Unlugenc 2015.
| Study characteristics | ||
| Methods | RCT | |
| Participants | 90 women Inclusion criteria: ASA I/II, singleton uncomplicated pregnancy at full term gestation undergoing elective CS under spinal anaesthesia Exclusion criteria: significant co‐existing disease such as pre‐eclampsia and hepato‐renal disease, pregnancy pre‐induced hypertension, being in active labour or requiring emergency CS, any contraindication to regional anaesthesia such as local infection or bleeding disorders Setting: Turkey |
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| Interventions |
Rapid crystalloid coload versus rapid colloid coload versus slow crystalloid coload Group 1: 1000 mL Ringer's lactate at maximum rate Group 2: 1000 mL 6% HES at maximum rate Group 3: 1000 mL Ringer's lactate at minimum rate All fluids were commenced immediately after induction of spinal anaesthesia. All women received standardised fasting regimen, standardised monitoring, standardised cannulation, standardised crystalloid coload (10 mL/kg/hour) via a separate cannula, standardised spinal anaesthetic technique and dose, standardised positioning, standardised oxygen therapy. Hypotension was treated with IV ephedrine 10 mg. If heart rate was < 50 bpm, 0.5 mg atropine was administered IV. |
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| Outcomes |
Maternal: incidence of hypotension, total fluid volumes, ephedrine requirements, bradycardia, hypoxaemia, excessive sedation, pruritis, dizziness, nausea and vomiting Neonatal: umbilical artery pH/PaO2/PaCO2/HCO3‐, Apgar scores at 1 min and 5 min |
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| Notes | Hypotension was defined as SBP < 80% of baseline (prenatal) or < 90 mmHg. Bradycardia was defined as heart rate < 50 bpm. Hypoxaemia was defined as SpO2 < 95%. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation |
| Allocation concealment (selection bias) | Low risk | Fluid in non‐transparent bag |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessors blinded to patient group. "Demographic data (age, height, weight, parity and gravity) and duration of surgery were noted by an observer blinded to the treatment group. Systolic and diastolic blood pressures (SBP, DBP), heart rate and peripheral oxygen saturation (SpO2) were recorded by an anaesthetist blinded to the patient group." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up |
| Selective reporting (reporting bias) | Low risk | Not apparent |
| Other bias | Low risk | None identified |