Dyer 2004.
Study characteristics | ||
Methods | RCT | |
Participants | 50 women Inclusion criteria: less than 90 kg, ASA I and II, singleton pregnancy, presenting for elective caesarean under spinal anaesthesia Exclusion criteria: pre‐eclamptic women Setting: South Africa |
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Interventions |
Crystalloid: preload versus rapid infusion Group 1: preload – modified Ringer's lactate, 20 mL/kg preload 20 min before spinal Group 2: coload – rapid infusion of an equivalent volume of modified Ringer's lactate immediately after induction of spinal All women received a standardised spinal anaesthetic technique and dose. Hypotension < 80% of baseline treated with 5 mg boluses of ephedrine; < 70% of baseline treated with 10 mg ephedrine until a return to within 80% of baseline |
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Outcomes |
Maternal: hypotension; BP; heart rate; time to block; induction to incision times; incision to birth times; anaesthesia and surgery times; blood loss; urine output; nausea; ephedrine dose Neonatal: birthweight; Apgar scores; umbilical arterial pH; umbilical arterial base deficit |
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Notes | Hypotension defined as BP < 80% baseline | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomly allocated" – methods not described |
Allocation concealment (selection bias) | Unclear risk | "Allocation card contained within a sealed envelope" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | "Since there were clearly pre‐defined target MAPs for vasopressor administration for each individual, the study was not blinded" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | As above |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Losses to follow‐up: none |
Selective reporting (reporting bias) | Low risk | None apparent |
Other bias | Low risk | None apparent |