El‐Mekawy 2012.
Study characteristics | ||
Methods | RCT | |
Participants | 90 women Inclusion criteria: ASA I, singleton pregnancy, term gestation, non‐life‐threatening cause for emergency CS under spinal anaesthesia (prolonged labour or dystocia, failed labour induction or amniotic rupture) Exclusion criteria: patient refusal, fetal distress, known fetal abnormalities, cardiovascular, renal or liver diseases, chronic hypertension or gestational hypertension, coagulation disorders, and those with total or partial spinal anaesthesia failure Setting: Egypt |
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Interventions |
Crystalloid co/postload versus colloid co/postload versus ephedrine infusion Group 1: 0.5 mL/kg/min Ringer's lactate via infusion pump: co/post loading started at time of spinal injection and continued after spinal injection with until fetus delivery (clamping of umbilical cord) Group 2: 0.5 mL/kg/min Voluven (6% HES 130/0.4 in isotonic NaCl solution) via infusion pump: co/post loading started at time of spinal injection and continued after it with until fetus delivery Group 3: ephedrine infusion at 1 mg/min via infusion pump commenced immediately after spinal anaesthesia until fetus delivery. Accompanied by infusion of Ringer's lactate at minimal infusion rates required to keep vein open Hypotension treated by 5 mg bolus of IV ephedrine every 2 min until SBP returned to normal value in all groups Bradycardia treated immediately using 0.5 mg atropine IV Nausea and vomiting treated with 10‐20 mg IV metoclopramide when unrelated to hypotension or not corrected by ephedrine bolus alone |
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Outcomes |
Maternal: BP, heart rate, adverse effects (nausea, vomiting, dizziness, chest symptoms, dyspnoea, tachypnoea), total IV fluid given, total ephedrine dose, time from spinal anaesthesia to delivery of fetus (clamping of umbilical cord) Neonatal: heart rate was monitored by CTG continuously until delivery; Apgar scores at 1 min and 5 min; arterial blood gas sample taken from umbilical cord for blood gas analysis (pH, pCO2) within 2 min after delivery |
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Notes | Hypotension was defined as 20% decrease in SBP from the baseline. Maternal bradycardia was defined as heart rate < 60 bpm. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomisation not reported |
Allocation concealment (selection bias) | Unclear risk | Closed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Neither participants nor personnel were blinded, however this was unlikely to have impacted upon the measured results. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessor not blinded; however this was unlikely to have impacted upon the measured results. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | None reported |
Selective reporting (reporting bias) | Low risk | None apparent |
Other bias | Low risk | Non apparent |