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. 2020 Jul 1;2020(7):CD002251. doi: 10.1002/14651858.CD002251.pub4

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
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).
Outcomes Maternal: hypotension; quantity of crystalloid; quantity of ephedrine; nausea and vomiting
Neonatal: Apgar scores
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