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Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After CSE

RecruitingPhase 4Ages 18 Years - 55 YearsFemaleIcahn School of Medicine at Mount Sinai
NCT05873218 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 tracing categories are used as a guide to obstetric management and suggest the following approach: * C

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📋 Eligibility rules (as published)
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
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What it tests

  • Ephedrine
  • Normal Saline Placebo
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Where

1 site
Icahn School of Medicine at Mount SInai
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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