Lewis 1996

Methods	Type of study: RCT Method of treatment allocation: random‐number table generated randomisation sequence by clinical research nurse uninvolved in clinical care. Sequentially‐numbered sealed opaque envelopes used. Stratification: none stated Placebo: no Sample size calculation: no Intention‐to‐treat analyses: no Losses to follow‐up: yes, 2 (2%) women left hospital after randomisation and were lost to follow‐up (1 woman in each arm) Funding: not stated
Participants	Location: Louisiana State University Medical Center, Shreveport, Louisiana, USA Timeframe: not stated in manuscript, the study is coded as 1990s for the review Eligibility criteria: women with singleton pregnancies with PROM. Women were randomised 12‐24 h after receiving IV ampicillin‐sulbactam Gestational age range: 24‐34 weeks Exclusion criteria: evidence of infection, vaginal examination, cerclage, allergic to penicillin, contraindication to expectant management, lung maturity confirmed by L/S ratio if 32 weeks or more Total recruited: 79 women and infants; 39 women and infants in the treatment arm and 40 women and infants in the control arm
Interventions	The treatment group received 12 mg IM betamethasone repeated at 24 h and weekly if the women had not delivered. The control group received expectant management.
Outcomes	Maternal outcomes (chorioamnionitis, endometritis), fetal/neonatal outcomes (neonatal death, RDS, IVH, birthweight, Apgar < 7, interval between trial entry and delivery, admission to NICU, surfactant use, proven neonatal infection while in NICU, necrotising enterocolitis) and health service outcome reported (length of neonatal hospitalisation)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Clinical research nurse uninvolved in clinical care generated randomisation sequence by using random‐number table, with a random permuted block size of 10
Allocation concealment (selection bias)	Low risk	Sequentially‐numbered sealed opaque envelopes were used
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comparison was "no treatment" so blinding not possible
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Blinding of outcome assessors was not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	2 (2%) women left hospital against medical advice after randomisation and were lost to follow‐up (1 women in each arm)
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