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

Kundra 2008.

Study characteristics
Methods RCT
Participants 60 women
Inclusion criteria: ASA class I and II, single term pregnancies, scheduled for elective caesarean under spinal anaesthesia
Exclusion criteria: pre‐existing or pregnancy‐induced hypertension, known cardiovascular disease or contraindications to spinal anaesthesia
Setting: India
Interventions Ephedrine versus crystalloid preload
Group 1: ephedrine: ephedrine infusion prepared in 0.9% NS (1 mg/mL), started prophylactically at a rate of 5 mg/min for the first 2 min and then at a rate of 1 mg/min for the next 18 min, following administration of spinal anaesthetic
Group 2: crystalloid preload: Ringer's lactate 500 mL, infused rapidly over 15‐20 min before institution of spinal anaesthetic
All women received a standardised spinal anaesthetic technique and dose followed by a standardised crystalloid infusion.
Hypotension requiring intervention received 5 mg IV bolus ephedrine, repeated if necessary.
Outcomes Maternal: hypotension; induction to birth time; total ephedrine dose; adverse effects; heart rate
Neonatal: Apgar scores; umbilical venous gases
Notes Hypotension was defined as a > 20% fall in SBP
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Randomly divided into two groups"
Allocation concealment (selection bias) Unclear risk Sealed envelope
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Described as "single‐blinded" but unlikely that blinding was possible as women in the ephedrine group had 2 separate IV lines established, while those in the crystalloid group had only 1 line
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not reported
Incomplete outcome data (attrition bias)
All outcomes Low risk None reported
Selective reporting (reporting bias) Unclear risk Neonatal outcomes not reported in a form that could be used in this review
Other bias Low risk Similar baseline characteristics