Romdhani 2014.
Study characteristics | ||
Methods | RCT | |
Participants | 105 patients undergoing elective caesarean section Inclusion criteria: term singleton pregnancies, not in labour, elective caesarean, appropriate for spinal anaesthesia Exclusion criteria: pre‐eclampsia, weight > 110 kg, < 150 cm tall, allergy to HES, known fetal abnormalities, contraindication for spinal anaesthesia, sensitive block height that exceeded T4, haemodynamic instability caused by a surgical complication, failed spinal anaesthesia Setting: Tunisia |
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Interventions |
HES vs crystalloid preload Group 1: 500 mL of 6% HES 130/0.4 Group 2: 1500 mL of 9% normal saline solution Both groups received bolus 30 min prior to spinal anaesthesia Both groups received rescue ephedrine |
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Outcomes |
Maternal: hypotension; heart rate; dose of ephedrine; nausea and vomiting Neonatal: umbilical blood pH; Apgar at 1 min and 5 min |
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Notes | Hypotension defined as a 20% drop in systolic blood pressure from baseline. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not reported |
Selective reporting (reporting bias) | Low risk | Most expected outcomes reported |
Other bias | Low risk | Not apparent |