Tawfik 2014.
| Study characteristics | ||
| Methods | RCT | |
| Participants | 210 women Inclusion criteria: elective caesarean, ASA I‐II, singleton pregnancy Exclusion criteria: age < 19 or > 40 years, height < 150 or > 185 cm, weight < 60 or > 100 kg, BMI > 40 kg/m², chronic or pregnancy‐induced hypertension, baseline SBP < 100 or > 140 mmHg, diabetes mellitus, cardiovascular, cerebrovascular or renal disease, haemoglobin < 100g/L, patients in labour, any contraindication to spinal anaesthesia, preterm (< 37 weeks gestation), multiple pregnancy, polyhydramnios or known fetal abnormalities Setting: Egypt |
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| Interventions |
Colloid preload versus crystalloid coload Group 1: colloid preload – 6% HES 130/0.4 in 0.9% sodium chloride 500 mL within 15 min before induction of spinal anaesthesia Group 2: crystalloid coload – 1000 mL of Ringer's acetate using a pressuriser as rapidly as possible starting at time of intrathecal injection All women received IV cannulation, routine monitoring, a standardised crystalloid infusion after administration of study solution, a standardised spinal anaesthetic technique and dose. Hypotension was treated with IV ephedrine 5 mg bolus. Severe hypotension was treated with 10 mg IV ephedrine. Bradycardia was treated with IV atropine 0.5 mg. |
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| Outcomes |
Maternal: hypotension, bradycardia, nausea and vomiting Neonatal: Apgar scores at 1 min and 5 min and umbilical cord gases |
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| Notes | Hypotension defined as SBP < 80% baseline or < 90 mmHg Severe hypotension: SBP < 80 mmHg Maternal bradycardia defined as heart rate < 50 bpm |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers |
| Allocation concealment (selection bias) | Low risk | Sequentially numbered opaque sealed envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blinded. Anaesthetists, women, and neonatologists blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blinded. Outcomes recorded by anaesthetists and neonatologists |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 5 patients excluded due to failed spinal or protocol violation |
| Selective reporting (reporting bias) | Low risk | None apparent |
| Other bias | Low risk | None apparent |