Jabalameli 2011.
Study characteristics | ||
Methods | RCT | |
Participants | 150 women Inclusion criteria: singleton pregnancy with ASA physical status I or II scheduled for elective caesarean under spinal anaesthesia, without pre‐existing systemic disease or pregnancy‐induced hypertension, preterm labour or signs of onset of labour, known fetal abnormalities, or without contraindications to spinal anaesthesia Exclusion criteria: any significant history of maternal medical or obstetric illness and any fetal compromise in current pregnancy Setting: Iran |
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Interventions |
Crystalloids versus colloids versus ephedrine Group1: crystalloid preload: Ringer's lactate solution (15 mL/kg) infused in 30 min before spinal injection. Group 2: colloid preload: colloid solution (Hexamel 7 mg/kg) infused in 30 min before spinal injection. Group 3: ephedrine: ephedrine (15 mg IV bolus) immediately after spinal injection, infused in 45 s. All women received a standardised spinal anaesthetic technique and dose, a standardised crystalloid coload, standardised leg wrapping and standardised surgical positioning. Hypotension (requiring intervention) received rescue boluses of 5 mg ephedrine given each 5 min |
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Outcomes |
Maternal: hypotension (SBP); hypotension, bradycardia; BP; heart rate; ephedrine requirement; vomiting; nausea; hypertension Neonatal: Apgar at 1 min and 5 min, umbilical cord blood pH, NACS |
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Notes | Hypotension was defined as SBP < 90 mmHg or > 20% below baseline. Bradycardia was defined as heart rate < 50 bpm. Hypertension was defined as SBP > 140 mmHg or > 20% baseline values. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random number table |
Allocation concealment (selection bias) | Unclear risk | "Randomised" – not further specified except that sampling method was "consecutive" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Reported that women and all staff involved in the study were blind to the protocol used; however, colloid and crystalloids were preloads while ephedrine was given immediately after the spinal injection. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Nurse assessing the severity of nausea and physician measuring neonatal outcomes were blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up |
Selective reporting (reporting bias) | Low risk | Most expected outcomes were reported (although nausea was only reported as a continuous measure). |
Other bias | Low risk | Similar baseline characteristics |