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

Mercier 2014.

Study characteristics
Methods RCT
Participants 167 women
Inclusion criteria: ASA I‐II, elective caesarean under spinal anaesthesia, aged > 18 years, weight > 60 kg and < 95 kg, term singleton pregnancy (> 37 weeks' gestation)
Exclusion criteria: concomitant diseases (e.g. pregnancy‐induced hypertension, diabetes mellitus, cardiovascular or cerebrovascular disease, coagulation disorders), fetal complications, contraindications to spinal anaesthesia or HES administration, emergency CS, women who received IV fluid prior to admission to theatre
Setting: multicentre, France
Interventions Colloid versus crystalloid preload
Group 1: HES: 500 mL 6% HES 130/0.4, followed by 500 mL Ringer's lactate
Group 2: RL: 500 mL of Ringer's lactate, followed by second infusion of 500 mL Ringer's lactate
All women received standardised aspiration prophylaxis, standardised monitoring, standardised anaesthetic technique and dose.
Maternal bradycardia treated with atropine 0.5‐1 mg IV
Hypotension treatment: SBP > 95% baseline – no treatment, SBP 94‐80% baseline received 50 μg phenylephrine, SBP 79%‐90% of baseline received 100 μg phenylephrine, SBP < 70% of baseline received 150 μg phenylephrine. Sustained nausea and vomiting was treated with ondansetron 4 mg IV.
Outcomes Maternal: incidence of hypotension; time of onset of hypotension; symptomatic hypotension; nausea and vomiting; dizziness; minimum heart rate; bradycardia; atropine and phenylephrine requirement
Neonatal: Apgar scores at 1 min and 5 min, umbilical arterial and venous pH
Notes Hypotension defined as SBP < 80% of baseline
Bradycardia defined as heart rate < 50 bpm
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomisation sequence using SAS software; blocks of 4
Allocation concealment (selection bias) Unclear risk Not mentioned
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind: "study fluids were provided in indistinguishable 500 mL bottles
in both groups with randomisation code, as previously pictured."
Blinding of outcome assessment (detection bias)
All outcomes Low risk Double‐blind
Incomplete outcome data (attrition bias)
All outcomes Low risk Clearly reported in study results
11 protocol violations in HES group, and 10 in the Ringer's group
Intention‐to‐treat analysis
Selective reporting (reporting bias) Low risk Not apparent
Other bias High risk Fully funded by Fresenius Kabi, the company that produces HES