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?
- Conditions
- Preterm Birth
- Interventions
- Procedure: Deferred cord clamping
- Registration Number
- NCT02606058
- Lead Sponsor
- University of Sydney
- 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.
- Detailed Description
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 delaying the clamping of the umbilical cord by 60 seconds or more. There is promising evidence from randomised trials that placental transfusion in babies less than 37 weeks of pregnancy may improve their blood pressure, reduce the number of blood transfusions needed and decrease bleeding into the brain, bowel disease and infection. However, we 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 very preterm babies are given a placental transfusion at birth. It is important to find out if placental transfusion does more good than harm, before it becomes even more widely used.
The Australian Placental Transfusion Study will enrol at least 1600 women who will give birth to babies born less than 30 weeks of gestation. These participants will be randomly assigned to either standard treatment where the umbilical cord is clamped within 10 seconds of birth or a second method where the umbilical cord will be clamped after waiting for 60 seconds or more at birth while the baby is being held below the level of the placenta. The main research question is whether placental transfusion reduces death and disability when the baby is discharged from hospital and into childhood.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1637
Women who have a reasonable chance of delivering less than 30 weeks of gestation. Informed consent has been received from the parent or guardian.
No indication or contraindication to placental transfusion, in the view of mother or baby.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Deferred cord clamping Deferred cord clamping Deferred 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.
- Primary Outcome Measures
Name Time Method Death and/or major morbidity at 36 weeks post menstrual age 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.
- Secondary Outcome Measures
Name Time Method IVH (all grades) seen on ultrasound 36 completed weeks post menstrual age IVH (Grades 3 & 4) seen on ultrasound 36 completed weeks post menstrual age Incidence of death or major disability Up to 3 years corrected age Death or major disability (for example cerebral palsy with inability to walk; blindness; deafness; major problems with language or speech; ASQ score indicative of developmental delay)
Incidence of death or brain injury on ultrasound 36 completed weeks post menstrual age Death or brain injury on ultrasound
Incidence of major morbidity 36 completed weeks post menstrual age Major morbidity (incidence of one or more of brain injury on ultrasound, severe retinopathy, necrotising enterocolitis or late onset sepsis).
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 Brain injury on ultrasound 36 completed weeks post menstrual age Incidence of death 36 completed weeks post menstrual age The death component of the composite primary outcome
IVH (Grade 4) seen on ultrasound 36 completed weeks post menstrual age Severe retinopathy warranting treatment or Stage 4 retinopathy according to the Australian and New Zealand Neonatal Network (ANZNN) definitions 36 completed weeks post menstrual age Necrotizing enterocolitis with the following signs: at least 1 systemic sign, profile consistent with definite NEC, warranted treatment for NEC. 36 completed weeks post menstrual age Patent ductus arteriosis requiring treatment (documented in medical records) 36 completed weeks post menstrual age Chronic lung disease, defined as receiving supplemental oxygen or any form of assisted ventilation at 36 completed weeks post menstrual age for 4 consecutive hours in a 24 hour period 36 completed weeks post menstrual age Death up to 3 years corrected age Up to 3 years corrected age Late onset sepsis, defined as a clinical picture consistent with sepsis, and either a positive culture of blood and/or CSF, or a positive urine culture by sterile collection, and at least 5 days of antibiotic treatment. 36 completed weeks post menstrual age
Trial Locations
- Locations (26)
University of Vermont Medical Centre
🇺🇸Burlington, Vermont, United States
Royal Hospital for Women
🇦🇺Sydney, New South Wales, Australia
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Liverpool Hospital
🇦🇺Sydney, New South Wales, Australia
Canberra Hospital
🇦🇺Canberra, Australian Capital Territory, Australia
John Hunter Hospital
🇦🇺Newcastle, New South Wales, Australia
Royal North Shore Hospital
🇦🇺Sydney, New South Wales, Australia
Royal Prince Alfred Hospital
🇦🇺Sydney, New South Wales, Australia
Mater Mother's Hospital
🇦🇺Brisbane, Queensland, Australia
Nepean Hospital
🇦🇺Sydney, New South Wales, Australia
Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Queensland, Australia
Townsville Hospital
🇦🇺Townsville, Queensland, Australia
Flinders Medical Centre
🇦🇺Adelaide, South Australia, Australia
Hôpital Antoine-Béclère
🇫🇷Clamart, France
IWK Health Center
🇨🇦Halifax, Nova Scotia, Canada
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Auckland Hospital
🇳🇿Auckland, New Zealand
Waikato Hospital
🇳🇿Hamilton, New Zealand
Dunedin Hospital
🇳🇿Dunedin, New Zealand
Wellington Hospital
🇳🇿Wellington, New Zealand
Craigavon Area Hospital
🇬🇧Craigavon, Northern Ireland, United Kingdom
Royal Jubilee Maternity Hospital
🇬🇧Belfast, Northern Ireland, United Kingdom
King Edward Memorial Hospital
🇦🇺Perth, Western Australia, Australia
Mercy Hospital for Women
🇦🇺Melbourne, Victoria, Australia
Aga Khan University Hospital
🇵🇰Karachi, Pakistan
Monash Medical Centre
🇦🇺Melbourne, Victoria, Australia