None listed
Conditions
Brief summary
Administration of antenatal corticosteroids to women prior to preterm birth has been one of the greatest success stories of modern pregnancy and newborn care. Multiple studies have demonstrated a reduction in the rate of breathing problems in newborn babies after this treatment. More recently, several studies have reported benefits when antenatal corticosteroids are given to women who give birth by elective caesarean section after 35 weeks. Elective CS, as opposed to vaginal birth (or even CS in labour) is associated with greater risks of breathing problems in newborn infants and this results in longer hospital stays and separation from the mother. Women with diabetes were specifically excluded from the studies that have demonstrated improvements in the rate of newborn breathing problems, hence, whether these benefits are the same for infants born to women with diabetes is uncertain. Further research in the subgroup of women with diabetes during pregnancy is urgently needed.
Interventions
11.4mg of Celestone Chronodose in 2ml (betamethasone 11.4mg as betamethasone sodium phosphate and betamethasone acetate)
2 injections will be administered intramuscularly, 24 hours apart, within 7 days prior to elective caesarean section, to participants randomised to receive investigational product.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Women with a singleton or twin pregnancy between 35+0 and 39+6 weeks gestation who have pre-gestational diabetes OR gestational diabetes (diagnosed on a pregnancy 75g Oral glucose tolerance test according to the WHO criteria for gestational diabetes OR the ADIPS revised criteria during the COVID pandemic) AND plan to give birth by planned caesarean section within the next 7 days.
Exclusion criteria
Known major fetal anomaly or chromosomal anomaly. Administration of intramuscular antenatal corticosteroids for the purposes of fetal lung maturation at any stage during the current pregnancy. Thrombocytopaenia with a platelet count below 80x109 /litre Hypersensitivity to betamethasone sodium phosphate, betamethasone acetate, or other corticosteroids received any corticosteroids at any time during the pregnancy Systemic fungal infection Contraindication to corticosteroids Previous participation in the PRECeDe trial (in a previous pregnancy). Note that participation in the PRECeDe pilot Trial is not regarded as an exclusion from participation in the current trial).
Outcome results
None listed