Calvache 2011.
Study characteristics | ||
Methods | RCT | |
Participants | 80 women Inclusion criteria: ASA I/II women aged 18‐45 years with an uncomplicated singleton pregnancy at term who were scheduled for caesarean under spinal anaesthesia Exclusion criteria: pregnancy‐induced hypertension, cardiac disease, diabetes, fetal complications and women in labour: post hoc exclusions (surgery lasting > 2 h; requirement for perioperative sedation; conversion to general anaesthesia, surgical complications such as intraoperative haemorrhage, protocol violations) Setting: Colombia |
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Interventions |
Wedge versus supine position Group 1: wedge after intrathecal injection women were placed from the left lateral position to the supine position, with a right‐lumbar pelvic wedge (wooden, 35 cm long, 20 cm wide and with 20 degrees inclination), placed at the right posterior‐superior iliac crest and lumbar region Group 2: supine: after intrathecal injection, women were placed from the left lateral position to the supine position All women received no premedication, standardised oxygen therapy, standardised spinal anaesthetic technique and dose, and standardised crystalloid co‐load Hypotension was treated with IV boluses of ethylephrine 1 mg until hypotension was corrected. Bradycardia was treated with 0.5 mg atropine. |
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Outcomes | Maternal: hypotension BP; vasopressor requirements (median ethylephrine consumption); nausea; vomiting; bradycardia | |
Notes | Hypotension was defined as a 25% reduction in SBP from baseline. Bradycardia was defined as heart rate < 40 bpm. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated sequence |
Allocation concealment (selection bias) | Unclear risk | "Randomly allocated" ... "by independent anesthetist"; no further details provided |
Blinding of participants and personnel (performance bias) All outcomes | High risk | A single unblinded anaesthetist performed spinal anaesthesia, positioning of women, anaesthetic management and data collection |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Data analysis was blinded, but not mentioned if outcome assessment was blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up |
Selective reporting (reporting bias) | High risk | No neonatal outcomes reported |
Other bias | Low risk | Similar baseline characteristics |