French 1999.
Study characteristics | ||
Methods | RCT | |
Participants | 160 women Inclusion criteria: ASA I or II undergoing elective caesarean under spinal anaesthesia |
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Interventions |
Colloid preload versus crystalloid preload Group 1: pentastarch 10% in 0.9% saline 15 mL/kg Group 2: Hartmann's solution 15 mL/kg All women received a standardised anaesthetic technique with variable anaesthetic dose, followed by standardised surgical positioning. |
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Outcomes |
Maternal: BP; hypotension; block height; uterine incision to birth interval Neonatal: Apgar scores at 1 min and 5 min; cord pH |
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Notes | Hypotension was defined as SBP below 90 mmHg or < 70% below baseline. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation method not described |
Allocation concealment (selection bias) | Low risk | Adequate: randomisation code by pharmacy and study drugs "covered with a black plastic bag to ensure blinding" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding: not specifically stated but anaesthetist and women presumably were blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | As above |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Not reported |
Selective reporting (reporting bias) | Low risk | None apparent |
Other bias | Low risk | None apparent |