Ngan Kee 2004a.
Study characteristics | ||
Methods | RCT | |
Participants | 50 women Inclusion criteria: term singleton pregnancies scheduled for elective caesarean under spinal anaesthesia Exclusion criteria: pre‐existing or pregnancy‐induced hypertension, cardiovascular or cerebrovascular disease, known fetal abnormality or contraindication to spinal anaesthesia Setting: Hong Kong, China |
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Interventions |
Phenylephrine versus control Group 1: phenylephrine IV immediately after intrathecal injection; 100 µg/min for 3 min Group 2: control (saline infusion plus rescue IV bolus of phenylephrine (100 µg) when SAP < 80% baseline Note: women in the phenylephrine group were given phenylephrine 100 µg/min whenever SAP was less than baseline. All women received a standardised spinal anaesthetic technique and dose. |
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Outcomes |
Maternal: hypotension; BP; nausea and vomiting; bradycardia requiring intervention; phenylephrine dose; incision to birth time Neonatal: umbilical arterial blood gases; umbilical venous blood gases; Apgar scores |
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Notes | Hypotension defined as SAP < 80% baseline | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Computer‐generated randomization codes" |
Allocation concealment (selection bias) | Low risk | "Codes contained in sealed, sequentially numbered envelopes" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Double blind"; "two identical syringes"; investigators and women were blinded to the contents of the syringes |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | As above |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Losses to follow‐up: none (although there was insufficient cord blood to measure pH in 1 neonate) |
Selective reporting (reporting bias) | Low risk | Appears to report all |
Other bias | Low risk | None evident |