Davies 2006.
Study characteristics | ||
Methods | RCT | |
Participants | 70 women Inclusion criteria: ASA physical status I or II, women scheduled for elective CS under spinal anaesthesia, > 37 weeks' gestation Exclusion criteria: pregnancy‐induced hypertension, multiple pregnancy, fetal compromise, diabetes mellitus, polyhydramnios, weight > 100 kg, renal or hepatic disease, anaemia (haemoglobin < 10 g/dL), clotting Setting: UK |
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Interventions |
Colloid: 5 mL/kg versus 10 mL/kg preload Group 1: 5 mL/kg pentastarch, volume preload before spinal anaesthesia (infused over 10 min) Group 2: 10 mL/kg pentastarch, volume preload before spinal anaesthesia (infused over 10 min) All women received standardised aspiration prophylaxis, a standardised spinal anaesthetic technique and dose, and standardised positioning. Hypotension requiring intervention was treated with 6 mg increments of ephedrine until resolution; smaller decreases in BP were similarly treated if accompanied by nausea, vomiting or dizziness. |
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Outcomes |
Maternal: hypotension; ephedrine use Neonatal: Apgar score at 1 min |
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Notes | Hypotension was defined as a decrease in SBP to < 70% baseline or < 90 mmHg | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomisation according to sealed envelopes"; no further details |
Allocation concealment (selection bias) | Unclear risk | As above |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "A technician prepared the calculated volume of pentastarch and covered it with a black bag to blind the anaesthetist to the volume administered." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not reported but probably done |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No losses reported |
Selective reporting (reporting bias) | Unclear risk | Not all expected outcomes were reported |
Other bias | Low risk | Similar baseline characteristics |