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. 2020 Jul 1;2020(7):CD002251. doi: 10.1002/14651858.CD002251.pub4

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
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.
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))
Notes Hypotension defined as SBP < 100 mmHg or fall of > 20% from baseline
Lack of blinding acknowledged
Protocol violations acknowledged
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