| 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: yes Losses to follow‐up: no Funding: FIS; Perinatal Section of SEGO | |
| Participants | Location: Hospital Clinic, University of Barcelona, Spain Timeframe: 1987‐1990 Eligibility criteria: women with PROM Gestational age range: 28‐30 weeks Exclusion criteria: none stated Total recruited: 18 women and infants; 12 women and infants in the treatment arm and 6 women and infants in the control arm | |
| Interventions | Type and dose of corticosteroid used in the treatment group is not stated Control group received expectant management | |
| Outcomes | Fetal/neonatal outcome reported (RDS) | |
| Notes | Study only available as an abstract. 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 | Blinding of outcome assessment was not stated |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up |
| Selective reporting (reporting bias) | Unclear risk | Study only available as an abstract |
| Other bias | Unclear risk | Study was only available as an abstract. Further information was requested from the study authors, but there was no reply |