At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prophylactic Ephedrine to Reduce Fetal Bradycardia After Combined Spinal Epidural Labor Analgesia: a Randomized Double Blind Placebo-controlled Study
In Brief
A Phase 4 clinical trial evaluating Ephedrine and Placebo for Labor Pain. Completed, enrolled 710 participants across 1 site.
Detailed Summary
The combined spinal epidural (CSE) technique has become increasingly popular for labor pain because of its rapid onset and superior first stage analgesia. However, increased risk for early profound fetal bradycardia (EPFB) following CSE continues to be a concern. Various factors are implicated in the etiology of EPFB but the cause is unknown. Ephedrine administration prior to CSE analgesia may help reduce the risk of EPFB, but to date, nobody has studied the impact of a single dose of intravenous (IV) ephedrine given at the time of CSE administration during labor. The purpose of this study is to measure the incidence of EPFB after combined spinal epidural analgesia using standard definitions. The incidence of EPFB will be compared between patients who receive prophylactic ephedrine or placebo at the time of CSE placement.
Study Details
Timeline
Interventions
Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (\<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea
Patients received normal saline (placebo) administered immediately after combined spinal epidural (CSE) placement