drugset / Trial / NCT03623256

Comparison of Intrathecal Versus Epidural Fentanyl on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia

NCT03623256 ↗

Phase 4 Unknown 558 enrolled Augusta University
RandomizedParallel-groupSingle-blindPrevention

Summary

There have been studies reporting that combined spinal-epidural (CSE) with fentanyl and bupivacaine produce fetal bradycardia, (M.Kuczkowski, 2004) (Abrão K, 2009 ). It is unknown whether any differences in risk exist between fentanyl and bupivacaine when used as a part of the CSE procedure. Some authors have reported cases of parturients who developed uterine hyperactivity and fetal bradycardia after subarachnoid administration of fentanyl during labor. (D'Angelo \& Eisenach, 1997) (Friedlander JD, 1997). It has been suggested that uterine hypertonus, leading to non-reassuring fetal heart rate tracings, might be an etiologic factor in these situations. (Landau, 2002). We propose this study to test the hypothesis that administration of epidural fentanyl is associated with a lower incidence of fetal bradycardia compared to intrathecal fentanyl.

Timeline

Start
2019-10-28
Primary completion
2023-10-01
Completion
2023-10-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 1.25 mg Intrathecal
Comparator Fentanyl Other / unclassified 25 ug Intrathecal
Comparator Fentanyl Other / unclassified 100 ug Intrathecal

Indications