Ozkan 2004.
Study characteristics | ||
Methods | RCT | |
Participants | 150 women Inclusion criteria: absence of any systemic illness or fetal pathology, undergoing CS under spinal anaesthesia |
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Interventions |
Crystalloid preload versus colloid preload versus crystalloid preload + prophylactic ephedrine versus colloid preload + prophylactic ephedrine Group1: Ringer's lactate IV 1000 mL Group 2: Ringer's lactate IV 1000 mL + ephedrine 15 mg Group 3: Ringer's lactate IV 1000 mL + ephedrine 30 mg Group 4: gelatine 500 mL solution Group 5: gelatine 500 mL + ephedrine 15 mg Group 6: gelatine 500 mL + ephedrine 30 mg Unclear whether standardised spinal anaesthetic technique and dose Hypotension treated with additional Ringer's lactate infusions while hypotensive periods longer than 3 min were treated with 5 mg ephedrine IV |
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Outcomes |
Maternal: hypotension; heart rate; nausea; vomiting; vasopressor requirement Neonatal: stated that there were no significant differences in neonatal outcomes, but these outcomes were not described |
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Notes | Hypotension defined as < 20% of baseline | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method not described |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding not stated |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding not stated |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Losses to follow‐up not stated |
Selective reporting (reporting bias) | Unclear risk | Not apparent, but not well reported |
Other bias | High risk | Variable dose of local anaesthetic used for spinal anaesthesia |