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. 2017 Mar 21;2017(3):CD004454. doi: 10.1002/14651858.CD004454.pub3
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.