Fekih 2002

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, number of post‐randomisation exclusions not stated Funding: not stated
Participants	Location: CHU Farhat Hached, Sousse, Tunisia Timeframe: January 1998‐June 1999 Eligibility criteria: women in preterm labour Gestational age range: 26‐34 weeks Exclusion criteria: gestational diabetes, > 4 cm cervical dilatation, fetal abnormalities, contraindication to corticosteroids, delivery elsewhere or after 34 weeks (post‐randomisation exclusions) Total recruited: 118 women and 131 infants; 59 women and 63 infants in the treatment arm and 59 women and 68 infants in the control arm
Interventions	Abstract and full report state slightly different protocols for the intervention arm. The abstract stated that 24 mg betamethasone was given as two 12 mg IM doses at 24 h apart. The full text states that this regimen was repeated weekly. Women had two doses of 12 mg given 24 h apart, and this regimen was repeated weekly. Control group received expectant management
Outcomes	Maternal outcomes (chorioamnionitis, postnatal fever) and fetal/neonatal outcomes reported (neonatal death, RDS, IVH)
Notes	Article in French, abstract in English. Article translated by review authors (La Tunisie Medicale, 2002, Vol 80; No. 5: 260‐265). 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 was not stated
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding is unlikely as placebo was not used
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Blinding of outcome assessors was not described
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Number of post‐randomisation exclusions not stated
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