Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After CSE
Sponsored by Icahn School of Medicine at Mount Sinai
About this trial
Last updated a year ago
Study ID
STUDY-22-01334
Status
Recruiting
Type
Interventional
Phase
Phase 4
Placebo
No
Accepting
18 to 55 Years
Female
Trial Timing
Ended 3 months ago
What is this trial about?
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).
What are the participation requirements?
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
Locations
Location
Status
Recruiting