None listed
Conditions
Brief summary
Waiting at least 60 seconds before clamping the umbilical cord ("deferred cord clamping") is recommended in uncomplicated pregnancies to reduce anaemia, death and disability. However, babies with a heart defect diagnosed before birth have not been included in the studies on which these recommendations were based. This study will examine whether deferred cord clamping improves the proportion of red blood cells ("haematocrit”) in the blood of babies born at or after 35+0 weeks of pregnancy with a serious heart defect ("critical congenital heart disease") that was diagnosed before birth, compared to immediate cord clamping. It will also examine the feasibility of a larger definitive trial that would examine whether deferred cord clamping improves health outcomes for these babies in the longer term. Data will be collected to approx. 3-4 months of age, or to approx. 12 months of age subject to further funding. A total of 90 infants will be recruited.
Interventions
The intervention is delayed clamping of the umbilical cord, for at least 60 seconds after delivery. To administer the intervention: * A nominated staff member (e.g. obstetrician or midwife) will call out clearly as soon as the infant has been delivered * A nominated staff member (e.g. neonatal team member) will start the clock on the resuscitation trolley when the infant has been delivered and call out the time clearly in seconds. * A nominated staff member (e.g. neonatal team member) will time and record the duration of the allocated intervention * A nominated staff member (e.g. obstetrician or midwife) will record the time when the cord has been clamped. The cord should be clamped 6 centimetres from the umbilicus. During the delay, the infant will be held in a sterile towel, at or up to 30 centimetres below the level of the vaginal introitus (for vaginal delivery) or the level of the incision (for Caesarean section). Time in seconds of cord clamping should be recorded. After cutting of the cord, the infant will receive routine care. If an infant is deemed to required immediate resuscitation, delayed cord clamping should be abandoned and the cord clamped immediately with time in seconds of cord clamping accurately recorded. Time in seconds of cord clamping should be recorded for all infants. A secondary outcome of this study is to measure compliance to delayed cord clamping. This will be obtained by recording the reasons for not complying with the delay of 60 seconds in the broad categories of concern about pregnant individual, concern about infant, parent preference and others. Study teams should be counselled appropriately if a sustained pattern or non-compliance is determined by the coordinating centre as part of data monitoring.
The intervention is deferred clamping of the umbilical cord, for at least 60 seconds after delivery. To administer the intervention: * A nominated staff member (e.g. obstetrician or midwife) will call out clearly as soon as the infant has been delivered * A nominated staff member (e.g. neonatal team member) will start the clock on the resuscitation trolley when the infant has been delivered and call out the time clearly in seconds. * A nominated staff member (e.g. neonatal team member) will time and record the duration of the allocated intervention * A nominated staff member (e.g. obstetrician or midwife) will record the time when the cord has been clamped. The cord should be clamped 6 centimetres from the umbilicus. During the delay, the infant will be held in a sterile towel, at or up to 30 centimetres below the level of the vaginal introitus (for vaginal delivery) or the level of the incision (for Caesarean section). Time in seconds of cord clamping should be recorded. After cutting of the cord, the infant will receive routine care. If an infant is deemed to required immediate resuscitation, deferred cord clamping should be abandoned and the cord clamped immediately with time in seconds of cord clamping accurately recorded. Time in seconds of cord clamping should be recorded for all infants. A secondary outcome of this study is to measure compliance to deferred cord clamping. This will be obtained by recording the reasons for not complying with the delay of 60 seconds in the broad categories of concern about pregnant individual, concern about infant, parent preference and others. Study teams should be counselled appropriately if a sustained pattern or non-compliance is determined by the coordinating centre as part of data monitoring.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Term or late preterm foetus, greater than 34 weeks gestation, with an antenatal diagnosis of critical congenital heart disease diagnosed by foetal cardiologist 2. Antenatal foetal cardiovascular disease severity scale (FDSS) score of 3-6 (inclusive) 3. Written informed consent provided by the pregnant individual (parent)
Exclusion criteria
1. Foetuses with known genetic or major extracardiac anomalies, including Trisomy 21 2. Foetuses for whom palliative care is planned from delivery 3. Foetuses of pregnant individuals with current placental abruption or placenta previa