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. 2014 Aug 15;2014(8):CD001060. doi: 10.1002/14651858.CD001060.pub2

Fox 1993.

Methods Single‐centre RCT.
Participants 101 women, 90 consented.
 Inclusion criteria: in documented preterm labour eligible; gestational age range: between 34‐37 weeks.
 Exclusion criteria: women with cervical dilatation ≥ 3 cm, ruptured membranes, medical or obstetric complications necessitating delivery, suspected anomalies, maternal allergy to magnesium sulphate.
 Total recruited: 101 women, 45 to magnesium (vs) 45 to control group (conservative management).
Setting: Jackson, Mississippi, USA (timeframe not stated).
Interventions MAGNESIUM VS CONSERVATIVE MANAGEMENT 
 1) Magnesium sulphate (n = 45): loading dose 4 g IV as a bolus. Maintenance: 2‐4 g/hr until uterine quiescence obtained. Duration: after uterine quiescence oral magnesium until 37 weeks' gestation.
 2) Control group (n = 45): 'conservative management with hydration, sedation and observation'. 'Underwent an identical evaluation' however labour was allowed to continue.
Outcomes Interval from diagnosis to delivery; gestational age at time of delivery; adverse effects of therapy; maternal infections; birthweight; neonatal morbidity and mortality.
Serious infant outcome: able to be defined as perinatal mortality and IVH 3/4 and/or PVL.
Notes Antenatal corticosteroid use: "not used in any patient".
 Surfactant use: not stated.
Sample size calculation: stated but not a priori.
Funding: Vicksburg Hospital Medical Foundation.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "table of random numbers".
Allocation concealment (selection bias) Low risk "randomisation was performed by using the sealed‐envelope method in which the group selection was generated from a table of random numbers. A disinterested third party (the pharmacy) was in charge of selection of the envelope for each patient. The treating physicians did not have access to the envelopes".
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Women were not blinded as interventions were IV drug vs usual management. Researchers would not be blinded to interventions.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No details but unlikely.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No evidence of loss after randomisation and ITT analysis conducted.
Selective reporting (reporting bias) Low risk Outcomes appear to be appropriate and all were reported on.
Other bias Low risk No apparent evidence of other bias.