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. 2017 Mar 21;2017(3):CD004454. doi: 10.1002/14651858.CD004454.pub3
Methods Type of study: RCT (abstract) Method of treatment allocation: not described
Stratification: not described Placebo: yes, saline Sample size calculation: not stated Intention‐to‐treat analyses: not stated Losses to follow‐up: not stated Funding: not stated
Participants Location: Temple University Hospital, Philadelphia, Pennsylvania, USA Timeframe: July 1976‐July 1978 Eligibility criteria: any pregnant woman expected to deliver prior to 34 weeks' gestation between July 1976 and July 1978 at Department of Obs & Gyne at Temple University Hospital Gestational age range: prior to 34 weeks Exclusion criteria: not stated Total recruited: 45 placebo, 47 steroids
Interventions Treatment group received an IM injection of betamethasone. The control group received an IM injection of saline as placebo.
Outcomes Neonatal mortality, RDS
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not stated other than "randomized"
Allocation concealment (selection bias) Unclear risk Not stated
Blinding of participants and personnel (performance bias) All outcomes Low risk Likely that participants were blinded and possible that study personnel were blinded due to the use of placebo
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Blinding of outcome assessor not stated
Incomplete outcome data (attrition bias) All outcomes Unclear risk Not stated
Selective reporting (reporting bias) High risk RDS is the only outcome reported.
Other bias Unclear risk Only available as an abstract ‐ does not appear to have been published