Prophylactic Intravenous Ephedrine to Minimize Fetal Bradycardia After Combined Spinal-epidural Labour Analgesia: A Randomized Controlled Study

Abstract

Background The combined spinal-epidural (CSE) technique for relief of labour pain offers both rapid onset and superior first-stage analgesia. Nevertheless, the known increased risk for early profound fetal bradycardia (EPFB) following CSE continues to be a concern that often limits its use. The purpose of this study was to determine if giving prophylactic intravenous ephedrine at the time of CSE administration would reduce EPFB.Methods We conducted this clinical trial at a large community hospital and enrolled healthy patients requesting epidural analgesia for labour. Patients were randomly assigned to receive either normal saline placebo or ephedrine 10 mg iv at the time of CSE. The primary outcome of EPFB (defined as bradycardia \ 90 beatsÁmin -1 for [ two minutes and occurring within the first 30 min after CSE) was compared between groups. The secondary outcomes included the incidence of urgent cesarean delivery, the requirement for additional doses of ephedrine, maternal blood pressure, uterine hypertonus and tachysystole, and abnormal fetal heart rate (FHR) patterns before and after CSE. Results There were 299 women randomized to the ephedrine (EPH) group and 297 randomized to the normal saline placebo (NS) group. There was no difference between groups in the incidence of EPFB (2.7% EPH group vs 4.7% NS group; relative risk, 0.57; 95% confidence interval, 0.24 to 1.33; P = 0.184). There was also no difference between groups in the incidence of Author contributions David R. Gambling, Miriam Bender, Sue Faron, and Thomas R. Farrell helped design the study. Miriam Bender, Sue Faron, and Thomas R. Farrell helped collect the data. David R. Gambling, Miriam Bender, and Sue Faron helped analyze the data and write the manuscript. David R. Gambling helped conduct the study. Sue Faron helped educate the nursing staff for study participation. Dale Glaser was involved in the statistical analysis, power analysis, proposed analysis, and the results. Thomas R. Farrell helped recruit patients and educate the nursing staff about the study protocol, and he reviewed the manuscript. All authors reviewed the analysis of the data.

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“…Later, ephedrine can also be used for neuropathic oedema although it is not licensed but indicated in the British National Formularies (BNF). Emerging clinical trials are investigating therapeutic potential in other diseases such as labour pain, vasopressors, and preeclampsia [23][24][25]. Another example is atropine, which in 2001 had licenses with the Medicines and Healthcare products Regulatory Agency (MHRA) for treatment like bradycardia and prevention of cholinergic effects on the heart after surgery.…”