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). |
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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. |
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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. |
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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. |