Sutherland 2001.
Study characteristics | ||
Methods | RCT | |
Participants | 100 women Inclusion criteria: ASA I or II women undergoing elective CS Exclusion criteria: contraindication to spinal anaesthesia or thigh circumference > 64 cm |
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Interventions |
Lower limb compression versus control Group 1: TED stockings applied before arrival in theatre and lower limb sequential compression device inflated immediately after spinal injection Group 2: no mechanical prophylaxis All women received a standardised spinal anaesthetic technique with dose adjusted according to subject's height. Hypotension was managed with a standardised ephedrine regimen. |
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Outcomes |
Maternal: hypotension; systolic, diastolic and mean BP; level of sensory block; ephedrine requirement; time to first episode of hypotension Neonatal: Apgar scores at 1 min and 5 min (expressed as n with score < 9); umbilical artery pH (expressed as mean (SD)) |
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Notes | Hypotension defined as SBP < 100 mmHg or fall of > 20% from baseline Lack of blinding acknowledged Protocol violations acknowledged |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method not described |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Neither participants nor investigators blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | As above |
Incomplete outcome data (attrition bias) All outcomes | High risk | Losses to follow‐up: no dropouts but 46/100 protocol violations (ephedrine administered in error on 17 occasions (9 intervention, 8 control), ephedrine omitted in error on 29 occasions (10 intervention, 19 control) |
Selective reporting (reporting bias) | Unclear risk | Not apparent |
Other bias | Unclear risk | Not apparent |