Shanks 2010

Methods	Type of study: RCT Method of treatment allocation: not stated other than "randomly assigned" Stratification: not stated Placebo: no Sample size calculation: yes Intention‐to‐treat analyses: no Losses to follow‐up: 7 (22%) women (3 in the study group and 4 in the control group) delivered within 7 d of their initial testing for fetal lung maturity and were excluded from the analysis Funding: supported in part by a Clinical and Translational Science Award, and by a grant from the National Centre for Research Resources, a component of the National Institute of Health and NIH Roadmap for Medical Research
Participants	Location: Barnes‐Jewish Hospital, St Louis, Missouri, USA Timeframe: May 2003‐May 2008 Eligibility criteria: singleton gestation, between 34 + 0 and 36 + 6 weeks' gestation, immature TDx‐FLM‐II test (< 45 mg/g) (this test measures surfactant to albumin ratio) after clinically indicated amniocentesis to test for fetal lung maturity. Gestational age range: 34 + 0 ‐36 + 6 weeks' gestation Exclusion criteria: multiple gestations, ruptured membranes, uncertain gestational ages, previous steroid treatment in current pregnancy, delivery before completing the steroid course, those unwilling or unable to comply with study protocol Total recruited: 32 women and infants; 13 women and infants in the treatment arm and 19 women and infants in the control arm
Interventions	The treatment group received either 2 doses of betamethasone 12 mg IM 24 h apart, or 4 doses of dexamethasone 6 mg IM 12 h apart. The control group received no treatment.
Outcomes	Maternal outcomes (side effects of therapy in women) and fetal/neonatal outcomes (need for mechanical ventilation/CPAP, admission to NICU)
Notes	This study was stopped early due to difficulties in participant recruitment
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Randomly assigned" not further described
Allocation concealment (selection bias)	Unclear risk	"Sealed envelopes" not further described
Blinding of participants and personnel (performance bias) All outcomes	High risk	Control group received no treatment so blinding of participants and study personnel would not have been possible
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No mention is made of blinding of outcome assessors
Incomplete outcome data (attrition bias) All outcomes	High risk	7 (22%) women (3 in the study group and 4 in the control group) delivered within 7 d of their initial testing for fetal lung maturity and were excluded from the analysis. No intention‐to‐treat analysis
Selective reporting (reporting bias)	High risk	Hyaline membrane disease is listed as an outcome, but not reported
Other bias	High risk	This study was stopped early due to difficulties in patient recruitment