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Идёт набор NCT05873218

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

Фаза IV С лечением Labor

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Ephedrine, Normal Saline Placebo.
Кому может быть актуально
Состояния в реестре: Labor. Базовые параметры: 18 лет — 55 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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).

Вмешательства

  • Препарат Ephedrine
    The intervention will be up to two 7.5 mg doses of ephedrine given after the placement of a combined spinal epidural with 25 mcg intrathecal fentanyl timed 3 and 15 minutes after intrathecal opiate administration.
  • Препарат Normal Saline Placebo
    Placebo will be administered at matching rate.

Первичные конечные точки

  • Incidence of category II fetal heart rate tracing [Срок оценки: day 1, 30 minutes after administration of intrathecal opiate]
Вторичные конечные точки (10)
  • Incidence of uterine tetanic contractions [Срок оценки: day 1, 30 minutes after administration of intrathecal opiate]
  • Incidence of uterine hypertorus [Срок оценки: day 1, 30 minutes after administration of intrathecal opiate]
  • Incidence of fetal bradycardia [Срок оценки: day 1, 30 minutes after administration of intrathecal opiate]
  • Incidence of rescue administration of ephedrine, terbutaline, or nitroglycerin [Срок оценки: day 1, 30 minutes after administration of intrathecal opiate]
  • Incidence of antihypertensive treatment after ephedrine administration [Срок оценки: day 1, 30 minutes after administration of intrathecal opiate]
  • Incidence of urgent/emergent cesarean delivery [Срок оценки: day 1, 30 minutes after administration of intrathecal opiate]
  • Incidence of hypotension [Срок оценки: day 1, 30 minutes after administration of intrathecal opiate]
  • Average HR changes [Срок оценки: day 1, 30 minutes after administration of intrathecal opiate]
  • Average blood pressure changes [Срок оценки: day 1, 30 minutes after administration of intrathecal opiate]
  • Number of patients with systolic blood pressure under 90 mmHG [Срок оценки: End of study, at 6 months]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Четверное слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Icahn School of Medicine at Mount SInai — New York

Идентификаторы

NCT: NCT05873218 · STUDY-22-01334

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗