The Australian Placental Transfusion Study (APTS): Should Very Pre Term Babies Receive a Placental Blood Transfusion at Birth Via Deferring Cord Clamping Versus Standard Cord Clamping Procedures?
APTS
A Randomised Two Arm Open Label Controlled Trial Comparing Standard Immediate Cord Clamping Versus Deferring Cord Clamping for 60 Seconds or More in Babies Born Less Than 30 Weeks of Gestation to Determine Which Cord Clamping Method Results in Improved Survival and Less Disability.
2 other identifiers
interventional
1,637
7 countries
26
Brief Summary
To establish if placental transfusion, using deferred cord clamping for 60 seconds or more while holding the baby at or below the level of the placenta, will improve survival without disability compared with standard early cord clamping in preterm babies less than 30 weeks of gestation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2010
Longer than P75 for not_applicable
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 8, 2015
CompletedFirst Posted
Study publicly available on registry
November 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedNovember 5, 2020
November 1, 2020
6.6 years
January 8, 2015
November 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Death and/or major morbidity at 36 weeks post menstrual age
Composite death and/or major morbidity at 36 completed weeks post menstrual age. Morbidity is defined by one or more of the following: brain injury on ultrasound, severe retinopathy, necrotising enterocolitis, late onset sepsis.
36 weeks post menstrual age
Secondary Outcomes (15)
Incidence of death
36 completed weeks post menstrual age
Incidence of major morbidity
36 completed weeks post menstrual age
Incidence of death or major disability
Up to 3 years corrected age
Incidence of death or brain injury on ultrasound
36 completed weeks post menstrual age
Major disability defined as cerebral palsy with an inability to walk unassisted, severe visual loss, deafness, major problems with language or speech, or a score indicative of developmental delay on Ages and Stages Questionnaire.
Up to 3 years corrected age
- +10 more secondary outcomes
Study Arms (2)
Early cord clamping (Control Arm)
NO INTERVENTIONImmediate cord clamping (\< 10 seconds after birth). The cord is clamped 6 cm from the umbilicus within ten seconds of delivery of the baby.
Deferred cord clamping
EXPERIMENTALDeferred cord clamping. Investigator/Research personnel holds the baby as low as possible below the level of the introitus or placenta for 60 seconds and not to exceed 80 seconds, then clamps the cord about 6 cm from the umbilicus.
Interventions
Deferred cord clamping (for 60 seconds or more with the baby held below or at the level of the placenta)
Eligibility Criteria
You may qualify if:
- Women who have a reasonable chance of delivering less than 30 weeks of gestation. Informed consent has been received from the parent or guardian.
You may not qualify if:
- No indication or contraindication to placental transfusion, in the view of mother or baby.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Sydneylead
- National Health and Medical Research Council, Australiacollaborator
- Baylor College of Medicinecollaborator
Study Sites (26)
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Vermont Medical Centre
Burlington, Vermont, 05401, United States
Canberra Hospital
Canberra, Australian Capital Territory, 2605, Australia
John Hunter Hospital
Newcastle, New South Wales, 2305, Australia
Liverpool Hospital
Sydney, New South Wales, 2031, Australia
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050, Australia
Royal North Shore Hospital
Sydney, New South Wales, 2065, Australia
Royal Hospital for Women
Sydney, New South Wales, 2170, Australia
Nepean Hospital
Sydney, New South Wales, 2747, Australia
Mater Mother's Hospital
Brisbane, Queensland, 4029, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4101, Australia
Townsville Hospital
Townsville, Queensland, 4814, Australia
Flinders Medical Centre
Adelaide, South Australia, 5042, Australia
Monash Medical Centre
Melbourne, Victoria, 3084, Australia
Mercy Hospital for Women
Melbourne, Victoria, 3168, Australia
King Edward Memorial Hospital
Perth, Western Australia, 6008, Australia
IWK Health Center
Halifax, Nova Scotia, B3K6BA, Canada
Hôpital Antoine-Béclère
Clamart, 92140, France
Auckland Hospital
Auckland, 1023, New Zealand
Christchurch Hospital
Christchurch, 4710, New Zealand
Dunedin Hospital
Dunedin, 9016, New Zealand
Waikato Hospital
Hamilton, 3204, New Zealand
Wellington Hospital
Wellington, 6021, New Zealand
Aga Khan University Hospital
Karachi, 74800, Pakistan
Royal Jubilee Maternity Hospital
Belfast, Northern Ireland, BT12 6BA, United Kingdom
Craigavon Area Hospital
Craigavon, Northern Ireland, BT63 5QQ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William T Mordi, MD
University of Sydney
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2015
First Posted
November 17, 2015
Study Start
September 1, 2010
Primary Completion
April 1, 2017
Study Completion
September 1, 2020
Last Updated
November 5, 2020
Record last verified: 2020-11