Silver 1996

Methods	Type of study: RCT Method of treatment allocation: computer‐generated randomisation sequence used Pharmacy provided identical syringes labelled with the woman's study number. Stratification: none stated Placebo: yes, normal saline Sample size calculation: yes Intention‐to‐treat analyses: no Losses to follow‐up: 124 women initially recruited, of whom 49 (40%) remained undelivered after 29 weeks and were not included in the review Funding: not stated
Participants	Location: Northwestern University Medical School, Chicago, Illinois, USA Timeframe: April 1990‐June 1994 Eligibility criteria: women at risk of delivery between 24‐29 weeks Gestational age range: 24‐29 weeks Exclusion criteria: infection, maternal or fetal indications for urgent delivery Total recruited: 75 women and 96 infants; 39 women and 54 infants in the treatment arm and 36 women and 42 infants in the control arm
Interventions	The treatment group received 4 doses of 5 mg dexamethasone IM 12 h apart, repeated weekly if the women remained undelivered. The control group received placebo. All infants born < 30 weeks received prophylactic surfactant at birth.
Outcomes	Maternal outcomes (chorioamnionitis, endometritis) and fetal/neonatal outcomes reported (neonatal death, RDS, chronic lung disease, IVH, small‐for‐gestational age, birthweight, necrotising enterocolitis)
Notes	Those women undelivered after 29 weeks were eligible for corticosteroid outside the study protocol. These women and their infants are not included in the review as it was not possible to separate out control women who subsequently received corticosteroids
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation sequence used
Allocation concealment (selection bias)	Low risk	Pharmacy provided identical syringes labelled with the woman's study number.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"Clinical personnel and the patient were effectively blinded to study group assignment"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The severity of RDS, and diagnosis of IVH were "confirmed independently by chart reviews conducted by 1 of the authors blinded to study group assignment"
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	49 (40%) of the 124 women initially recruited, remained undelivered after 29 weeks and were not included in the review.
Selective reporting (reporting bias)	Low risk	Study protocol not available, but appears to report on all pre‐specified outcomes
Other bias	Unclear risk	Insufficient information to asses if other sources of bias exist.