None listed
Conditions
Brief summary
Birth by planned caesarean section poses some risk to babies, in particular, the need for admission to the neonatal unit for breathing support. Corticosteroid injections given to mothers expecting a preterm birth reduce neonatal respiratory morbidity but is not known if corticosteroids before a planned caesarean section at or near term have the same effect. Limited research suggests that as well as benefits on babies’ breathing these injections may lower babies’ blood sugar levels and so possibly cause harm. The C*STEROID Trial is a multi-centre, placebo-controlled, randomised trial to assess the effects of corticosteroids given to mothers before a planned caesarean section at or near term on neonatal and childhood health.
Interventions
Two doses of 11.4mg betamethasone by intramuscular injection into the thigh, arm or buttock, 24 hours apart given within seven days of planned caesarean section. Adherence will be assessed by review of the drug accountability log and/or medication chart.
Sponsors
The University of Auckland
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
Healthy volunteers
No
Inclusion criteria
1. Women for whom caesarean section is planned pre-labour at 35+0 to 39+6 weeks gestation. 2. >24 hours and <7 days before planned birth. 3. Singleton or twin pregnancy with a live fetus.
Exclusion criteria
1. Diabetes: pre-existing or gestational. 2. Major fetal abnormality. 3. Prior corticosteroid use in this pregnancy (intramuscular corticosteroid use for fetal lung maturity). 4. Prior enrolment in the C*STEROID Feasibility Study or C*STEROID Trial, in a previous pregnancy.
Outcome results
None listed