Steroids before elective CS at term (ASTECS trial) Flashcards
What was the aim of this study?
To see if antenatal corticosteroids reduce respiratory distress in babies born by elective CS at term.
What type of study was this?
Multicentre PRAGMATIC RCT. Participants and health professionals were not blinded.
What was the inclusion criteria for this trial?
Planned elective CS at or after 37 weeks.
What was the exclusion criteria for this trial?
Exclusion criteria:
- Severe maternal HTN
- Severe fetal Rh sensitisation.
- Peptic ulcer disease history
- Intrauterine infection
Describe the study groups and method:
Treatment group 503: received two doses of IM betamethasone 12mg 48 hours before elective CS.
Control group 495: received usual care without steroids. (NO placebo = UNBLINDED)
Algorithm used to ensure participants were accurately dated.
Intention to treat analysis.
What were the primary outcomes measured?
Primary outcome:
- Admission to SCBU with respiratory distress.
What were the secondary outcomes measured?
Secondary outcomes:
- Level of care required.
- Severity of respiratory distress.
What were the main results and conclusions of the study?
Results:
- Significant reduction in admission to SCBU for respiratory distress for steroid group RR 0.46.
- Rates of admission to SCBU fell with increasing gestational age.
- Lower incidence of RDS (RR 0.21) and TTN (RR 0.54) i the steroid group.
Conclusions:
- Antenatal betamethasone and delaying delivery until 39 weeks both reduce admissions to SCBU with respiratory distress after elective CS at term by >50%.
What were the strengths and weaknesses of this trial?
Strengths:
- Similar characteristics between tx and control grp.
Weaknesses:
- Lacked power to detect effect of race