Carlan 1991

Methods	Type of study: RCT Method of treatment allocation: method of randomisation not stated. Stratification: none stated Placebo: no Sample size calculation: no Intention‐to‐treat analyses: no Losses to follow‐up: yes, 2 (8%) infants with documented pulmonary maturity and 5 (17%) women with subsequent sealed membranes were not analysed Funding: not stated
Participants	Location: University of South Florida Medical School, Tampa, Florida, USA Timeframe: not stated in manuscript, the study is coded as 1990s for the review Eligibility criteria: women with PROM Gestational age range: 24‐34 weeks Exclusion criteria: not stated Total recruited: the number randomised to each group is not stated. Data are available on 24 women and infants; 13 women and infants in the treatment arm and 11 women and infants in the control arm
Interventions	12 mg betamethasone IM repeated after 24 h and weekly thereafter until delivery or 34 weeks. Control group received expectant management.
Outcomes	Maternal outcome (chorioamnionitis), fetal/neonatal outcomes (RDS, birthweight, days of mechanical ventilation/CPAP) and health service outcomes reported (days in NICU, neonatal days in hospital, neonatal hospital cost). However due to lack of SD data only chorioamnionitis and RDS data were included in the review.
Notes	This study included a third arm (12 mg betamethasone IM 24‐hourly for 2 doses and 400 mcg methylprednisolone IV 8‐hourly for 6 doses, repeated weekly until delivery or 34 weeks. The data for the review report the betamethasone and control arms only. Further information was requested from the study authors 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	Method of allocation concealment not stated
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding of participants and personnel not stated, although unlikely as placebo was not used
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	Low risk	2 (8%) infants with documented pulmonary maturity and 5 (17%) women with subsequent sealed membranes were not analysed
Selective reporting (reporting bias)	Unclear risk	SD data not stated so a number of outcomes are not able to be included in the review
Other bias	Unclear risk	Only available as an abstract. Full paper not published