Hasan 2012.
Study characteristics | ||
Methods | RCT | |
Participants | 90 women Inclusion criteria: ASA I‐II, age 20‐35 years, weight 45‐60 kg, height 153‐165 cm Exclusion criteria: pregnancy‐induced hypertension, chronic hypertension, pre‐eclampsia, twin pregnancy, fetal compromise, diabetes mellitus, polyhydramnios, renal, liver or heart disease, coagulopathy Setting: Bangladesh |
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Interventions |
Crystalloid preload versus colloid preload versus combination preload Group 1: Ringer's lactate 20 mL/kg preloading Group 2: HES 6% 8 mL/kg preloading Group 3: combination of RL 10 mL/kg and HES 6% 4 mL/kg preloading All women received standardised cannulation, standardised spinal anaesthetic technique and dose, standardised surgical positioning, standardised oxygen therapy and standardised oxytocin dose after delivery Hypotension was treated with IV boluses of ephedrine 5 mg and rapid infusion of Ringer's lactate in all 3 groups |
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Outcomes |
Maternal: systolic, diastolic and mean BP measurements; total dose of ephedrine; total volume of IV fluid given Neonatal: Apgar scores |
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Notes | Hypotension defined as SBP less than 100 mmHg AND less than 20% of the baseline BP | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Unclear method. "Randomisations were done using card sampling" |
Allocation concealment (selection bias) | Low risk | Anaesthetist who generated the random sequence infused the allocated fluid behind a screen set, separate from the outcome assessor. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and outcome assessors were blinded; however, the personnel who generated the random sequence and infused the fluid were not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | As above |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants included in final analysis |
Selective reporting (reporting bias) | Low risk | None apparent |
Other bias | Low risk | None apparent |