Australian Placental Transfusion Pilot Study: investigating standard cord clamping procedures versus three methods of autologous placental blood transfusion in pre term infants.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12609000248268
• Date of registration: 12/05/2009
• Prospective Registration: Yes
• Primary sponsor: University of Sydney
• Public title: Australian Placental Transfusion Pilot Study: investigating standard cord clamping procedures versus three methods of autologous placental blood transfusion in pre term infants.
• Scientific title: Which method of placental transfusion should very preterm babies receive at birth? A randomised controlled trial four arm pilot study comparing methods of placental transfusion with standard immediate cord clamping to determine which placental transfusion method delivers the greatest increase in blood volume.
• Date of first enrolment: 02/06/2009
• Target sample size: 100
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12609000248268.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Lucille Sebastian

• Name: Professor William Tarnow-Mordi

Key inclusion & exclusion criteria

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.

Age minimum: No limit
Age maximum: No limit
Gender: Females

Health Condition(s) or Problem(s) studied

Reproductive Health and Childbirth - Childbirth and postnatal care

Pre term birth;Neonatal health;
Pre term birth
Neonatal health

Reproductive Health and Childbirth - Complications of newborn

Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

Intervention(s)

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.

Primary Outcome(s)

Haemoglobin concentration will be measured using arterial or venous or capillary blood on the neonatal intensive care unit blood gas analysis machine or hospital laboratory using any method pragmatically available[at 6 hours after birth]

Secondary Outcome(s)

APGAR scores to summarise the health of the newborn child[1 and 5 minutes after birth]

Absolute change in haematocrit between baseline (from placenta at birth). Haematocrit will be measured using arterial or venous or capillary blood on the neonatal intensive care unit blood gas analysis machine or hospital laboratory using any method pragmatically available[1, 6 and 24 hours after birth]

Absolute change in haemoglobin concentration between baseline (from placenta at birth). Haemoglobin concentration will be measured using arterial or venous or capillary blood on the neonatal intensive care unit blood gas analysis machine or hospital laboratory using any method pragmatically available[1 hour if available, and 24 hours after birth from baby]

Morbidity (incidence of chronic lung disease, severe retinopathy, brain injury on ultrasound and necrotising enterocolitis)[During hospital stay]

Mortality[before discharge home]

Haemoglobin concentration will be measured using arterial or venous or capillary blood on the neonatal intensive care unit blood gas analysis machine or hospital laboratory using any method pragmatically available[1 hour and 24 hours after birth]

Number and volume of blood transfusions[During hospital stay]

Source(s) of Monetary Support

National Health and Medical Research Councile (NHMRC) project grant

Ethics review

Status: Approved
Approval date:
Contact:

Northern Sydney Central Coast