home
Secondary
Maternal estimated blood loss Estimated blood loss at delivery Any grade IVH Severe IVH (grade 3 or 4 PVL BPD Peak transcutaneous and/or serum bilirubin concentrations Phototherapy Requirement and length of phototherapy Ionotropic support Requirement and length of inotropic support NICU length of stay Sepsis NEC RDS Number of blood transfusions while in the neonatal intensive care unit Ventilator time Apgar score < 7 at 5 minutes Umbilical cord pH < 7.0 Blood pressure on admission to neonatal intensive care unit Polycythemia Hematocrit on admission to NICU Neonatal death Length of 3rd stage of labour Time period between birth of the baby and delivery of the placenta Use of uterotonic agents Maternal blood transfusion Manual removal of placenta Operating time for caesarean delivery
|
| Starting date |
December 2011 to January 2013 |
| Contact information |
Rita W Driggers, MD, Washington Hospital Center, Georgetown University Hospital |
| Notes |
Trial registration: NCT01393834
Sponsors: Medstar Research Institute
Declarations of interest:
Comparisons 1;2;3 |
