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. 2020 Jul 1;2020(7):CD002251. doi: 10.1002/14651858.CD002251.pub4

Ozkan 2004.

Study characteristics
Methods RCT
Participants 150 women
Inclusion criteria: absence of any systemic illness or fetal pathology, undergoing CS under spinal anaesthesia
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
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
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