| 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: not stated | |
| Participants | Location: University of Illinois, Chicago, USA Timeframe: not stated in manuscript, the study is coded as 1980s for the review Eligibility criteria: women with PROM and < 4 cm of cervical dilatation Gestational age range: 25‐32 weeks Exclusion criteria: infection, fetal distress, fetal anomalies, contraindication to tocolysis Total recruited: 45 women and infants; 23 women and infants in the treatment arm and 22 women and infants in the control arm | |
| Interventions | The treatment group received 2 doses of 12 mg betamethasone IM 12 h apart repeated weekly until 32 weeks. The control group received expectant management. | |
| Outcomes | Fetal/neonatal outcomes reported (fetal death, neonatal death, RDS, systemic infection in the first 48 h of life, proven neonatal infection while in NICU) | |
| Notes | ||
| 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 was not possible due to the nature of the comparison. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of outcome assessment was not described. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up or exclusions described |
| Selective reporting (reporting bias) | Low risk | Pre‐specified outcomes were reported. |
| Other bias | Unclear risk | Insufficient information to asses if other sources of bias exist. |