Dahlgren 2005.
Study characteristics | ||
Methods | RCT | |
Participants | 110 women Inclusion criteria: healthy women with normal term singleton pregnancies presenting for elective CS Setting: Sweden |
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Interventions |
Crystalloid versus colloid preload Group 1: acetated Ringer's solution, 1000 mL, preceded by 20 mL 15% saline 0.9% IV Group 2: dextran 60 3%, 1000 mL, preceded by 20 mL dextran 1 IV All women received a standardised spinal anaesthetic technique and dose. Hypotension was managed by a standardised regimen of ephedrine dosing. |
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Outcomes |
Maternal: hypotension; clinically significant hypotension; severe hypotension ephedrine consumption; blood loss Neonatal: umbilical artery < pH 7.2; pCO2; base deficit |
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Notes | Hypotension defined as SAP dropping below 100 mmHg; clinically significant hypotension as drop in SAP > 20% below baseline and severe hypotension defined as SAP < 80 mmHg | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | "Sealed envelope" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Double‐blinded" – solution prepared and administered by an anaesthetic nurse not otherwise involved in the care of the woman (including the initial injection) |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Losses: 1/110 – 1 woman from crystalloid group excluded due to protocol violation; 1 woman allocated to crystalloid subsequently found to have received colloid. |
Selective reporting (reporting bias) | High risk | Not all outcomes listed in the paper were reported |
Other bias | Low risk | Some baseline differences, e.g. 32% nulliparous in the crystalloid group compared with 21% in the colloid group |