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

Singh 2016.

Study characteristics
Methods RCT
Participants 50 women
Inclusion criteria: primiparous, full‐term parturients, aged 18‐40 years, ASA I, scheduled for elective CS
Exclusion criteria: refusal of regional anaesthesia, contraindications to spinal anaesthesia, fetal abnormalities, known allergy to any of the drugs used in the study, pregnancy‐induced hypertension or parturients with SBP > 140 mmHg, history of diabetes mellitus, cardiovascular or cerebrovascular and any chronic diseases
Setting: India
Interventions Ephedrine versus control
Group 1: 1 mL 5 mg ephedrine IV immediately after SAB
Group 2: 1 mL 0.9% NaCl IV immediately after SAB
All women received standardised monitoring, standardised crystalloid IV fluid, standardised spinal anaesthetic technique and dose.
Treatment of hypotension involved rapid infusion of Ringer's lactate and 5 mg IV ephedrine.
Bradycardia treated with 0.6 mg IV atropine sulfate.
Outcomes Maternal: incidence of hypotension, reactive hypertension, number of patients requiring rescue ephedrine, total dose of rescue ephedrine (mg), bradycardia, nausea/vomiting, average time to delivery
Neonatal: Apgar scores at 1 min and 5 min
Notes Hypotension was defined as a decrease in SBP of > 20%
Bradycardia was defined as heart rate < 60 bpm
Reactive hypertension: SBP > 140 mmHg
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomisation
Allocation concealment (selection bias) Unclear risk Not mentioned
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blinded. Study solution prepared by person not involved in the study
Blinding of outcome assessment (detection bias)
All outcomes Low risk Study staff recorded outcomes
Incomplete outcome data (attrition bias)
All outcomes Low risk All patients completed protocol
Selective reporting (reporting bias) Low risk Not evident
Other bias Unclear risk None evident