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Prophylactic ephedrine to reduce fetal bradycardia after combined spinal epidural labor analgesia: a randomized double blind placebo-controlled study
Abstract Number: T 1
Abstract Type: Original Research
Background: The combined spinal epidural (CSE) technique is increasingly popular for labor analgesia because of its rapid onset and superior first stage analgesia compared with epidural analgesia. However, increased risk for early profound fetal bradycardia (EPFB) following CSE is a concern. At our hospital, a previous study documented a rate of 8% EPFB. Various factors are implicated but the cause is unknown. Ephedrine administration prior to CSE or epidural analgesia may help reduce the risk of EPFB, but the literature shows mixed results. This study compares prophylactic intravenous (IV) ephedrine vs. placebo on the incidence of early profound fetal bradycardia following CSE labor analgesia.
Methods: In this randomized, double blind, placebo controlled trial, healthy term parturients requesting labor analgesia were randomly assigned to CSE in a sitting position followed immediately by IV study drug (taken from a sealed opaque envelope that was prepared by pharmacy): one ml of either 10mg ephedrine (EPH) or normal saline (NS). All patients received a 500ml co-load of Ringers Lactate solution and were placed in a lateral position after CSE placement. Blood pressure (BP), fetal heart rate (FHR) and uterine contraction pattern were recorded for 30 minutes post CSE placement. Standard protocols for supplemental ephedrine administration were used and documented for treatment of maternal hypotension and/or early profound fetal bradycardia within 30 minutes after CSE. Preliminary data were analyzed using ANOVA (means), Chi Square (rates), or simple effects (group difference over time) tests using SPSS 18.02. For all tests, α was set at 0.05.
A priori power analysis determined that 600 subjects are needed to show a 50% reduction in the 8% expected incidence of EPFB.
Results: To date we have studied 174 NS and 169 EPH patients, with no significant differences between groups in terms of age, gestational age, BMI, parity, cervical dilatation, type and length of labor, pain score and dose of IV fentanyl at time of CSE. The use of supplemental ephedrine during the study period was significantly lower in the EPH group (16% EPH vs. 30% NS; p=0.002). However, mean total ephedrine dose (study plus supplemental dosing) was higher in the EPH group (12.2mg EPH vs. 3.8mg NS; p <0.005). Interestingly, there was a lower than expected incidence of EPFB in both groups, with no significant difference between groups (3.6% EPH vs. 4.1% NS; p=0.811). There was no significant difference between groups in uterine tachysystole rate after CSE. Simple effects analysis showed no difference between groups in mean FHR before and after CSE, but significant differences in mean maternal systolic pressures after CSE (119.8 pre/112.8 post EPH vs. 120.8 pre/106.2 post NS; F=28.57, p<.05). Labor outcomes were similar between groups.
Conclusions: To date, this study indicates that prophylactic intravenous ephedrine does not influence the rate of EPFB after CSE in la