Kuhn 2016.

Study characteristics
Methods	RCT
Participants	120 women Inclusion criteria: healthy pregnant women, term pregnancy, elective caesarean delivery, aged 18‐40 years, height 160‐180 cm, pre‐pregnancy BMI < 31 kg/m² Exclusion criteria: pre‐existing or gestation hypertension/pre‐eclampsia/cardiovascular or cerebrovascular disease/psychiatric or somatic disease (other then well‐treated mild asthma/thyroid hypofunction) or contraindications to spinal anaesthesia Setting: Norway
Interventions	Phenylephrine versus leg wrapping versus control Group 1: phenylephrine (initial bolus 0.25 μg/kg followed by infusion 0.25 μg/kg/min) + sham leg‐wrapping Group 2: leg wrapping + IV placebo infusion Group 3: no treatment consisting of sham leg wrapping + IV placebo infusion All women received no premedication or IV prehydration, standardised IV cannulation, standardised monitoring (via LiDCOplus monitor including arterial line), standardised positioning, standardised spinal anaesthesia technique and dose, standardised crystalloid co‐hydration, standardised oxygen therapy, standardised oxytocin regimen. Leg wrapping or sham leg wrapping performed prior to spinal anaesthesia (refer to below for method of blinding) Study medicine infusion commenced at time of spinal anaesthesia, and ceased if SAP > 150 mmHg for > 3 min Hypotension was treated with IV bolus of 30 μg phenylephrine If hypotension was combined with bradycardia, or MAP < 60 mmHg, an IV bolus of 5 mg ephedrine was administered.
Outcomes	Maternal: extent of decrease in SBP; change in cardiac output, systemic vascular resistance, stroke volume; heart rate; nausea and vomiting, pruritus Neonatal: umbilical artery and vein pH and BE, Apgar score
Notes	Hypotension was defined as SAP < 80% of mean SAP or SAP < 90 mmHg Bradycardia was defined as heart rate < 55 bpm
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Hospital pharmacy performed block randomisation into 3 groups of equal size using a pool of sealed and shuffled envelopes
Allocation concealment (selection bias)	Low risk	Sealed envelopes for leg wrapping, neutral syringes
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blinded Study medicine prepared in 50 mL syringes containing either phenylephrine or placebo, marked with randomisation number and neutral study information Instructions for therapeutic or sham wrapping placed into a sealed envelope for each patient Leg wrapping performed by specifically trained technical assistants after visual shielding between head of bed and lower extremities. Subsequently, legs were covered prior to positioning in lateral for spinal anaesthesia.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Randomisation codes not revealed until all measurements recorded
Incomplete outcome data (attrition bias) All outcomes	Low risk	Group 1 Ph: 2 excluded (1 GA, 1 low‐quality data) Group 2 LW: 2 excluded (2 low‐quality data) Group 3 Con: 4 excluded (4 low‐quality data)
Selective reporting (reporting bias)	Low risk	Most expected outcomes were reported
Other bias	Low risk	Funding from South‐Eastern Norway Regional Authority through government research grant