Amorim 1999

Methods	Type of study: RCT Method of treatment allocation: computer‐generated randomisation sequence with randomisation code kept by the chief pharmacist. The pharmacy provided coded drug boxes. Stratification: none stated Placebo: yes, same volume of similar appearing vehicle Sample size calculation: yes Intention‐to‐treat analyses: no Losses to follow‐up: yes, 2 (1%) women in the placebo group dropped out after randomisation Funding: Instituto Materno‐Infantil de Pernambuco, Brazil
Participants	Location: Instituto Materno‐Infantil de Pernambuco, Recife, state of Pernambuco, Brazil Timeframe: April 1997‐June 1998 Eligibility criteria: women with severe pre‐eclampsia, singleton pregnancy with a live fetus and gestational age between 26‐34 weeks. Likely minimal interval of 24 h between drug administration and delivery. Lung immaturity was confirmed by the foam test in fetuses of 30‐34 weeks. Gestational age range: 26‐34 weeks Exclusion criteria: indication for immediate delivery, diabetes, PROM, maternal disease, congenital malformations, perinatal haemolytic disease, Group B streptococcal infection Total recruited: 220 women and infants. 110 women and infants in each arm
Interventions	12 mg betamethasone IM, repeated after 24 h and weekly thereafter if delivery had not occurred. Control group received identical placebo. Delivery was at 34 weeks or in the presence of maternal or fetal compromise in both groups.
Outcomes	Maternal outcomes (death, chorioamnionitis, maternal infection, fever after trial entry requiring antibiotics, intrapartum fever requiring antibiotics, postnatal fever, admission to ICU, glucose intolerance, hypertension), fetal/neonatal outcomes (fetal death, neonatal death, RDS, chronic lung disease, IVH, birthweight, Apgar score < 7, interval between trial entry and delivery, small‐for‐gestational age, admission to NICU, need for mechanical ventilation/CPAP, duration of oxygen supplementation, surfactant use, systemic infection in the first 48 h of life, proven infection while in the NICU, necrotising enterocolitis), childhood outcomes (death, developmental delay, cerebral palsy) and health service outcomes reported (length of antenatal hospitalisation for women, length of postnatal hospitalisation for women, length of neonatal hospitalisation)
Notes	Further information obtained from the study authors, including substantial unpublished data
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Computer‐generated randomisation sequence."
Allocation concealment (selection bias)	Low risk	"Randomisation code kept by the chief pharmacist."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Participants and investigators were blinded.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Blinding of outcome assessors was not described, but it is likely as the authors state, "the data analysis was carried out without knowledge of which of the treatments corresponded to corticosteroid and which to placebo". The code was fully broken only after the analysis was completed.
Incomplete outcome data (attrition bias) All outcomes	Low risk	2 women (1%) in the placebo group voluntarily dropped out after randomisation.
Selective reporting (reporting bias)	Low risk	Study protocol was not available, but study appears to report on all pre‐specified outcomes
Other bias	Low risk	The groups were comparable at baseline. The study appears free of other sources of bias.