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临床试验/NCT05873218
NCT05873218招募中4 期

Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After Combined Spinal Epidural on Laboring Parturients

Icahn School of Medicine at Mount Sinai2 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2023年6月26日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
135
试验地点
2
主要终点
Incidence of category II fetal heart rate tracing

研究概览

简要总结

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:

  • Category I tracing is "reactive" and reassuring → may continue labor
  • Category II tracing is neither category I nor category III. For obvious reasons, category II is the broadest and largest category, consisting of various FHR tracing patterns that do not fit into either category I or category III.
  • Category III tracing is non-reassuring → expedited vaginal or cesarean delivery recommended.

A Category II tracing is not diagnostic. Most pregnancies have at least one Category II tracing. There is not always an identifiable reason for a Category II tracing.

Ephedrine is a medication that causes an increase in heart rate and blood pressure while also causing some degree of relaxation of the uterus therefore improving uterine blood flow. It has been used in the obstetric population for over 50 years without issues. The dose that the research team will administer, 7.5 mg, is below the dose the research team will often administer to treat hypotension (low blood pressure).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18-55 years
  • Requesting labor analgesia
  • Able to provide informed written consent
  • Category 1 fetal tracing prior to placement of neuraxial anesthesia

排除标准

  • Refusal of neuraxial anesthesia
  • History of hypertension
  • Suspected pre-eclampsia
  • Category 2 or 3 fetal tracing prior to placement of neuraxial anesthesia

研究组 & 干预措施

Placebo

Placebo Comparator

3 minutes after the placement of a combined spinal epidural with 25 mcg fentanyl, 2.5cc 0.9% NS IV will be administered to the patient, 12 minutes later, a second dose of , 2.5cc 0.9% NS will be administered to the patient.

干预措施: Normal Saline Placebo (Drug)

Ephedrine

Experimental

3 minutes after the placement of a combined spinal epidural with 25 mcg fentanyl, 7.5 mg ephedrine IV will be administered to the patient, 12 minutes later, a second dose of 7.5mg will be administered to the patient as long as the patient is not hypertensive (BP no greater than 140/90)

干预措施: Ephedrine (Drug)

结局指标

主要结局

Incidence of category II fetal heart rate tracing

时间窗: day 1, 30 minutes after administration of intrathecal opiate

Incidence of category II fetal heart rate tracing up to 30 minutes after administration of intrathecal opiate

次要结局

  • Incidence of fetal bradycardia(day 1, 30 minutes after administration of intrathecal opiate)
  • Incidence of urgent/emergent cesarean delivery(day 1, 30 minutes after administration of intrathecal opiate)
  • Number of patients with systolic blood pressure under 90 mmHG(End of study, at 6 months)
  • Incidence of hypotension(day 1, 30 minutes after administration of intrathecal opiate)
  • Average blood pressure changes(day 1, 30 minutes after administration of intrathecal opiate)
  • Incidence of uterine tetanic contractions(day 1, 30 minutes after administration of intrathecal opiate)
  • Incidence of antihypertensive treatment after ephedrine administration(day 1, 30 minutes after administration of intrathecal opiate)
  • Incidence of uterine hypertorus(day 1, 30 minutes after administration of intrathecal opiate)
  • Incidence of rescue administration of ephedrine, terbutaline, or nitroglycerin(day 1, 30 minutes after administration of intrathecal opiate)
  • Average HR changes(day 1, 30 minutes after administration of intrathecal opiate)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Katz

Vice Chair of Education Department of Anesthesiology, Pain, & Perioperative Medicine Icahn School of Medicine at Mount Sinai Director of Education Mount Sinai HELPS Center

Icahn School of Medicine at Mount Sinai

研究点 (2)

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