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?
Status: | Active, not recruiting |
---|---|
Conditions: | Women's Studies |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | Any |
Updated: | 5/4/2018 |
Start Date: | September 2010 |
End Date: | January 2020 |
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.
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.
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.
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.
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.
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.
We found this trial at
2
sites
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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