drugset / Trial / NCT02062801

Prophylactic Ephedrine and Combined Spinal Epidurals for Labor

NCT02062801

Phase 4 Completed 710 enrolled Sharp HealthCare
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2012-01
Primary completion
2013-04
Completion
2013-10

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ephedrine Small molecule 10 mg Intravenous

Indications

No indication recorded.