deferred cord clamping
ProcedureDeferred cord clamping (for 60 seconds or more with the baby held below or at the level of the placenta)
NCT Number: NCT02606058
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.
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Notify MeFemale
Interventional
Not applicable
Canberra Hospital, Canberra, Australian Capital Territory, Australia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Women who have a reasonable chance of delivering less than 30 weeks of gestation. Informed consent has been received from the parent or guardian.
Exclusion criteria
No indication or contraindication to placental transfusion, in the view of mother or baby.
Deferred cord clamping (for 60 seconds or more with the baby held below or at the level of the placenta)
Time frame: 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.
Time frame: 36 completed weeks post menstrual age
The death component of the composite primary outcome
Time frame: 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).
Time frame: 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)
Time frame: 36 completed weeks post menstrual age
Death or brain injury on ultrasound
Time frame: Up to 3 years corrected age
Time frame: 36 completed weeks post menstrual age
Time frame: 36 completed weeks post menstrual age
Time frame: 36 completed weeks post menstrual age
Time frame: 36 completed weeks post menstrual age
Time frame: 36 completed weeks post menstrual age
Time frame: 36 completed weeks post menstrual age
Time frame: 36 completed weeks post menstrual age
Time frame: 36 completed weeks post menstrual age
Time frame: 36 completed weeks post menstrual age
Time frame: Up to 3 years corrected age
University of Sydney
Other
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.
Acronym: APTS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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