Gamsu 1989

Methods	Type of study: RCT Method of treatment allocation: method of randomisation not stated. Stratification: yes, by hospital Placebo: yes, vehicle of betamethasone preparation Sample size calculation: no Intention‐to‐treat analyses: yes Losses to follow‐up: no Funding: Glaxo Group Research Ltd, Greenford, Middlesex, UK
Participants	Location: 11 hospitals in the UK Timeframe: mid 1975‐February 1978 Eligibility criteria: women with spontaneous or planned preterm delivery Gestational age range: < 34 weeks Exclusion criteria: contraindication to corticosteroids, contraindications to postponing delivery, diabetes, suspected intrauterine infection Total recruited: 251 women and 268 infants; 126 women and 131 infants in the treatment arm and 125 women and 137 infants in the control arm
Interventions	6 doses of 4 mg betamethasone phosphate IM 8 h apart Control group received 6 doses of placebo All women with spontaneous labour received IV salbutamol
Outcomes	Fetal/neonatal outcomes reported (fetal death, neonatal death, RDS, IVH, birthweight, systemic infection in the first 48 h of life)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Method of randomisation not stated
Allocation concealment (selection bias)	Unclear risk	Method of allocation concealment not stated
Blinding of participants and personnel (performance bias) All outcomes	Low risk	It is likely that participants were blinded as placebo was used. Blinding of study personnel was not described other than "double‐blind".
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Blinding of outcome assessors was not stated.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No losses to follow‐up reported
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