Ouerghi 2010.
| Study characteristics | ||
| Methods | RCT | |
| Participants | 62 women Inclusion criteria: ASA physical status 1 and 2, term singleton pregnancy undergoing elective CS under spinal anaesthesia Exclusion criteria: pre‐existing or pregnancy‐induced hypertension, women with cardiac, renal or other end‐organ disease, women in active labour, placenta praevia, contraindications to neuraxial block, emergency delivery Setting: Tunisia |
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| Interventions |
Crystalloid preload versus control Group 1: rapid preload infusion of 20 mL/kg Ringer's lactate, 15 min before the spinal block Group 2: no preload All women received a standardised spinal anaesthetic technique and dose with standardised surgical positioning. Hypotension (requiring intervention) was treated immediately with rapid fluid infusion and ephedrine 6 mg IV and repeated whenever necessary. |
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| Outcomes |
Maternal: hypotension; nausea; vomiting; pruritus; dizziness; time to hypotension; heart rate Neonatal: Apgar at 1 min and 5 min |
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| Notes | Hypotension was defined as 20% or more fall below the pre‐induction level, or systolic pressure < 100 mmHg | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Randomly assigned"; no further details given |
| Allocation concealment (selection bias) | Unclear risk | "Sealed envelope" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | An independent investigator who recorded all variables was blinded to the anaesthetic technique used (however the paper did not report how this blinding was achieved) |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | As above; plus Apgar score was assessed by a paediatrician who was unaware of group assignment |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 2/62 – 1 from each group (both due to inadequate sensory level (< T6)) |
| Selective reporting (reporting bias) | Unclear risk | Some maternal outcomes not reported completely; only 1 neonatal outcome reported |
| Other bias | Unclear risk | Similar baseline characteristics |