Damevski 2011.
Study characteristics | ||
Methods | RCT | |
Participants | 40 women Inclusion criteria: ASA I, women aged 21‐28 years with normal pregnancies, elective caesarean for breech presentation, cephalopelvic disproportion, re‐operation Exclusion criteria: body weight > 90 kg, women who refused caesarean Setting: Macedonia |
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Interventions |
Ephedrine infusion versus crystalloid preload Group 1: ephedrine: continuous fast‐drop infusion of 500 mL Ringer's solution with 50 mL ephedrine, commenced immediately after venous cannulation for spinal anaesthesia, and continued until the umbilical cord was clamped Group 2: crystalloid: 20 mL/kg Ringer's solution, warmed to room temperature, commenced 20‐30 min prior to spinal anaesthesia, and continued until the umbilical cord was clamped All women received a standardised spinal anaesthetic technique and dose, standardised oxygen therapy, and standardised oxytocin regimen. Hypotension requiring intervention received 5 mg IV boluses of ephedrine in group 1 (ephedrine group) and 10 mg IV boluses of ephedrine in group 2 (crystalloid group). |
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Outcomes |
Maternal: hypotension; quantity of crystalloid; quantity of ephedrine; nausea and vomiting Neonatal: Apgar scores |
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Notes | Hypotension defined as SBP < 100 mmHg | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomised" – no further details reported |
Allocation concealment (selection bias) | Unclear risk | As above |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up |
Selective reporting (reporting bias) | Unclear risk | Not all outcomes available (e.g. Apgar scores presented only as medians) |
Other bias | Low risk | Similar baseline characteristics |