Jorgensen 2000.
Study characteristics | ||
Methods | RCT | |
Participants | 120 women Exclusion criteria: pre‐eclampsia, arterial hypertension or multiple pregnancy Setting: Denmark |
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Interventions |
Warm versus cold crystalloid preload Group 1: cold (21 degrees centigrade 0.9% saline preload) Group 2: warm (37 degrees centigrade saline preload) All women received a standardised spinal anaesthetic technique and dose as well as 5 mg IV ephedrine after spinal injection. |
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Outcomes | Maternal: hypotension; heart rate; arm discomfort; shivering; nausea; vomiting | |
Notes | Hypotension was defined as < 70% decrease in SAP from baseline or 100 mmHg or less. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation: "computer generation" |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment: "sealed envelopes" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding: not double‐blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding: not double‐blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Losses to follow‐up: 7/120 women were withdrawn from study, 2 because of failed spinal anaesthesia, 1 because of violation of selection criteria, and 5 because of protocol violations |
Selective reporting (reporting bias) | Low risk | None apparent |
Other bias | Low risk | None apparent |