Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction Af
Labor analgesia is an important component of the care of laboring patients. A known side effect of combined spinal and epidural anesthesia (a type of labor analgesia) is an increased incidence of category II fetal heart rate tracing (defined below) and low blood pressure. The study team aims to study if a prophylactic
| Condition(s) | Labor |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | Labor analgesia is an important component of the care of laboring patients. A known side effect of combined spinal and epidural anesthesia (a type of labor analgesia) is an increased incidence of category II fetal heart rate tracing (defined below) and low blood pressure. The study team aims to study if a prophylactic dose of ephedrine will decrease the occurrence of this type of tracing after combined spinal epidural (CSE) anesthesia placement. Ephedrine is not currently routinely used as prevention for category II tracings or low blood pressure. The use of Ephedrine in this study is investigational (this is the first time that the drug has been studied for its effect on these conditions). Fetal heart rate (FHR) tracings are classified into three categories. In clinical practice, FHR trac |
| Who can participate | Inclusion Criteria: * Women aged 18-55 years * Requesting labor analgesia * Able to provide informed written consent * Category 1 fetal tracing prior to placement of neuraxial anesthesia Exclusion Criteria: * Refusal of neuraxial anesthesia * History of hypertension * Suspected pre-eclampsia * Category 2 or 3 fetal tracing prior to placement of neuraxial anesthesia |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Icahn School of Medicine at Mount Sinai |
| Locations | New York, New York, United States |
| Start date | 2023-06-26 |
| NCT ID | NCT05873218 |
| Official listing | https://clinicaltrials.gov/study/NCT05873218 |