Gomaa 2003.
Study characteristics | ||
Methods | RCT | |
Participants | 90 women Inclusion criteria: healthy pregnant women (25 to 40 years) undergoing elective caesarean under spinal anaesthesia Exclusion criteria: women known to be hypertensive Setting: Egypt |
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Interventions |
Ephedrine versus phenylephrine versus control Group 1: ephedrine, 50 mg IM Group 2: phenylephrine, 4 mg IM Group 3: 2 mL saline IM All study drugs given 10 min before spinal anaesthesia All women received a standardised crystalloid preload and a standardised spinal anaesthetic technique and dose followed by standardised surgical positioning. |
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Outcomes |
Maternal: hypotension Neonatal: cord/neonatal blood (reported as mean and SD); Apgar < 8 at 5 min (reported as mean and SD) |
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Notes | Hypotension was defined as 25% decrease in MAP from baseline | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method not described |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding: drugs were prepared by an anaesthetic assistant not involved in the study and injected by an anaesthetist not involved in data collection or care of the women |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | As above |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Losses to follow‐up: not stated but losses unlikely |
Selective reporting (reporting bias) | Low risk | Not apparent |
Other bias | Low risk | Not apparent |