Taeusch 1979

Methods	Type of study: RCT Method of treatment allocation: method of randomisation not stated. Coded drug boxes used Stratification: yes, by gestational age at entry Placebo: yes, normal saline Sample size calculation: yes Intention‐to‐treat analyses: no Losses to follow‐up: yes, data not available for maternal outcomes on 4 women (2 in each treatment arm) Funding: not stated
Participants	Location: 2 hospitals in Boston, USA Timeframe: January 1975‐March 1977 Eligibility criteria: women with preterm labour, PROM or with cervical dilatation < 5 cm at 33 weeks or less and women with an L/S ratio < 2 if > 33 weeks or who had a previous infant with RDS Gestational age range: not stated Exclusion criteria: indication for immediate delivery, obstetrician objection, pre‐eclampsia, previously received corticosteroids Total recruited: 122 women and 127 infants recruited; 39 women and 54 infants randomised to the treatment arm and 36 women and 42 infants randomised to the control arm
Interventions	The treatment group received 6 doses of 4 mg dexamethasone phosphate IM 8 h apart. The control group received placebo.
Outcomes	Maternal outcomes (endometritis, fever after trial entry requiring antibiotics) and fetal/neonatal outcomes reported (fetal death, neonatal death, RDS, chronic lung disease, IVH, proven neonatal infection while in NICU)
Notes	Study authors contacted for further information but there was no reply
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	Coded drug boxes were used, but it is not clear how they were coded, e.g. if they were sequentially numbered.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	It is likely that participants were blinded due to the use of an identical looking placebo. Blinding of study personnel was not described.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Diagnosis of RDS was made prior to breaking the treatment code.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Data not available for maternal outcomes on 4 (3%) women (2 in each treatment arm) with no explanation given.
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.