Jacob 2012.
| Study characteristics | ||
| Methods | RCT | |
| Participants | 100 women Inclusion criteria: age 20‐40 years, ASA I‐II, singleton uncomplicated pregnancy, scheduled for elective caesarean under spinal anaesthesia Exclusion criteria: chronic hypertension, pregnancy‐induced hypertension, eclampsia, known cardiovascular disease, haematocrit < 30%, any contraindication to spinal anaesthesia, height < 150 cm Setting: India |
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| Interventions |
Crystalloid preload versus crystalloid coload Group 1: 15 mL/kg over 20 min before placement of spinal block Group 2: 15 mL/kg of Ringer's lactate over 20 min starting as soon as CSF was tapped All women received standardised aspiration prophylaxis, standardised cannulation, standardised spinal anaesthetic technique and dose, standardised surgical positioning and standardised oxytocin regimen after delivery. Hypotension was treated with crystalloid boluses and 6 mg of ephedrine given intravenously every 3 min until SBP recovered to baseline value. The choice of crystalloid and the volume administered was left to the judgement of the attending anaesthetist. Bradycardia was treated with IV atropine 0.6 mg bolus. |
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| Outcomes |
Maternal: hypotension, ephedrine requirement for hypotension, nausea and vomiting, pruritus, headache, hypertension, shivering, time from induction‐delivery and uterine incision to delivery, total IV fluid, blood loss Neonatal: Apgar scores at 1 min and 5 min, umbilical artery and vein blood gas measurements |
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| Notes | Hypotension was defined as decrease in SBP to < 80% of baseline or SBP < 90 mmHg (whichever was lower). Bradycardia was defined as heart rate less than 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) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Neonatologist blinded Anaesthetist – not reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not reported |
| Selective reporting (reporting bias) | Unclear risk | Not reported |
| Other bias | Unclear risk | Not reported |