Balci 2010

Methods	Type of study: RCT Method of treatment allocation: computer‐generated random number table, sequential sealed envelopes, not stated if opaque Stratification: none stated Placebo: no, comparison was no treatment Sample size calculation: not stated Intention‐to‐treat analyses: yes Losses to follow‐up: 30 infants with fetal distress, meconium‐stained liquor and who delivered within less than 24 h were excluded from the study (14 in control group, 16 in steroid group) Funding: not stated
Participants	Location: Dept of Obstetrics and Gynecology, Hospital of Meram, Faculty of Medicine, Selcuk University, Konya, Turkey Timeframe: January 2007 and May 2009. Eligibility criteria: 34‐36 weeks' gestation based on LMP. If unsure dates, fetal biometric measurements of 33‐36 weeks on abdominal ultrasonography (done on admission). The mother had had at least 2 contractions lasting more than 30 seconds in 10 min on cardiotocography, and cervical dilatation > 3 cm with 80% effacement Gestational age range: 34 + 0‐36 + 0 weeks Exclusion criteria: obstetric complications (severe IUGR, pre‐eclampsia, placental abruption, placenta praevia), multiple pregnancies, those who had already received antenatal corticosteroid therapy, PROM, or suspicion of chorioamnionitis, fetal anomaly, fetal distress, severe systemic disease (heart disease, hyperthyroidism, hypothyroidism, renal disease, diabetes mellitus) Total recruited: 100 (50 women and babies in each group)
Interventions	The treatment group received a single dose of 12 mg betamethasone IM. The control group received no treatment. Women who delivered at least 24 h after betamethasone administration were included in the study.
Outcomes	Apgar score at 1 and 5 minutes, need for resuscitation, development of RDS
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Generated by a computer"
Allocation concealment (selection bias)	Unclear risk	"Sequential sealed envelopes" not stated if opaque or not
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to comparison group receiving no treatment and treatment group receiving corticosteroids, blinding of participants and personnel would not have been possible.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Blinding of outcome assessors is not described.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	30 infants with fetal distress, meconium‐stained liquor and who delivered within less than 24 h were excluded from the study (14 in control group, 16 in steroid group). Intention‐to‐treat analysis was used
Selective reporting (reporting bias)	High risk	Maternal complications were not pre‐specified but were reported
Other bias	Unclear risk	Insufficient information to asses if other sources of bias exist.