Pouta 1996.
Study characteristics | ||
Methods | RCT | |
Participants | 22 women Inclusion criteria: healthy women undergoing elective CS at term, indications being breech presentation, contracted pelvis or previous CS Exclusion criteria: multiple gestation, fetal and maternal complications and contraindications to spinal anaesthesia, active labour |
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Interventions |
Colloid preload versus crystalloid preload Group 1: 500 mL 6% HES prior to spinal anaesthesia Group 2: 1000 mL Ringer's lactate prior to spinal anaesthesia All women received standardised aspiration prophylaxis, standardised crystalloid coload, standardised spinal anaesthetic and dose, and standardised surgical positioning. |
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Outcomes |
Maternal: hypotension; data expressed as mean (SD) rather than discrete incidence of hypotension; heart rate; CVP; haematocrit; ANP; endothelin‐1 (ET‐1) assays (central and peripheral); blood loss Neonatal: birthweight; umbilical arterial ANP; ET‐1 assays; pH (expressed as mean (SEM)) |
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Notes | Hypotension defined as SBP < 90 mmHg or less than 80% of baseline | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Methods not described |
Allocation concealment (selection bias) | Unclear risk | Methods not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding not mentioned |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Losses to follow‐up not stated |
Selective reporting (reporting bias) | Unclear risk | Unclear reporting |
Other bias | Unclear risk | Unclear reporting |