Armson 1992.
Methods | 2‐centre RCT. | |
Participants | 15 women.
Inclusion criteria: in preterm labour. Gestational age range: between 27‐36 weeks' gestation.
Exclusion criteria: women with obstetric or medical contraindications to tocolysis. Setting: Pennsylvania, USA (timeframe not stated). |
|
Interventions | MAGNESIUM VS BETAMIMETICS 1) magnesium sulphate (n = 8): loading dose 6 g IV MgSO4 over 30 minutes. Maintenance at 2 g/hr. Increased by 0.5 g/hr every 30 minutes until tocolysis achieved, a maximum of 4 g/hr attained or unacceptable side effects; 2) ritodrine (n = 7): loading dose 50 μg/min. Maintenance: increased by 50 μg/min at 15 minute intervals until tocolysis attained, a maximum of 350 μg/min, or unacceptable side effects. Duration: if tocolysis was successful the infusion rate was maintained at the lowest effective dose for 12 hrs. | |
Outcomes | Fetal and maternal deaths, birth within 12 hrs, and maternal cardiovascular and respiratory effects. | |
Notes | Antenatal corticosteroid use: 'were not given'.
Surfactant use: not stated. Sample‐size calculation: not stated. Funding: not stated. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "patients were prospectively randomised with a random number table." |
Allocation concealment (selection bias) | Unclear risk | No details provided. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No details provided, but blinding unlikely due to the nature of the intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details provided. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Women were excluded if they progressed to preterm birth in spite of maximum therapy or who had adverse side effects necessitating discontinuation of therapy. 1 woman treated with MgSO4 progressed to birth in spite of maximum therapy and was therefore excluded from the study. |
Selective reporting (reporting bias) | Unclear risk | Not all expected outcomes were reported. |
Other bias | Low risk | No apparent evidence of other bias. |