Idehen 2014.
Study characteristics | ||
Methods | RCT | |
Participants | 70 women Inclusion criteria: elective CS, ASA I or II Exclusion criteria: multiple pregnancy, weight > 115 kg, height < 150 cm, diabetes mellitus, hypertensive diseases in pregnancy intra‐uterine death, age < 18 years or > 40 years, patients on diuretics, contraindication to central neuraxial blockade Setting: Nigeria |
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Interventions |
Combination crystalloid/colloid preload versus crystalloid preload Group 1: 1000 mL crystalloid/colloid (6% pentastarch/Ringer's lactate, 750 mL/250 mL) combination IV preload Group 2: 500 mL colloid (6% pentastarch) IV preload Women in both groups received the same aspiration prophylaxis, IV cannulation, spinal anaesthesia technique and dose. Hypotension treated with 3 mg aliquots of ephedrine and rapid infusion of fluid. |
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Outcomes |
Maternal: incidence of hypotension, ephedrine requirement, nausea and vomiting, maximum block height, blood loss, urine output Neonatal: Apgar scores at 1 min and 5 min, birth asphyxia, meconium aspiration |
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Notes | Hypotension defined as SBP < 80% of baseline | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Blind balloting |
Allocation concealment (selection bias) | Unclear risk | Not reported, but double‐blinding |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Syringes were preloaded and wrapped |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Investigator who assessed the outcomes was blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | None reported |
Selective reporting (reporting bias) | Low risk | None apparent |
Other bias | Low risk | None apparent |