Associate Professor Joanne Said success in MRFF grant.
We are very pleased to share the exciting news that Associate Professor Joanne Said and her collaborators have been awarded over $2M funding through the MFRR International Clinical Trials Collaborations initiative for the C*STEROID trial. The New Zealand arm of the trial has already commenced recruitment under the leadership of Associate Professor Katie Groom. Recruitment will commence at over 10 Australian sites later this year.
Controversy has surrounded the use of corticosteroids prior to planned elective caesarean section in the late preterm and term period for some time.1 Current Australian guidelines recommend the use of corticosteroids when preterm birth is expected (prior to 34+6 weeks).2 Although some trials have suggested beneficial effects of corticosteroids when given prior to planned caesarean section3, concerns have been raised about the methodology of some of these trials4. Moreover, recent studies have suggested the potential for risks such as neonatal hypoglycaemia5 or longer term neurocognitive or behavioural consequences in the children following exposure to antenatal corticosteroids.6, 7
C*STEROID is an international, randomised placebo-controlled trial to determine the effect of antenatal corticosteroids on newborn health when given prior to planned caesarean section birth. If proven to be safe and efficacious, this simple intervention has the potential for rapid implementation in Australia, with benefits to the increasing number of babies born by planned caesarean section each year, including reductions in neonatal nursery admissions and improvements in maternal bonding and breastfeeding rates.
Inclusion Criteria:
| Exclusion Criteria:
|
* Planned pre-labour CS ≥35+0 – 39+6 weeks gestation | * Diabetes (pre-existing or gestational)* |
* ≥24 hours and <7 days until planned birth * Singleton or twin pregnancy with a live fetus | * Major fetal abnormality * Prior corticosteroid use in this pregnancy (intramuscular corticosteroid use for fetal lung maturity) |
*Note that women with diabetes will not be eligible for the C*STEROID trial. They remain eligible for the PRECeDe Pilot trial but we will launch the international multicentre PRECeDe Trial specifically for women with diabetes in 2022.