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Trial registered on ANZCTR


Registration number
ACTRN12609000248268
Ethics application status
Approved
Date submitted
17/02/2009
Date registered
12/05/2009
Date last updated
5/07/2012
Type of registration
Prospectively registered

Titles & IDs
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.
Secondary ID [1] 262236 0
NA
Universal Trial Number (UTN)
Trial acronym
APTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre term birth 4341 0
Neonatal health 4342 0
Condition category
Condition code
Reproductive Health and Childbirth 4583 4583 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 4584 4584 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 4585 4585 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 4075 0
Other interventions
Comparator / control treatment
Immediate cord clamping (where the cord is clamped 6 cm from the umbilicus within ten seconds of delivery of the baby).
Control group
Active

Outcomes
Primary outcome [1] 5461 0
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
Timepoint [1] 5461 0
at 6 hours after birth
Secondary outcome [1] 9191 0
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
Timepoint [1] 9191 0
1 hour and 24 hours after birth
Secondary outcome [2] 9192 0
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
Timepoint [2] 9192 0
1 hour if available, and 24 hours after birth from baby
Secondary outcome [3] 9193 0
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
Timepoint [3] 9193 0
1, 6 and 24 hours after birth
Secondary outcome [4] 9194 0
Number and volume of blood transfusions
Timepoint [4] 9194 0
During hospital stay
Secondary outcome [5] 9195 0
Mortality
Timepoint [5] 9195 0
before discharge home
Secondary outcome [6] 9197 0
Morbidity (incidence of chronic lung disease, severe retinopathy, brain injury on ultrasound and necrotising enterocolitis)
Timepoint [6] 9197 0
During hospital stay
Secondary outcome [7] 9198 0
APGAR scores to summarise the health of the newborn child
Timepoint [7] 9198 0
1 and 5 minutes after birth

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No indication or contraindication to placental transfusion, in view of mother or doctor.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All mothers considered by the obstetric team to have a reasonable chance of delivering before 32 weeks will be consented. Randomisation will be completed by a member of the obstetric, midwifery or neonatal team. Central phone randomisation will be used. This is a computerised interactive voice response system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The computer generated randomisation lists used with the interactive voice response system will be prepared by an independent statistician at the NHMRC Clinical Trials Centre. The randomisation code will be stored securely by the statistical group at the centre.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1517 0
2065
Recruitment postcode(s) [2] 1518 0
2050
Recruitment postcode(s) [3] 1519 0
2145
Recruitment postcode(s) [4] 1520 0
2605

Funding & Sponsors
Funding source category [1] 4514 0
Government body
Name [1] 4514 0
National Health and Medical Research Councile (NHMRC) project grant
Address [1] 4514 0
GPO Box 1421
Canberra ACT 2601
Country [1] 4514 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Locked Bag 77
Camperdown NSW 1450
Country
Australia
Secondary sponsor category [1] 4082 0
None
Name [1] 4082 0
Address [1] 4082 0
Country [1] 4082 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6939 0
Northern Sydney Central Coast
Ethics committee address [1] 6939 0
Level 2, Building 51
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 6939 0
Australia
Date submitted for ethics approval [1] 6939 0
Approval date [1] 6939 0
16/04/2009
Ethics approval number [1] 6939 0
EC00132

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29299 0
Address 29299 0
Country 29299 0
Phone 29299 0
Fax 29299 0
Email 29299 0
Contact person for public queries
Name 12546 0
Dr Lucille Sebastian
Address 12546 0
Locked Bag 77
Camperdown NSW 1450
Country 12546 0
Australia
Phone 12546 0
+ 61 2 9562 5335
Fax 12546 0
+61 2 9565 1863
Email 12546 0
apts@ctc.usyd.edu
Contact person for scientific queries
Name 3474 0
Professor William Tarnow-Mordi
Address 3474 0
PO Box 533
WENTWORTHVILLE
NSW 2145
Country 3474 0
Australia
Phone 3474 0
+ 61 2 9845 8900
Fax 3474 0
+ 61 2 9804 1660
Email 3474 0
Williamtm@med.usyd.edu.au

No information has been provided regarding IPD availability
Summary results
No Results