Sujata 2012.
Study characteristics | ||
Methods | RCT | |
Participants | 100 women Inclusion criteria: ASA I‐II, elective CS under SAB Exclusion criteria: contraindication to SAB, peripartum bleeding > 1 L, multiple gestation, polyhydramnios, gestation < 37 weeks, any patient considered at high risk of DVT Setting: India |
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Interventions |
Mechanical lower limb compression versus control Group 1: mechanical pump with thigh‐level cuff applied to lower limbs in all subjects and switched on Group 2: mechanical pump with thigh‐level cuff applied to lower limbs in all subjects but not switched on All women received standardised aspiration prophylaxis, standardised monitoring, standardised spinal anaesthetic technique and dose, standardised crystalloid coloading and maintenance, standardised positioning and standardised oxytocic administration. Hypotension was treated with IV ephedrine 6 mg, repeated every 3 min as needed. |
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Outcomes |
Maternal: BP, heart rate, SpO2 recorded every 3 min for 1 h. Total volume of IV fluid given, total ephedrine dose Neonatal: Apgar scores |
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Notes | Hypotension defined as a decrease in SBP > 20% baseline | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Sealed envelope |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Anaethetist caring for women during caesarean blinded. Possible that blinding may have been broken |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | As above |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Group 1 – 3 women excluded due to pregnancy‐induced hypertension Group 2 – 5 women excluded due to pregnancy‐induced hypertension |
Selective reporting (reporting bias) | Low risk | Not apparent |
Other bias | Low risk | Not apparent |