None listed
Conditions
Brief summary
Most preterm babies have the umbilical cord clamped within 10 seconds of birth. Placental transfusion is a simple way of giving the baby extra blood at birth by (1) delaying the clamping of the umbilical cord by up to 60 seconds or (2) milking the contents of the umbilical cord into the baby after birth or (3) both methods combined. There is promising evidence from randomised trials that placental transfusion in babies less than 37 weeks of gestation may improve their blood pressure, reduce the number of blood transfusions needed and decrease bleeding into the brain, bowel disease and infection. However, we do not know if babies born before 30 weeks of pregnancy benefit or if placental transfusion increases or decreases death or childhood disability. Despite this uncertainty more doctors are recommending that all preterm babies are given a placental transfusion at birth. It is important to find out if placental transfusion does more good than harm. The Australian Placental Transfusion Pilot Study will enrol up to 100 women who will give birth to babies less than 32 weeks of pregnancy. These participants will be randomly assigned to 4 methods of cord clamping. The 3 mentioned above compared with standard treatment which is to clamp the cord within 10 seconds of birth. The main research question of the pilot study is whether haemoglobin concentration in the first few hours after birth is greatest in babies with which placental transfusion method.
Interventions
The three methods of autologous placental transfusion are:
1. Milking the contents of the umbilical cord:
The obstetrician or midwife clamps and cuts the cord long (3 cm from the placenta or the introitus of the vagina) and hands the baby over to the neonatal team. Then, a neonatal team member untwists the cord and milks the cord into the baby during resuscitation.
2. Delayed cord clamping
The obstetrician or midwife holds the baby as low as possible below the level of the introitus or placent
The three methods of autologous placental transfusion are: 1. Milking the contents of the umbilical cord: The obstetrician or midwife clamps and cuts the cord long (3 cm from the placenta or the introitus of the vagina) and hands the baby over to the neonatal team. Then, a neonatal team member untwists the cord and milks the cord into the baby during resuscitation. 2. Delayed cord clamping The obstetrician or midwife holds the baby as low as possible below the level of the introitus or placenta for 30 – 60 seconds then clamps the cord 6 cm from the umbilicus. If the baby is in extremis, the previous step is omitted and the cord is clamped immediately 6 cm from the umbilicus. 3. Delayed cord clamping plus milking of the contents of the cord The obstetrician or midwife holds the baby as low as possible below the level of the introitus or the placenta for 30 – 60 seconds then clamps the cord and cut long (3 cm from the placenta or the introitus) and hands the baby over to the neonatal team. If the baby is in extremis, the previous step is omitted and the cord is immediately clamped and cut long (3 cm from the placenta or the introitus). After the delay step, a neonatal team member untwists the cord and milks the cord into the baby during resuscitation.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Women considered to have a reasonable chance of delivering < 32 weeks of gestation. Also that informed consent has been received from a parent or legal guardian
Exclusion criteria
No indication or contraindication to placental transfusion, in view of mother or doctor.
Outcome results
None listed