Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After CSE
Icahn School of Medicine at Mount Sinai · NCT05873218
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–55 · Women only
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 4
- Target enrollment
- 100
- US sites recruiting
- 1
- Study start
- June 26, 2023
- Record last updated
- May 6, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is 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).
Being studied: Ephedrine; Normal Saline Placebo
Conditions: Labor
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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
Recruiting US locations
Icahn School of Medicine at Mount SInai
New York, NY 10029
Site contact: Daniel Katz, MD · daniel.Katz@montsinai.org
Study contacts (from the official record)
- Daniel Katz, MD · 212-241-7475 · daniel.katz@mountsinai.org
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